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Regulatory Authority

Regulatory authority(ies), relevant office/departments, oversight roles, contact information
Regulatory review and approval processes, renewal, monitoring, appeals, termination
Regulatory fees (e.g., applications, amendments, notifications, import) and payment instructions

Ethics Committee

Ethics review landscape, ethics committee composition, terms of reference, review procedures, meeting schedule
Ethics committee review and approval processes, renewal, monitoring, termination
Ethics review fees and payment instructions
Authorization of ethics committees, registration, auditing, accreditation

Clinical Trial Lifecycle

Submission procedures for regulatory and ethics reviews
Essential elements of regulatory and ethics submissions and protocols
Regulatory and ethics review and approval timelines
Pre-trial approvals, agreements, clinical trial registration
Safety reporting definitions, responsibilities, timelines, reporting format, delivery
Interim/annual and final reporting requirements

Sponsorship

Sponsor role and responsibilities, contract research organizations, representatives
Site and investigator criteria, foreign sponsor responsibilities, data and safety monitoring boards, multicenter studies
Insurance requirements, compensation (injury, participation), post-trial access
Protocol and regulatory compliance, auditing, monitoring, inspections, study termination/suspension
Electronic data processing systems and records storage/retention
Responsible parties, data protection, obtaining consent

Informed Consent

Obtaining and documenting informed consent/reconsent and consent waivers
Essential elements for informed consent form and other related materials
Rights regarding participation, information, privacy, appeal, safety, welfare
Obtaining or waiving consent in emergencies
Definition of vulnerable populations and consent/protection requirements
Definition of minors, consent/assent requirements, conditions for research
Consent requirements and conditions for research on pregnant women, fetuses, and neonates
Consent requirements and conditions for research on prisoners
Consent requirements and conditions for research on persons who are mentally impaired

Investigational Products

Description of what constitutes an investigational product and related terms
Investigational product manufacturing and import approvals, licenses, and certificates
Investigator's Brochure and quality documentation
Investigational product labeling, blinding, re-labeling, and package labeling
Investigational product supply, storage, handling, disposal, return, record keeping

Specimens

Description of what constitutes a specimen and related terms
Specimen import, export, material transfer agreements
Consent for obtaining, storing, and using specimens, including genetic testing
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Quick Facts

Clinical trial application language
Regulatory authority & ethics committee review may be conducted at the same time
Clinical trial registration required
In-country sponsor presence/representation required
Age of minors
Specimens export allowed

Regulatory Authority

Last content review/update: October 1, 2024

Health Canada

As per the CanadaFDA, the CanadaFDR, and the G-CanadaCTApps, Health Canada (HC) is the competent authority responsible for clinical trial approvals, oversight, and inspections in Canada. The G-CanadaCTApps states that the HC grants permission for clinical trials to be conducted in the country, and regulates the sale and importation of drugs for use in clinical trials in accordance with the CanadaFDR provisions.

As per CAN-29, HC is one (1) of five (5) federal agencies within Canada’s “Health Portfolio” overseen by the Minister of Health. Per CAN-31, HC assesses clinical trial protocols to evaluate participant protection and safety; reviews drug quality; assures institutional ethics committee review; verifies principal investigator qualifications; and monitors and reviews adverse drug reactions. As delineated in CAN-23, HC’s Health Products and Food Branch (HPFB) is the national authority that regulates, evaluates, and monitors therapeutic and diagnostic product safety, efficacy, and quality, and reviews the information submitted in the clinical trial application. Per CanadaFDA, if the Minister believes on reasonable grounds that the use of a therapeutic product, other than the intended use, may present a risk of injury to health, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage, or testing of the therapeutic product for the purpose of preventing, managing, or controlling the risk of injury to health.

Per CAN-16, HPFB’s activities are carried out by nine (9) Directorates and one (1) office, including the Pharmaceutical Drugs Directorate (PDD) and the Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Per CAN-18 and CAN-17, the PDD and the BRDD, respectively, regulate pharmaceutical drugs, and biological drugs and radiopharmaceuticals for human use. In addition, the G-CanadaCTApps indicates that the PDD’s Office of Clinical Trials (OCT) and the BRDD’s Office of Regulatory Affairs (ORA), among others, are directly involved with the clinical trial review and approval process for pharmaceutical, biological, and radiopharmaceutical drugs. Per the G-MDSA, the Therapeutic Products Classification Committee (TPCC) may be consulted when it is not clear whether a product should be classified as a drug or device. The committee makes recommendations on the classification of a product as either a drug, medical device, or combination product. If a product does not readily meet one (1) of the statutory definitions, other regulatory areas of HC are asked to participate in the committee's discussion.

As per CAN-41, Health Canada has established a regulatory innovation agenda, which aims to provide more regulatory flexibility to support innovative research and health product development. For more details, see CAN-41.

Per CAN-10, Canada is an official member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Per CAN-50, HC-implemented ICH guidelines take precedence over other HC guidance when they are not consistent. Per CAN-50, Canada has implemented the ICH’s Guideline for Good Clinical Practice E6(R2) (CAN-52). Also see CAN-50 for details on all the ICH guidelines implemented by HC. For any questions or comments, contact HC’s ICH Coordinator via email at ich@hc-sc.gc.ca.

Contact Information

According to the G-DrugApp and CAN-18, Health Canada PDD contact information is as follows:

Office of Clinical Trials
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Address Locator: 3105A
Health Canada
Ottawa, Ontario, Canada
K1A 0K9

Phone (General Enquiries): 613-957-0368
Fax (General Enquiries): 613-952-7756
Office of Clinical Trials Inquiries:
oct.enquiries-requetes.bec@hc-sc.gc.ca

Per CAN-17, the following is the contact information for biologic clinical trials:

Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Building 6, Address Locator: 0601B
100 Eglantine Driveway
Tunney’s Pasture
Ottawa, Ontario, Canada
K1A 0K9

Phone: 613-863-8405
General Enquiries E-mail:
brdd.dgo.enquiries@hc-sc.gc.ca

What is the Health Products and Food Branch?
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Our Regulatory Innovation Agenda
Contact Us (Office of Clinical Trials)
1.2, 1.4, 2.1, and Appendix 1
Where to send drug submission applications
5
Part II (Section 30 (1.2) and Section 30.01)
Part C (Division 5 (C.05.001, C.05.002, C.05.005, and C.05.006))
Last content review/update: February 9, 2024

In Uganda, the National Drug Authority (NDA) and the Uganda National Council for Science and Technology (UNCST), in collaboration with the Uganda National Health Research Organisation (UNHRO), are involved in clinical trial oversight.

National Drug Authority

As per the NDPA-CTReg, the G-CTConduct, and the G-TrialsGCP, the NDA is the regulatory authority responsible for clinical trial approval and inspections in Uganda. The NDA grants permission for clinical trials to be conducted in Uganda in accordance with the provisions of the NDPA-Act.

As stated in the NGHRP, the NDA regulates safety, quality, efficacy, handling, and use of drugs or drug related products and devices in research. According to UGA-29, the Clinical Trials Unit in the NDA’s Directorate of Product Safety is responsible for reviewing and approving clinical trial applications, conducting clinical trial site inspections for compliance with good clinical practices, and developing guidance documents.

Please note: Uganda is party to the Nagoya Protocol on Access and Benefit-sharing (UGA-3), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see UGA-21.

Uganda National Council for Science and Technology

As delineated in the NDPA-CTReg, the NGHRP, and the G-CTConduct, in addition to obtaining the NDA’s permission to conduct research in Uganda, an applicant must obtain approval in the form of a research permit from the UNCST, or from an institution authorized by the UNCST.

As per UGA-30, the UNCST was established by the UNCST-Act as a semi-autonomous government agency under the Ministry of Science, Technology, and Innovation. The mandate of the UNCST is to develop and implement policies and strategies for integrating science and technology into national development policies; to advise the government of Uganda on policy matters necessary for promoting science and technology; and coordinate and guide national research and development in Uganda.

As per the NGHRP, the UNCST registers and, in liaison with the Research Secretariat in the Office of the President of Uganda, clears all research intended to be carried out in the country.

The G-CTConduct and the G-UNCSTreg also state that applicants must register their research proposals, obtain approval, and be issued a research permit from the UNCST prior to initiating a study.

Uganda National Health Research Organisation

The UNHRO-Act authorizes the UNHRO to register and renew research protocols, and to implement and enforce an ethical code of conduct for health research in Uganda. The UNHRO, in collaboration with the UNCST, conducts a scientific and ethical review of all health research protocols for approval. According to the NGHRP, the UNHRO also collaborates with the UNCST to register all health research protocols centrally at the UNCST. No additional information regarding UNHRO’s role is available.

Contact Information

National Drug Authority

According to UGA-23 and UGA-10, the NDA’s contact information is as follows:

National Drug Authority
Head Office
Plot 93, Buganda Road, after St. Catherine Hospital
P.O. Box 23096
Kampala, Uganda

Reception Phone: +256 [0]417 788 100
Directorate of Product Safety Phone: +256 [0]417 788 124
Directorate of Inspectorate Services Phone: +256 [0]417 788 129
WhatsApp: +256 74002080
Innovation & Research Desk: [0]800 101 999 (Toll Free Line), 0791 415555 (WhatsApp)
Email: ndaug@nda.or.ug

Uganda National Council for Science and Technology

As per the G-UNCSTreg and UGA-25, the UNCST’s contact information is as follows:

Uganda National Council for Science and Technology
Plot 6, Kimera Road, Ntinda
P.O. Box 6884
Kampala, Uganda
Phone: +256 414 705500
Fax: +256 414 234579
Email: info@uncst.go.ug

Uganda National Health Research Organisation

Per UGA-26, the UNHRO’s contact information is as follows:

Uganda National Health Research Organisation
Plot 2, Berkeley Lane, Entebbe
P.O. Box 465
Entebbe, Uganda

Tel/Fax: +256 414 321766
Email: unhrodesk4@gmail.com

Introduction and 6.0
3.1-3.4
6.0-7.0
1.6-1.7
Part I (3) and Part IV (40)
4-5 and 15
Part II
Part II (3-6) and Schedule 1 (Form 29)

Scope of Assessment

Last content review/update: July 26, 2024

Overview

In accordance with the CanadaFDA, Health Canada (HC) reviews, evaluates, and approves applications for clinical trials using authorized therapeutic products. HC also approves the sale or importation of drugs for use in clinical trials. (See the Manufacturing & Import section for additional information on importation.) As delineated in the CanadaFDR and the G-CanadaCTApps, institutional ethics committee (EC) review is required for each clinical trial site and may occur in parallel with HC’s clinical trial application (CTA) review and approval. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. See CAN-23 and CAN-19 for background information on HC’s scope of assessment.

Per the CanadaFDA, a “therapeutic product” is defined as a drug or device, or any combination of drugs and devices, but does not include natural health products; and “therapeutic product authorization” refers to a license that is approved for the import, sale, advertisement, manufacture, preparation, preservation, packaging, labeling, storage, or testing of a therapeutic product. As per the G-CanadaCTApps, a drug is defined as a pharmaceutical, biologic, gene therapy, blood product, vaccine, and radiopharmaceutical for human use that is to be tested in a clinical trial. HC’s scope of assessment includes clinical trials (Phases I - III) using:

  • Drugs not authorized for sale in Canada in development and in comparative bioavailability studies
  • Marketed drugs where the proposed use of the drug for one (1) of the following is different: indication(s) and clinical use; target patient populations(s); route(s) of administration; or dosage regimen(s)

Clinical Trial Review Process

As set forth in the G-CanadaCTApps and CAN-23, HC’s Health Products and Food Branch (HPFB) coordinates the CTA approval process. The G-CanadaCTApps and CAN-23 state that prior to initiating the trial, the sponsor must file a CTA to the appropriate HPFB Directorate. CTAs involving pharmaceutical drugs should be sent to the Pharmaceutical Drugs Directorate (PDD), and CTAs involving biologics and/or radiopharmaceuticals should be sent to the Biologic and Radiopharmaceutical Drugs Directorate (BRDD).

The G-CanadaCTApps and CAN-23 indicate that upon receipt of a CTA, the HPFB Directorate (PDD/BRDD) screens the application package for completeness. If deficiencies are found, the Directorate sends the sponsor a Request for Clarification or a Screening Rejection Letter. If the Directorate finds the application complete, an acknowledgement letter is issued to indicate the 30-day default review period commenced on the date of receipt.

Per the G-CanadaCTApps, once a clinical trial is authorized, the sponsor is allowed to sell or import a drug for use in a trial, if a CTA has been filed with HC and has not received an objection within 30 days. As delineated in the G-CanadaCTApps and CAN-23, if the clinical trial is authorized, a No Objection Letter (NOL) is issued. If the CTA is rejected, a Not Satisfactory Notice (NSN) is issued. As specified in the G-CanadaCTApps and CAN-23, during the review period, the Directorate may request additional information from the sponsor, who has two (2) calendar days to provide such information. Please see the G-CanadaCTApps for special requirements regarding reviews of comparative bioavailability studies and joint reviews of clinical trials covering a combination of devices, biologics, and pharmaceuticals. See the Submission Process section for detailed application submission requirements.

Per the G-CanadaCTApps, soon after HC issues an NOL, it will publish the following information about the clinical trial in HC’s publicly accessible database:

  • Protocol number
  • Protocol title
  • Drug name
  • Medical condition
  • Study population
  • Authorization date
  • Sponsor name
  • HC control number
  • Trial start and end dates, if known

The CanadaFDR and the G-CanadaCTApps also delineate that a clinical trial application-amendment (CTA-A) is required for proposed changes to a previously authorized study when the changes to clinical trial drug supplies affect the quality or safety of the drug, or when the changes to an authorized protocol alter the risk to clinical trial participants, or both. CTA-As must be authorized by HC prior to implementation of the changes. However, if the sponsor is required to immediately implement changes because the clinical trial or the use of the clinical trial drug endangers the health of participants or other persons, the sponsor may immediately make the amendment without prior review by HC. Sponsors must notify HC of this change, provide the relevant rationale in support of the immediate implementation, and file a CTA-A that clearly identifies the change and rationale for immediate implementation of the change within 15 days after the amendment implementation date. In addition, sponsors may make the following changes immediately if it notifies HC in writing within 15 days after the date of the change: a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug; or a change to the protocol that does not alter the risk to the health of a participant.

Per the CanadaFDR, HC will suspend the authorization to sell or import a drug for clinical trial purposes if it has reasonable grounds to believe that:

  • The sponsor has contravened any relevant laws or regulations
  • Any information submitted in respect of the drug or clinical trial is false or misleading
  • The sponsor has failed to comply with good clinical practices
  • The sponsor has failed to provide information or samples as required by the regulation

See the CanadaFDR for additional details on HC’s suspension and cancellation responsibilities.

What is the Health Products and Food Branch?
Clinical Trial Site Information form
1.2, 2.1, 2.3-2.7, and Appendix 1
5.1, 5.2, 5.5, and 5.6
2 and Part II (Section 30 (1.2))
Part C (Division 5 (C.05.001, C.05.002, C.05.005-.008, and C.05.016-.017))
Last content review/update: February 9, 2024

Overview

In accordance with the NDPA-CTReg, the G-CTConduct, and the G-TrialsGCP, the National Drug Authority (NDA) is responsible for reviewing, evaluating, and approving clinical trial applications for registered or unregistered medicines in Uganda. The scope of the NDA’s assessment includes all clinical trials (Phases I-IV).

Per the NDPA-CTReg and UGA-20, the NDA’s review and approval of a clinical trial application are dependent upon the applicant submitting proof in the application of institutional level ethics committee (EC) (research ethics committee (REC) in Uganda) approval and a research permit from the Uganda National Council for Science and Technology (UNCST). UGA-33 further notes that for clinical trials involving human participants, approval must be obtained through the institutional EC portal (the National Research Information Management System (NRIMS) (UGA-33)) before NDA approval. Therefore, the NDA and institutional EC reviews may not be conducted in parallel. However, the G-TrialsGCP indicates that parallel submissions may be made to the NDA and the UNCST. In that instance, the NDA would not make a final decision until after the trial receives UNCST clearance.

Clinical Trial Review Process

National Drug Authority

The NDPA-CTReg, the G-TrialsGCP, and the G-CTConduct indicate that upon receipt of a clinical trial application, the NDA initially screens the application for completeness. If the NDA is not satisfied with the information provided, the applicant will be advised in writing to provide further information or clarification. According to the G-CTConduct, the applicant must submit their responses in writing or in any other format as advised by the NDA, and in the timeframe determined by the NDA. NDA reviews are performed following a first-in first-out principle, except for clinical trials that are to be conducted in public health emergencies such as disease outbreaks, which may be exempted.

The NDPA-CTReg, as amended by the NDPA-CTRegAmdt, indicates that in considering an application for a clinical trial, the NDA must take into account the following:

  • Relevance of the clinical trial
  • Suitability of the principal investigator (PI)
  • Quality of the facilities to be used for the clinical trial
  • Adequacy and completeness of the information and procedures to obtain consent of the clinical trial participants
  • Provision for indemnity for the PI and insurance for the clinical trial participants
  • Terms of the agreement between the sponsor and the PI

Per the G-CTConduct, complete applications are given a Clinical Trial Application code. Applications verified as complete will undergo one (1) of three (3) types of reviews:

  • Internal review, which is further subdivided into expedited or routine review
  • Expert review, which involves external reviewers co-opted by the NDA following internal procedures
  • Joint reviews, which are carried out jointly with other regulatory bodies including the UNCST, Uganda National Health Research Organisation (UNHRO), and the primary EC. These reviews will be coordinated by the UNCST

Expedited review of an application is applicable for:

  • Clinical trial applications for investigational drugs to provide treatment where no therapy exists
  • Clinical trials conducted in an emergency, such as during a disease outbreak
  • Clinical trial applications that do not explicitly meet either above criterion, but are led by the Ministry of Health in the interest of a public health intervention

According to the G-CTConduct, the NDA may decide to a) authorize the clinical trial and issue a clinical trial certificate; b) request additional information to support the application; or c) reject the clinical trial application, providing reasoning. The NDA’s decision is communicated to the applicant in writing. The clinical trial certificate is valid for one (1) year from the date it is awarded (See Form 35 in Schedule 1 of the NDPA-CTReg, as amended by the NDPA-CTRegAmdt). Applicants may apply for renewal of this approval with the Application Form for Renewal of Authorisation of Clinical Trial (UGA-32). See Appendix VI of the G-CTConduct for the Checklist for Application for Authorization of Renewal of Conduct of a Clinical Trial, and UGA-2 for a related clinical trial application screening renewal form.

The G-CTConduct states that any new information that becomes available regarding the product, such as new adverse effects or changes in formulation or the manufacturer, must be submitted to the NDA as soon as possible.

The NDPA-CTReg and the G-CTConduct indicate that the NDA may, on its own initiative, make amendments to the conditions for conducting a clinical trial where it is necessary for the safety or scientific validity of the clinical trial. The NDA will give 15 days’ notice of the intended amendment to the sponsor and the PI with reasons for the amendment, and request a written response to the proposed amendments prior to effecting the amendments. The NDA will, in making amendments to the conditions of conducting a clinical trial, take into consideration the response of the sponsor or PI.

Per the G-CTConduct, applicants may also submit a form to amend the conditions of a clinical trial. The amendment application will be screened for completeness and will essentially be complete in the first instance if it includes all the required documents, appendices, and finished checklist. Applications which are incomplete will not be evaluated, and a letter documenting the deficiencies in the application will be issued to the applicant. The NDA may request supplementary data or documentation where applicable. The NDA will consider the favorable opinion of the EC(s), the UNCST, and other relevant information, and may request that the applicant to submit an interim clinical trial study report to support the decision. Additionally, the NDA may take other regulatory action such as an inspection of the clinical trial site or investigational product manufacturing facility for regulatory and protocol compliance prior to making a decision. The NDA may approve or reject the application and specify the reasons for rejection. The decision will be communicated to the applicant in writing.

See the G-CTConduct for detailed NDA amendment review procedures, and Appendix V of the G-CTConduct or UGA-22 for the clinical trial application amendments screening form.

As per the G-CTConduct, the NDA may at any reasonable time conduct inspections of the trial site prior to or after issuance of a clinical trial certificate. The purpose of the inspections is to assess the staff and facilities to be used or that are being used for the conduct of the clinical trial, and to verify the availability of the necessary resources and feasibility of conducting the study at the proposed site(s). These inspections will assess the compliance of the trial conduct with the conditions of the certificate. The NDA secretariat may contact the PI or sponsor notifying them of the date(s) of inspection. The secretariat will conduct inspections routinely, or as a result of a trigger. In addition, the inspections may be done jointly with the UNCST and/or the EC.

Uganda National Council for Science and Technology

According to the NDPA-CTReg, the NGHRP, and the G-CTConduct, an applicant must also submit a research proposal for review and approval to the UNCST. Per the G-UNCSTreg, the UNCST receives and reviews research protocols for their scientific merit, safety, and ethical appropriateness, and when satisfied, issues permits to conduct the research in Uganda. The research permit is granted at a national level to facilitate access to research resources within the country. The G-UNCSTreg states that as a part of its review, the UNCST liaises with the Research Secretariat in the Office of the President of Uganda to obtain security verification and clearance for the investigator. The investigator must pay a Research Administration and Clearance fee for the entire period of the research project, but such a period must not exceed five (5) years. Investigators interested in continuing a study using an approved protocol beyond the UNCST research permit expiration date should make a written request for an extension or renewal of the permit to the UNCST Executive Secretary. The request should be accompanied by a progress report, the EC approval, and any other institutional approvals, where applicable. See the G-UNCSTreg for detailed extension/renewal request submission information.

The G-UNCSTreg indicates that any changes, amendments, and addenda to the research protocol, research instruments, or the consent form must be submitted to the designated local EC or the lead agency (NDA) for review and approval prior to implementing the changes. The UNCST should be notified of the EC- or lead agency-approved changes within 10 working days.

The UNCST also reserves the right to revoke, suspend, or terminate a research permit, and, if necessary, without giving notice to the investigator, in the event of gross misconduct or violation of the G-UNCSTreg guidelines.

Introduction, 5.0-5.5, 5.7, 6.0, 7.0, 7.3, 8.0, and Appendices V and VI
1.6-1.7
Introduction, 6.0-7.0, 12.0-13.0, and 14.2
3.1-3.2
Part II (3-8 and 11) and Schedule 1 (Forms 29 and 35)

Regulatory Fees

Last content review/update: July 26, 2024

According to CAN-33, there are no fees to submit a clinical trial application in Canada.

Question 5
Last content review/update: February 9, 2024

National Drug Authority

In accordance with the NDPA-CTReg, the G-CTConduct, and the NDPA-FeesReg, applicants are responsible for paying a non-refundable processing fee to submit a clinical trial application for human drugs and vaccines (except for locally manufactured herbal drugs) to the National Drug Authority (NDA). As set forth in the NDPA-FeesReg, the following fees apply:

  • Application to undertake a clinical trial for a registered drug – $2,500 USD
  • Application to undertake a clinical trial for an unregistered drug – $4,000 USD
  • Application to amend a clinical trial application – $200 USD

Payment Instructions

According to the G-CTConduct, the application fee payment details are as follows:

National Drug Authority: TIN 1000054563
Bank: Stanbic Bank Uganda
Account numbers: 9003008068851 (US Dollars) and 903005759829 (Ugandan shillings)
Swift code: SBICUGKX
Acceptable forms of payment: cash in the bank, real time gross settlement (RTGS), electronic funds transfer (EFT), telegraphic transfer (TT), or check

Uganda National Council for Science and Technology

As delineated in the G-UNCSTreg, the Uganda National Council for Science and Technology (UNCST) charges a non-refundable Research Administration and Clearance fee of $300 USD, or its equivalent in Ugandan shillings, to register a research proposal. The UNCST will not register the protocol or issue a research permit until this fee has been paid. Permits are valid for the entire duration specified for a project. However, the fee covers a research period not to exceed five (5) years. Projects that extend beyond the initial five (5) year period are required to pay $300 USD for the extension. All applicants, excluding East African students, are responsible for paying this fee. East African students are only required to pay a fee of $50 USD. However, UGA-20 further indicates that this excludes those pursuing post doctorate studies.

Payment Instructions

The G-UNCSTreg delineates that applicants should make their payments to the UNCST bank accounts and are encouraged to make cash payments to avoid additional bank fees. An official receipt is issued once the UNCST receives a stamped copy of the bank deposit. See Section 6.0 of the G-UNCSTreg for detailed payment information.

According to UGA-20, the payment information is as follows:

Bank: Any Standard Chartered Bank
Account title: Uganda National Council for Science and Technology (UNCST)
Account numbers: 8705611811400 (US Dollars) and 0105610632101 (Ugandan shillings)
Swift code: SCBLUGKA

4.4
6.0
Part II (4)
2 and Schedule (Part 9)

Ethics Committee

Last content review/update: October 1, 2024

Overview

As indicated in the CanadaFDR and the G-CanadaCTApps, Canada has a decentralized process for the ethical review of clinical trial applications, and requires the sponsor to obtain institutional ethics committee (EC) approval for each participating trial site. (Note: institutional ECs are referred to as Research Ethics Boards (REBs) in Canada.) Canadian provinces may have varying requirements, and, therefore, the sponsor should consult with the applicable province(s) for more information.

Per CAN-35 and CAN-13, all proposed or ongoing research involving human participants carried out by, funded by, or otherwise under the auspices of Health Canada (HC) or the Public Health Agency of Canada (PHAC) must obtain approval from a joint EC representing those two (2) agencies—as well as complying with the CanadaFDR and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50. This joint EC is known as the HC-PHAC REB. Further, if an institution is conducting an HC- or PHAC-funded project, the HC-PHAC REB must review and approve the research even if it has been previously reviewed and approved by another EC. See CAN-35 for details on the HC-PHAC REB’s development, responsibilities, and composition. HC’s operational policy (CAN-13) outlines policies and procedures that the joint HC-PHAC REB must follow when reviewing clinical trials.

Institutional ECs are required to comply with the provisions delineated in the CanadaFDR, the G-CanadaCTApps, and CAN-52. Note that per CAN-50, HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. In addition, institutional ECs are guided by the G-TCPS2. Jointly developed by Canada’s three (3) federal research agencies: the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council (SSHRC), the G-TCPS2 is a policy that sets the ethical benchmark for all Canadian institutional ECs. However, only CIHR-, NSERC-, and SSHRC-funded institutions are required to comply with this guideline as a condition of funding. According to CAN-14, the CIHR, the NSERC, and the SSHRC created the Panel on Research Ethics (PRE) to promote the ethical conduct of research involving human participants. The PRE develops, interprets, and implements the G-TCPS2.

Ethics Committee Composition

As delineated in the CanadaFDR, the G-CanadaCTApps, and CAN-52, institutional ECs must have at least five (5) members representing a mixed gender composition, the majority of which are Canadian citizens or permanent residents, and must include:

  • Two (2) members from a scientific discipline, with broad experience in the relevant research methods and areas, one (1) of whom is from a medical or dental discipline
  • One (1) member knowledgeable in ethics
  • One (1) member knowledgeable in relevant Canadian biomedical research laws
  • One (1) member from a nonscientific discipline
  • One (1) community representative

The G-TCPS2 mirrors these EC composition requirements. As mentioned earlier, only CIHR-, NSERC-, and SSHRC-funded institutions are required to comply with this guidance as a condition of funding.

Terms of Reference, Review Procedures, and Meeting Schedule

According to CAN-52, institutional ECs must establish written standard operating procedures (SOPs) to cover the entire review process. The SOPs should include EC composition, meeting schedules, notifications, frequency of reviews, protocol deviations, reporting to the EC, and recordkeeping. Further, ECs should make decisions at announced meetings where a quorum is present. Only those members who participate in the EC review and discussion should vote, provide their opinion, or advise. For detailed EC procedures and information on other administrative processes, see CAN-52. For examples of EC SOPs, see CAN-13 for the HC-PHAC REB operational policy.

2 and 3
Introduction, 1.24, 1.27, and 2.6, 3
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
About the REB and Policies, Guidelines, and Resources
1.2, 1.4, 2.1, and 2.7
5.1, 5.2, 5.5, 5.6, and 5.10
Introduction and Chapter 6 (Articles 6.4 and 6.10)
Part C (Division 5 (C.05.001, C.05.002, C.05.005, C.05.006, and C.05.010))
Last content review/update: February 9, 2024

Overview

As per the G-UNCSTreg and the NGHRP, research involving human participants must be reviewed and approved by an institutional ethics committee (EC) (referred to as a research ethics committee (REC) in Uganda), which must be accredited by the Uganda National Council for Science and Technology (UNCST).

Ethics Committee Composition

The NGHRP states that an EC must have at least five (5) members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of a proposed clinical trial. Specifically, the composition should include:

  • Individuals of varying backgrounds, including consideration of gender, cultural backgrounds, and sensitivity to social issues in the community from which research participants are drawn
  • At least one (1) individual whose primary concern is scientific, and at least one (1) whose primary concern is non-scientific
  • At least one (1) individual who is unaffiliated with the institution
  • At least one (1) lay person from the community, whose primary background is not in scientific research involving human participants, and who is capable of sharing insights about the community from which participants are likely to be drawn

Additional criteria for EC membership are available in Sections 4.3 and 4.4 of the NGHRP.

Terms of Reference, Review Procedures, and Meeting Schedule

According to the NGHRP, each EC member must take at least one (1) course in human research protection within one (1) year of appointment to an EC, and thereafter, should undergo continued research ethics education at least once every two (2) years. Membership terms in any EC have a maximum three (3) year duration, after which a member is eligible for reappointment. A person may not serve as a member in more than two (2) ECs concurrently.

As set forth in the NGHRP, each EC must have written procedures, including a process to be followed for conducting reviews. The following minimum requirements must be met:

  • Meet at least once every three (3) months
  • At least 50% of members, including one (1) member representing community interests, must be present to conduct reviews
  • Project approval requires a simple majority of those members present at the meeting
  • Respond to any allegations of ethical violations in approved or rejected research projects
  • Liaise with other ECs within and outside the country to better carry out its functions
  • Submit annual performance reports to the UNCST

The NGHRP further indicates that no EC member may participate in the EC’s initial or continuing review of any project in which the member has a conflict of interest, except to provide information as may be requested by the EC. An EC may also, at its discretion, invite individuals with competence in special areas to assist in the review of protocols which require expertise beyond, or in addition to, that available in the EC. These individuals do not vote at EC meetings. See Sections 4.5.1 and 4.9 of the NGHRP for additional EC review requirements.

As per the NGHRP, an EC must also prepare and maintain the following:

  • Detailed written procedures
  • Copies of reviewed proposals and corresponding documentation (e.g., scientific evaluations, progress reports, correspondence with investigators)
  • Meeting minutes
  • Records of continuing review activities

Documents relating to research projects must be retained for at least five (5) years after the research project has been completed. All documents must be accessible for inspection and use by authorized UNCST representatives. See Section 4.6 of the NGHRP for additional EC recordkeeping requirements.

7.0
1.0, 3.1, 3.4-3.6, 4.1-4.6, and 4.8-4.9

Scope of Review

Last content review/update: October 1, 2024

Overview

According to the CanadaFDR, the G-CanadaCTApps, the G-TCPS2, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), the primary scope of information assessed by institutional ethics committees (ECs) (called Research Ethics Boards (REBs) in Canada) relates to maintaining and protecting the dignity and rights of human research participants and ensuring their safety throughout their participation in a clinical trial. ECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed vulnerable. (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations.) Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

CAN-52, which Canada has implemented per CAN-50, also states that ECs must ensure an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards. See CAN-52 for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the CanadaFDR and CAN-52, HC must approve a clinical trial application (CTA) and an institutional EC(s) must give ethical clearance prior to a sponsor initiating a clinical trial. In addition, as delineated in the CanadaFDR and the G-CanadaCTApps, institutional EC review for each clinical trial site may occur in parallel with HC’s CTA review and approval. Once HC completes its review, the department issues a No Objection Letter (NOL) if the CTA is approved. However, per the CanadaFDR, the G-CanadaCTApps, CAN-6, and CAN-30, HC will not authorize the sponsor to begin the clinical trial until an institutional EC approval for each participating trial site is submitted. The sponsor should use the Clinical Trial Site Information Form (CAN-6) to submit the required information. The CanadaFDR also states that the EC must review and approve any protocol amendments prior to those changes being implemented. For HC’s interpretation of the relevant provisions of CanadaFDR, see the G-FDR-0100.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, requires EC review and approval of research involving living human participants and human biological materials. Further, ECs must have procedures in place to receive and respond to reports of new information, including, but not limited to, safety data, unanticipated issues, and newly discovered risks.

See TCPS2-InterpReview for the Panel on Research Ethics (PRE)’s interpretations of the G-TCPS2, including on the EC’s review of secondary use of non-identifiable information, delegated review of minimal risk studies, and ongoing review.

The G-TCPS2 lays out options, procedures, and considerations for the ethics review of multi-jurisdictional research either entirely within Canada, or in Canada and other countries. An institutional EC may approve alternative review models for research with multiple ECs and/or institutions but remains responsible for the ethics and conduct of research in its jurisdiction or under its auspices regardless of where the research is conducted. See the G-TCPS2 for more information about the various review models for multi-jurisdictional research.

Per CAN-8, an attestation must be completed by the EC that reviewed and approved the clinical trial. The completed attestation must be retained by the clinical trial sponsor for a period of 15 years. The attestation should not be submitted to HC unless requested. (See the Submission Process section for detailed submission requirements.)

The G-TCPS2 directs the researcher to submit an annual report to enable the EC to evaluate the continued ethical acceptability of the research. Per the G-CanadaCTApps, in the event that an EC terminates or suspends any prior approval or favorable opinion, it must document its views in writing, clearly identifying the trial, the documents reviewed, and the date for the termination or suspension.

1.27, 2, 3, and 5.11
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
1.2, 1.4, 2.1, 2.5, and 2.7
5.1, 5.2, 5.5, 5.6, and 5.10
Introduction, and Chapters 1-2, 6, 8, and 11
Part C (Division 5 (C.05.001, C.05.005, C.05.006, and C.05.010))
Last content review/update: February 9, 2024

Overview

In accordance with the NGHRP, the central scope assessed by institutional ethics committees (ECs) (research ethics committees (RECs) in Uganda) relates to safeguarding the rights, safety, and well-being of all trial participants. An EC’s primary functions include:

  • Maintaining ethical standards of practice in research
  • Protecting participants and investigators from harm or exploitation
  • Preserving the participants’ rights and welfare
  • Providing assurance to society of the protection of participants’ rights and well-being
  • Ensuring adherence to an ethical conduct of research protocol

An EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations).

Role in Clinical Trial Approval Process

Per the NDPA-CTReg and UGA-20, proof of institutional EC approval must be submitted in a clinical trial application to the National Drug Authority (NDA). UGA-33 further notes that for clinical trials involving human participants, approval must be obtained through the institutional EC portal (the National Research Information Management System (NRIMS) (UGA-33)) before NDA approval. Therefore, the NDA and institutional EC reviews may not be conducted in parallel.

As stated in the NGHRP, the EC will notify investigators in writing about the outcome of its review. If the EC does not approve a research activity, it will include reasons for its disapproval in the written notification.

As per the NGHRP, ECs may use an expedited review process for research involving no more than minimal risk or for minor changes in previously approved research protocols during a period of one (1) year or less from which approval was given. Minor changes include an addition of a collaborator, a small change in the number of research participants, or spelling corrections. Expedited review processes may also be applied to annual renewal of studies, in which the only outstanding activity is data analysis and report writing. Major changes include, but are not limited to, significant changes in the research methodology or a change in procedures for research participants. Each EC must develop standard operating procedures to define eligibility for expedited review. See the NGHRP for more details on expedited review procedures.

According to the NGHRP, if a multicenter or collaborative trial is being conducted and the same clinical protocol is being used for all the sites, the participating institutions may enter into a joint EC review arrangement. The joint EC review must comply with the requisite ethical standards outlined in the NGHRP.

The NGHRP indicates that ECs must conduct continuing/periodic review of approved trials to ensure compliance with scientific and ethical requirements in accordance with the NGHRP. The EC must conduct the continuing review at intervals appropriate to the degree of risk, but not less than once a year, and have a plan for onsite monitoring of approved studies.

The NGHRP further delineates that changes/amendments in the research protocol cannot be implemented without prior approval from the EC, except when necessary to eliminate an apparent immediate hazard or danger to research participants. Per the NDPA-CTReg, evidence of ethical approval of the amendment to the protocol is a required element of an application to the NDA for deviation from a condition of a clinical trial.

Additionally, the NGHRP states that ECs have the authority to halt, suspend, or terminate approval of research that is not being conducted in accordance with the EC’s requirements, has been associated with unexpected serious harm to research participants, or contravenes the NGHRP. If an EC suspends or terminates its approval, it must provide a written statement for its reasons for doing so, and immediately communicate this decision to the investigator, as well as to the Uganda National Council for Science and Technology (UNCST).

3.0-5.0 and 7.1
Part II (3-8 and 10) and Schedule 1 (Forms 29 and 36)

Ethics Committee Fees

Last content review/update: July 26, 2024

Institutional ethics committees (ECs) may independently decide whether to charge fees to conduct protocol reviews. For example, an institutional EC may require industry sponsors or other for-profit organizations to pay a fee. See specific examples of institutional fee requirements in CAN-3 and CAN-1.

REB Review Fees
Last content review/update: February 9, 2024

No information is currently available.

Oversight of Ethics Committees

Last content review/update: July 26, 2024

There are no applicable regulations or guidance regarding the registration, auditing, and accreditation of institutional ethics committees (ECs).

Last content review/update: February 9, 2024

Overview

The Uganda National Council for Science and Technology (UNCST) is the central statutory body responsible for the registration and accreditation of institutional ethics committees (ECs) (research ethics committees (RECs) in Uganda). The UNCST’s NGHRP establishes a national framework for research involving humans to ensure that the rights, interests, values, and welfare of research participants are not compromised.

Registration, Auditing, and Accreditation

As per the NGHRP, the UNCST’s Accreditation Committee for RECs in Uganda (ACREC) must accredit all ECs. An organization that wishes to establish an EC must apply for accreditation of the EC at the UNCST, with assurance that the organization will comply with the requirements set forth in the NGHRP. The assurance must at the minimum include:

  • A statement of principles for protecting rights and welfare of human research participants of research conducted at or sponsored by the organization. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the organization itself
  • Assurance of availability of staff; office and meeting space for the EC; and sufficient resources to support the EC’s operations
  • A list of EC members appointed by the head of the organization or the head’s designee. The members should be identified by name, qualifications, profession, specialty, organization of affiliation, and representative capacity in the EC
  • Written standard operating procedures for the EC

The NGHRP indicates that the ACREC will review the organization’s application, and if satisfied, will accredit the EC. An EC is not permitted to commence its activities until ACREC authorization is received.

See UGA-9 for the accreditation application form and the NGHRP for details on EC establishment requirements. A list of UNCST-accredited ECs is also available through UGA-11.

3.2, 3.4-3.5, and 4.1-4.2

Submission Process

Last content review/update: July 26, 2024

Overview

In accordance with the CanadaFDR and the G-CanadaCTApps, Canada requires the sponsor to obtain clinical trial authorization from Health Canada (HC) prior to initiating the trial. The sponsor must file a clinical trial application (CTA) to the appropriate Directorate within HC’s Health Products and Food Branch (HPFB). In addition, as delineated in the CanadaFDR and the G-CanadaCTApps, the sponsor may submit a CTA for clinical trial authorization to the HC in parallel with its submission to an institutional ethics committee (EC) (known as a Research Ethics Board (REB) in Canada) for a favorable ethical opinion. However, per the CanadaFDR, the G-CanadaCTApps, CAN-6, and CAN-30, HC will not authorize the sponsor to begin the clinical trial until an institutional EC approval (provided in the required Clinical Trial Site Information (CTSI) form (CAN-6)) for each participating trial site is submitted. The HCNotice-CTSIForm indicates that the CTSI form improves efficiencies and supports the submission of CTAs using the electronic Common Technical Document (eCTD) format. See CAN-30 for instructions on filling out and submitting CAN-6.

CAN-19 provides a full list of HC’s forms for drug-related applications and submissions. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100

Regulatory Submission

Per the G-CanadaCTApps, CTAs (CAN-4) should be sent directly to the appropriate HPFB Directorate for review—the Pharmaceutical Drugs Directorate (PDD) for pharmaceutical drugs or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) for biological drugs and radiopharmaceuticals. The outer label should be clearly identified with "Clinical Trial Application." Per CAN-44, applicants must submit CTAs electronically in either eCTD format or non-eCTD format. According to the G-MDSA, HC does not accept paper copies of CTAs, CTA amendments, and CTA notifications.

The G-MDSA and the G-CanadaCTApps indicate that sponsors may request a pre-submission/application meeting with the appropriate Directorate within the HPFB if they have any questions or concerns prior to filing a CTA. Additional details on requesting a meeting and meeting procedures are available in the aforementioned guidance documents. According to CAN-4, the submission can be in French or English. For CTAs that use pharmacometric approaches, sponsors should consider the policy statements in G-Pharmacometrics. Pharmacometrics is the science of using quantitative analysis and modelling and simulation approaches to inform and enhance drug development and regulatory review. In addition, see the G-CTACell for guidance on preparing CTAs for use of cell therapy products in humans.

Per the CanadaFDR, an application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial must be submitted to HC, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer. The sponsor’s clinical trial attestation must be submitted with the application (CAN-4). For guidance on completing CAN-4, see the G-DrugApp.

eCTD Electronic Submission

As indicated in the G-eCTD, clinical trial applications in eCTD format are recommended, not mandatory. However, once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory activities for the same dossier must be filed in eCTD format. CAN-36 explains that prior to filing the first regulatory transaction for a dossier in eCTD format, the sponsor must request a dossier ID using the online dossier ID request. Per the ElecSubms, CAN-20 is the request form for biological clinical trial dossiers and CAN-21 is for pharmaceutical clinical trial dossiers. A request for a dossier ID should be sent a maximum of eight (8) weeks prior to submitting the CTA. In addition, applicants should review the Rules-eCTD for validation rules before submission. (Note: As per ElecSubms, G-eCTD and CAN-36 are only available upon request at no-reply.ereview.non-reponse@hc-sc.gc.ca. Please ensure the text 'Request for eCTD Guidance Document' is in the subject line of the email.)

Per the G-eCTD and CAN-28, all regulatory transactions in eCTD format must be sent via the Common Electronic Submissions Gateway (CESG) (CAN-25), except for those exceeding 10 gigabytes (GB) in size. The CESG allows users to submit secure regulatory transactions electronically to HC, including CTAs. The G-eCTD and CAN-36 describe how to file CTAs and other clinical trial regulatory transactions (e.g., CTA amendments, responses to requests for information, and other in-scope activities) in eCTD format to CESG. The G-eCTD clarifies that prior to using the CESG for sending transactions, sponsors must register as a trading partner. To access and use CESG, CAN-34 instructs sponsors to follow these steps:

  • Register as a trading partner with the US Food & Drug Administration (FDA) by completing the FDA Electronic Submissions Gateway (ESG) (CAN-51) registration for an account (CAN-47).
  • Send regulatory transactions to HC by selecting “HC” as the center on the FDA ESG system; CTAs intended for HC will be automatically redirected.

For detailed information on how to become a trading partner and send regulatory transactions, refer to CAN-25 and the FDA User Guide (CAN-47).

As indicated in the G-eCTD, the following media formats are acceptable for eCTD transactions greater than 10 GB: Universal Serial Bus (USB) 2.0 or 3.0 drive; or portable external hard drive with USB 2.0 or 3.0 interfaces. (Contact HC at hc.ereview.sc@canada.ca for other media formats that may be acceptable at the time of filing.) A paper copy of the cover letter must accompany the media (unless otherwise indicated), and a pre-paid envelope must be provided if the media is to be returned. The complete regulatory transaction must be provided on a single drive, and the label on the drive should contain the following information:

  • Stakeholder Name
  • Brand Name
  • Dossier ID, which is based on the protocol number
  • Sequence (regulatory transaction) number

Media must be mailed to HC at the address below:

Health Canada
Finance Building
101 Tunney’s Pasture Driveway
Address Locator: 0201A1
Ottawa, Ontario
K1A 0K9

See the G-CESG, the G-eCTD, CAN-47, CAN-34, CAN-36, CAN-25, and CAN-28 for details on registering as a trading partner for CESG transactions, how to use CESG, and submitting CTAs in eCTD format. (Note: As per ElecSubms, G-CESG is only available upon request at no-reply.ereview.non-reponse@hc-sc.gc.ca. Please ensure the text 'Request for eCTD Guidance Document' is in the subject line of the email.)

Non-eCTD Electronic Submission

For non-eCTD electronic submissions, G-Non-eCTD indicates that HC requires both PDF and MS-Word formats for the CTA (CAN-4). The PDF documents must be generated from electronic sources (not scanned material), except when access to an electronic source document is unavailable or where a signature is required. It is important that PDF files be properly bookmarked and hyperlinked. Documents that legally require signatures may be signed with an electronic signature, or the signature page can be printed, signed, scanned, and saved as a PDF file. The cover letter does not require a signature, but should include a printed name, phone number, and email address. All regulatory submissions should be validated prior to transmitting to HC. For validation rules, see the Rules-Non-eCTD. The ElecSubms contains a zip file of the folder structure for clinical trial non-eCTD submissions. (Note: As per ElecSubms, G-Non-eCTD is only available upon request at no-reply.ereview.non-reponse@hc-sc.gc.ca. Please ensure the text 'non eCTD Guidance Document' is in the subject line of the email.)

Per the G-Non-eCTD, CTA submissions to the appropriate Directorate within HC’s HPFB must be in one (1) of these accepted media formats:

  • Compact Disc-Recordable (CD-R) conforming to the Joliet specification
  • USB 2.0 or 3.0 drive
  • Digital Versatile Disc (DVD-RAM and DVD+R/-R) in Universal Disk Format (UDF) standard

All media should be labelled and contain the following information:

  • Stakeholder Name
  • Brand Name
  • Dossier ID (if known)

Subsequent to burning the CD/DVD or transferring data to a drive, applicants should ensure that all files can be opened, files are not corrupted, and that "Thumb.db" files are removed.

As per the G-Non-eCTD, CAN-18, and CAN-17, non-eCTD CTAs involving pharmaceutical drugs should be sent to PDD, and CTAs involving biologics and/or radiopharmaceuticals should be sent to BRDD at the addresses listed below.

Office of Clinical Trials
Pharmaceutical Drugs Directorate
Health Canada
5th Floor, Holland Cross, Tower B
1600 Scott Street
Address Locator: 3105A
Ottawa, Ontario, Canada
K1A 0K9
General Inquiries E-mail: oct.enquiries-requetes.bec@hc-sc.gc.ca

Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
Ground Floor, Health Canada Building 6
100 Eglantine Driveway
Address Locator: 0601C
Ottawa, Ontario, Canada
K1A 0K9
General Enquiries E-mail: brdd.ora@hc-sc.gc.ca

Per the HCNotice-CTSIForm, questions related to pharmaceutical CTSI forms should be sent to: oct.enquiries-requetes.bec@hc-sc.gc.ca and questions related to biologic CTSI forms should be sent to brdd.ora@hc-sc.gc.ca.

Per the G-Non-eCTD, if an applicant submits a non-eCTD CTA via email, they should meet the following requirements:

  • The maximum email size accepted by the corporate mail server is 20 megabytes. If the clinical trial submission is larger than 20 megabytes, the submission may be split and sent as separate emails (e.g., an email for Module 1, and another email for Module 2/3). The subject line of the emails should clearly link to each other (e.g., "Email 1 of 2" in the relevant subject line)
  • A duplicate copy must not be provided by mail
  • The submission should be organized in folders and the body of the email should only contain the zipped regulatory submission
  • Zipped files and documents contained in the email should not be password protected

The G-Non-eCTD provides additional information on emailing other clinical trial submissions, including responses to a clarification request, responses to a no objection letter, notifications, and development safety update reports.

Ethics Review Submission

As indicated in the CanadaFDR and the G-CanadaCTApps, all research involving human participants in Canada must be reviewed by an institutional ethics committee (EC). (Note: institutional ECs are referred to as Research Ethics Boards (REBs) in Canada.) Because the submission process at individual institutional ECs will vary, applicants should review and follow their institution’s specific requirements. Further, Canadian provinces may have varying requirements, and, therefore, the sponsor should consult with the applicable province(s) for more information. See CAN-35 for submission requirements to the joint HC-Public Health Agency of Canada (PHAC)’s REB. This joint EC reviews all research involving human subjects that is carried out by HC or PHAC researchers, on the premises, or in collaboration with external researchers.

1.2, 2.2, 2.3, and 2.7
5.2, 5.4, and 5.5
3.1-3.4 and Appendix B
Guidance documents, notices, and supporting documents
7.1, 8.1, and 8.2
1.3 (Table 1), 3.2, and 5
Part C (Division 5 (C.05.002, C.05.004, C.05.005))
Last content review/update: February 9, 2024

Overview

According to the NDPA-CTReg, the G-CTConduct, the NGHRP, the G-UNCSTreg, and the G-TrialsGCP, institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approval, National Drug Authority (NDA) approval, and Uganda National Council for Science and Technology (UNCST) registration are mandatory before a study may commence.

Per the NDPA-CTReg and UGA-20, the NDA’s review and approval of a clinical trial application are dependent upon the applicant submitting proof in the application of institutional EC approval and a research permit from the UNCST. UGA-33 further notes that for clinical trials involving human participants, approval must be obtained through the institutional EC portal (the National Research Information Management System (NRIMS) (UGA-33)) before NDA approval. Therefore, the NDA and institutional EC reviews may not be conducted in parallel. However, the G-TrialsGCP indicates that parallel submissions may be made to the NDA and the UNCST. In that instance, the NDA would not make a final decision until after the trial receives UNCST clearance.

Regulatory Submission

National Drug Authority

According to the NDPA-CTReg, an application to the NDA for authorization to conduct a clinical trial is submitted by a sponsor, who must be one (1) of the following:

  • The drug patent holder
  • A licensed person (a pharmacist)
  • The drug manufacturer
  • An agent of the drug patent holder or the drug manufacturer

In those cases where an agent submits the clinical trial application, the agent must also submit a power of attorney verifying their appointment as an agent or a letter of authorization (See Form 30 in Schedule 1 of the NDPA-CTReg or UGA-18). Furthermore, the G-CTConduct indicates that based on the clinical trial agreement between the sponsor and the principal investigator (PI), the NDA will liaise with the in-country PI representing the sponsor regarding the application.

As per the G-CTConduct, the sponsor or authorized person should submit one (1) copy of the completed clinical trial application form for each application. The application must be bound in a single volume (or series of volumes), and the pages numbered sequentially. Appended documents should be bound together with the application, with tabbed sections clearly identifying each appended document. The text and diagrams must be clear and legible in 12 pt Times New Roman font. See Appendix I of the G-CTConduct for the clinical trial application form.

Per C-IncompleteCTA, incomplete submissions will not be received at the NDA registry. All submissions that are deemed incomplete will be returned with a checklist indicating the missing regulatory requirements.

According to the G-CTConduct, an application to conduct a clinical trial must be submitted to:

The Secretary to the Authority
National Drug Authority
P.O. Box 23096
Rumee Towers, Plot 19 Lumumba Avenue
Kampala, Uganda
Phone: (+256) 417 788 100 / 1 0417 799 124 0417 788 129
Fax: (+256) 41 255758 / 343921
Email:
ndaug@nda.or.ug; or clinicaltrials@nda.or.ug (per UGA-31)

As per the G-CTConduct, all applications and supporting data submitted to the NDA should be presented in English. Supporting documents that are not in English must be accompanied by an authenticated English translation.

The NDPA-CTReg further indicates that an application for deviation from a condition of a clinical trial must use Form 36, and an application for additional investigators, additional clinical trial sites, or for change of the investigators must use Form 37 (see Schedule 1 of the NDPA-CTReg).

Per the G-CTConduct, the application for amendment of the conditions of a clinical trial can also be found in Appendix III of the G-CTConduct, and on the NDA website at UGA-19. The proposed changes must be listed in a cover letter signed by the applicant. In the cover letter, a clear step-by-step justification for each proposed change(s) must be provided, and the possible consequences with regard to the benefit/risk balance for participants already enrolled in the trial must be summarized. The subject of the cover letter must be “Application to amend CTA XXX” where XXX is the Clinical Trial Application code assigned by the NDA upon authorization of the clinical trial and indicated on the clinical trial certificate. Only one (1) copy of the completed form must be sent to the NDA.

Uganda National Council for Science and Technology

Per the G-UNCSTreg, research protocols submitted to the UNCST for registration and approval must be well written and fully developed. Draft research protocols will not be accepted for registration. In order to register a research protocol, the PI should complete the necessary research application forms. Where a research protocol requires ethical approval by a foreign-based EC, it is advisable that such approval be obtained prior to submitting the protocol to the UNCST.

The online application for UNCST permission to conduct research in Uganda is provided in UGA-28.

UGA-20 also provides the following contact information for further information on the UNCST research clearance process:

Beth Mutumba
Phone: 0414 557 025/0755 423 321
Email:
b.mutumba@uncst.go.ug

Samuel Barasa
Phone: 0414 557 021/0779 452 441
Email:
s.barasa@uncst.go.ug

Ethics Review Submission

UGA-20 indicates that for EC submissions, the applicant should contact the accredited committee at their institution of affiliation or obtain contacts via the UNCST website. After identifying the appropriate EC, the applicant must create an account and fill out the application on UGA-33.

Per UGA-33, NRIMS is an online platform that supports the NDA, the Uganda National Health Research Organisation (UNHRO), the UNCST, and institutional ECs in the regulatory oversight of clinical research. The system provides researchers with an interface with the regulatory agencies in the data capture, data management, data validation, quality control, and overall regulatory compliance related to clinical research management processes. See UGA-33 for more information.

Each EC has its own required submission procedures, which can differ regarding the application format and number of copies.

Introduction, 4.2-4.3, 4.5-4.7, 7.1, and Appendices I and III
1.6-1.7
6.0 and 8.0
2.2 and 3.1-3.4
Part II (3-8 and 10) and Schedule 1 (Forms 29, 30, 36, and 37)

Submission Content

Last content review/update: October 1, 2024

Regulatory Authority Requirements

As set forth in the CanadaFDR, the G-CanadaCTApps, and CAN-31, Health Canada (HC) requires the sponsor to apply for clinical trial authorization by submitting a clinical trial application (CTA) to HC. As specified in the G-CanadaCTApps and the G-QCM-PharmCTAs, the CTA should be organized into three (3) modules in Common Technical Document (CTD) format:

  • Module 1 - Administrative and clinical information about the proposed trial
  • Module 2 - Quality (Chemistry and Manufacturing) summaries about the drug product(s) to be used in the proposed trial
  • Module 3 - Additional supporting quality information

Per the CanadaFDR, the clinical trial application form (CAN-4) and the following information and documents must be submitted:

  • Protocol
  • Summary of potential risks/benefits
  • Clinical trial attestation that includes drug information (chemistry, names, classifications, dosage, therapeutic purpose, human-sourced excipient, drug identification number or notice of compliance, manufacturing information); sponsor’s contact information; if the drug is to be imported, contact information for the sponsor’s representative in Canada who is responsible for the sale of the drug; and contact information for the qualified investigator at each site, if known at the time of submittal
  • Contact information for each institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) that approved the protocol, if known at the time of submitting the application
  • Contact information of any institutional EC that previously refused to approve the protocol, its reasons, and refusal date
  • Investigator’s Brochure (IB)
  • Informed consent form (ICF)
  • Information about use of a human-sourced excipient
  • Chemistry and manufacturing information
  • Proposed date for trial commencement at each site, if known

Refer to the CanadaFDR, the G-CanadaCTApps, the G-DrugApp, the G-QltyBioCTs, and the G-QCM-PharmCTAs for detailed submission information.

Ethics Committee Requirements

Each institutional EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies to be supplied and application format requirements. However, the following requirements comply with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, and are basically consistent across all Canadian ECs:

  • Clinical protocol
  • ICFs and participant information
  • Participant recruitment procedures
  • IB
  • Safety information
  • Participant payments and compensation
  • Investigator(s) current curriculum vitaes (CVs)
  • Additional required institutional EC documentation

See section 3.1.2 of CAN-52 for additional submission content requirements.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, requires clinical trial researchers to include a plan for monitoring safety, efficacy/effectiveness (where feasible), and validity in their proposal for EC review. See the G-TCPS2 for additional details on the plan’s required contents.

See CAN-35 for submission requirements to the joint HC-Public Health Agency of Canada (PHAC)'s REB. This joint EC reviews all research involving human subjects that is carried out by HC or PHAC researchers, on the premises, or in collaboration with external researchers.

Clinical Protocol

As delineated in CAN-52, the clinical protocol should include the following elements:

  • General information
  • Background information
  • Trial objectives and purpose
  • Trial design
  • Participation selection/withdrawal
  • Participant treatment
  • Efficacy assessment
  • Safety assessment
  • Statistics
  • Direct access to source data/documents
  • Quality control/quality assurance procedures
  • Ethical considerations
  • Data handling and record keeping
  • Financing and insurance
  • Publication policy
  • Supplements

For complete protocol requirements, see section 6 of CAN-52.

3.1.2, 6, and 7
Efficacy guidelines
Apply for Ethics Review
2.3 and 2.7
I, S Drug Substance, and P Drug Product
Chapter 11 (Article 11.6)
Part C (Division 5 (C.05.001, C.05.004, and C.05.005))
Last content review/update: February 9, 2024

Regulatory Authority Requirements

National Drug Authority

As per the G-CTConduct and UGA-1, the following documentation must be submitted to the National Drug Authority (NDA) in a clinical trial application (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

  • Proof of payment
  • Applications for import and/or export of biological materials (if required)
  • Clinical Trial Application Form (See Appendix I of the G-CTConduct)
  • Trial protocol
  • Investigator’s Brochure (See UGA-4 or Schedule 2 of the NDPA-CTReg)
  • Participant Information Leaflet and informed consent form
  • Certificate of Good Manufacturing Practice (GMP) of the trial medicine or other evidence of manufacturing quality, safety, and consistency
  • Package insert(s) for other trial medicines
  • Certificate of GMP of the placebo, if appropriate
  • Evidence of accreditation of the designated laboratories or other evidence of Good Laboratory Practice (GLP) and assay validation
  • Insurance certificate specific for the trial sourced from a local provider or in consultation with the NDA
  • Signed and completed declarations by all investigators (See UGA-16 or Form 31 in Schedule 1 of the NDPA-CTReg)
  • Approval of ethics committees (ECs) for the protocol
  • Uganda National Council for Science and Technology (UNCST) approval
  • Full, legible copies of key, peer-reviewed published articles supporting the application
  • Sample of the label for the investigational products (IPs)
  • Letter of authorization from the manufacturer/product owner (See UGA-18 or Form 30 in Schedule 1 of the NDPA-CTReg)
  • Pharmaceutical data on dosage form (See UGA-14 or Form 34 in Schedule 1 of the NDPA-CTReg)
  • Duly signed declaration of the monitor (See UGA-17 or Form 32 in Schedule 1 of the NDPA-CTReg)
  • Clinical trial agreement between the sponsor and the principal investigator (PI)
  • Duly signed declaration by the sponsor and PI of funds of the clinical trial (See UGA-15 or Form 33 in Schedule 1 of the NDPA-CTReg)
  • Other supporting documents

The C-InstitutionCert further indicates that clinical trial certificates will not be issued without submission of a valid certificate of suitability of the premises supplying drugs within the respective institutions.

As per the NDPA-CTReg, an application for deviation from a condition of a clinical trial must use Form 36, and an application for additional investigators, additional clinical trial sites, or for change of the investigators must use Form 37 (see Schedule 1 of the NDPA-CTReg).

According to the G-CTConduct, an application for amendment of the conditions of a clinical trial can also be found in Appendix III of the G-CTConduct and on the NDA website at UGA-19. The amendment application must be accompanied by a cover letter signed by the applicant together with required supporting documentation, including a submission of the protocol amendment in tracked changes, a clean copy clearly indicating the protocol version number, valid evidence of payment of amendment fees, and ethical approval of the proposed amendment. See the NDPA-CTReg, G-CTConduct, and UGA-19 for more detailed amendment application content requirements.

Uganda National Council for Science and Technology

As per UGA-20, the PI should have soft copies of the following documents ready before making an online submission through UGA-28 to the UNCST:

  • A letter of introduction or recommendation from the affiliated institution in Uganda (for foreign investigators only). The letter should mention the names of the foreign investigators and it should be addressed to the UNCST Executive Secretary
  • An administrative clearance letter from the head of the institution where the research is going to be conducted, addressed to the PI and/or the UNCST Executive Secretary
  • Admission letter for academic research (applies to only East African students)
  • Curriculum vitaes (CVs) for each investigator, dated and signed or initialed on each page
  • Proof of payment of research administration and clearance fees for the study

Additionally, a permit must be obtained from the UNCST to export and import plant or animal specimens for further investigations.

See UGA-20 for detailed application requirements.

Ethics Committee Requirements

According to UGA-20 and UGA-28, EC approval is obtained through the National Research Information Management System (NRIMS) (UGA-33).

The NGHRP further indicates that all ECs must develop detailed standard operating procedures for submission of protocols and other requirements. However, at a minimum, the requirements should include:

  • Research protocol with version and date
  • Informed consent documents
  • Study instruments such as questionnaires, case report forms, videos, flip charts, and any other data collection tools or forms
  • Samples of trial drugs
  • Evidence that the investigator(s) is appropriately qualified, experienced and, where applicable, licensed, and has adequate facilities for the safe and efficient conduct of research
  • A plan for disseminating research findings to the community in which the research was carried out, and other authorized agencies in Uganda

Clinical Protocol

As delineated in Schedule 2 of the NDPA-CTReg and UGA-12, the clinical protocol should contain the following information:

  • Product name and dosage form
  • Trial identification
  • Trial objective
  • Trial design
  • Trial participants
  • Treatment profile
  • Trial parameters
  • Operational aspects
  • Adverse event reporting methods
  • Evaluation of results
  • PI and co-investigator(s) names

For detailed information on these elements, please refer to the NDPA-CTReg and UGA-12.

4.6, 7.1, and Appendices I-V
4.8
Part II (10), Schedule 1 (Forms 29-34 and 36-37), and Schedule 2

Timeline of Review

Last content review/update: October 1, 2024

Overview

As delineated in the CanadaFDR and the G-CanadaCTApps, the review and approval of a clinical trial application (CTA) by Health Canada (HC) and an institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) may be conducted in parallel. However, per the CanadaFDR, the G-CanadaCTApps, CAN-6, and CAN-30, HC will not authorize the sponsor to begin the clinical trial until an institutional EC approval (provided in the required Clinical Trial Site Information (CTSI) form) for each participating trial site is submitted. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Regulatory Authority Approval

According to the CanadaFDR and the G-CanadaCTApps, an authorized clinical trial is one that has been filed with HC and has not received an objection within 30 days. All CTAs are subject to the 30-day default period from the date of receipt of the completed application at the appropriate Directorate within HC’s Health Products and Food Branch (HPFB). While the Directorates can establish shorter administrative targets of seven (7) days for the review of bioequivalence trials, the 30-day default system remains the regulatory requirement. Applications to conduct Phase I clinical trials using somatic cell therapies, xenografts, gene therapies, prophylactic vaccines, or reproductive and genetic technologies are not included in the seven-day target system. Please see the G-CanadaCTApps for special requirements regarding reviews of comparative bioavailability studies and joint reviews of clinical trials covering a combination of devices, biologics, and pharmaceuticals.

As specified in the G-CanadaCTApps and the G-MDSA, during the review period, the Directorate may request additional information from the sponsor, who has two (2) calendar days to provide such information. The G-MDSA clarifies that, where warranted, HC can adjust the timelines to be longer or shorter based on the complexity of the request, dialogue with the sponsor, and/or circumstances of the review, including pausing the clock during the scientific review. According to the G-CanadaCTApps and the G-MDSA, if HC authorizes the CTA, then it issues a No Objection Letter (NOL). If HC rejects the CTA, it sends a Not Satisfactory Notice (NSN). HC will issue an NSN if it identifies significant deficiencies, or, if a timely response to requested information has not been provided. The sponsor may resubmit the information and material at a future time, and it will be processed as a new CTA.

Ethics Committee Approval

The EC review and approval process timeline varies by institution. However, according to the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the institutional EC should review a proposed clinical trial within a reasonable time. The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, recommends a proportionate approach to ethics review—the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). In either case, pursuant to the G-TCPS2, the institutional EC should make its decisions in an efficient and timely manner. See CAN-35 for ethics review timelines with the joint HC-Public Health Agency of Canada (PHAC)'s REB. This joint EC reviews all research involving human subjects that is carried out by HC or PHAC researchers, on the premises, or in collaboration with external researchers.

3.1.2
Efficacy guidelines
Apply for Ethics Review
2.1, 2.3.3, 2.5, and 2.7
5.5 and 5.6
Chapter 2 (Articles 2.8 and 2.9) and Chapter 6 (Article 6.13)
11.1, 12.1, and 13.3-13.4
Part C (Division 5 (C.05.005 and C.05.006))
Last content review/update: July 10, 2024

Overview

Per the NDPA-CTReg and UGA-20, the National Drug Authority (NDA)’s review and approval of a clinical trial application are dependent upon the applicant submitting proof in the application of institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approval and a research permit from the Uganda National Council for Science and Technology (UNCST). UGA-33 further notes that for clinical trials involving human participants, approval must be obtained through the institutional EC portal (the National Research Information Management System (NRIMS) (UGA-33)) before NDA approval. Therefore, the NDA and institutional EC reviews may not be conducted in parallel. However, the G-TrialsGCP indicates that parallel submissions may be made to the NDA and the UNCST. In that instance, the NDA would not make a final decision until after the trial receives ethical clearance.

Regulatory Authority Approval

National Drug Authority

Per the G-CTConduct, NDA reviews for clinical trials are performed following a first-in first-out principle, except for clinical trials conducted in public health emergencies such as disease outbreaks, which may be exempted.

According to UGA-24, the NDA will screen and acknowledge receipt of a clinical trial application within 10 working days, and reach a decision on the application within 50 working days. (The G-CTConduct further indicates that expedited review, under which a regulatory decision is given to the applicant within 30 working days, is applicable for certain clinical trial applications. See the Scope of Assessment section for more information.)

The G-CTConduct states that the NDA may request supplementary information or documentation when appropriate, which should be submitted within the stated timeline, usually four (4) weeks. The NDA secretariat may grant additional time to provide information upon request by the applicant on a case-by-case basis. If the requested information is not submitted, the application will be archived within 50 working days. The application will need to be resubmitted for review. If the NDA, on its own initiative, makes amendments to the conditions for conducting a clinical trial for safety reasons or the scientific validity of the clinical trial, the NDA will give 15 calendar days’ notice to the sponsor or the principal investigator (PI) and request submittal of a written response to the proposed amendments.

Additionally, according to UGA-24, the NDA conducts annual reviews of ongoing trials within 20 working days and reviews amendments of clinical trial authorization within 20 working days. Per the G-CTConduct, the NDA review timelines published on UGA-24 do not include the time taken by the applicant to respond to any NDA requests for additional information. A stop-clock mechanism is applied each time the NDA requests additional information.

Uganda National Council for Science and Technology

The G-UNCSTreg states that the UNCST provides feedback on the registration status of a protocol within 10 working days from the submission date. According to the NGHRP, the UNCST registration process is normally completed within 14 working days.

Ethics Committee Approval

Per the G-TrialsGCP, an applicant must also submit the clinical trial protocol for review and approval by a UNCST-accredited institutional EC. As indicated in the NGHRP, the EC is required to review a clinical protocol within 60 days from the date of its receipt. In the case of an annual continuing review, the EC should maintain the same anniversary date of approval for any given protocol. Review outcomes must be communicated to the applicant within 14 days of the EC’s review.

5.0, 5.3-5.5, and 7.0
3.2 and 4.9
6.0
1.6 and 2.2
Part II (3-8)

Initiation, Agreements & Registration

Last content review/update: October 1, 2024

Overview

In accordance with the CanadaFDR and the G-CanadaCTApps, a clinical trial can only commence after the sponsor receives authorization from both Health Canada (HC) and an institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada). No waiting period is required following the applicant’s receipt of these approvals. CAN-30 specifies that for purposes of the Clinical Trial Site Information (CTSI) Form (CAN-6), the trial commencement date is the date when the clinical trial site is ready to enroll participants. The commencement date is a date after which the sponsor has both the HC authorization from the appropriate Directorate (date on the No Objection Letter (NOL)) and approval from the relevant EC. Further, the commencement date would be the date when the sponsor implements the protocol, which includes the screening period that occurs prior to the check-in date. See the Scope of Review section for detailed institutional EC requirements, and the Submission Content section for additional HC approval information. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

In addition, per the G-CanadaCTApps, if a sponsor (Canadian or foreign) wants to import a drug into Canada to conduct a clinical trial, a copy of HC’s clinical trial authorization (i.e., the NOL) must be included with the drug shipment. According to the G-CanadaCTApps and CAN-32, if a sponsor plans to import investigational drugs directly to each trial site, then the sponsor must also authorize the importer (i.e., the clinical trial site) when submitting the clinical trial application using Appendix I of HC’s Drug Submission Application Form (CAN-4). See the Manufacturing & Import section for detailed import requirements.

Clinical Trial Agreement

Prior to initiating the trial, as delineated in the G-FDR-0100 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor must sign an agreement between all involved parties, including ECs, Qualified Investigators (QIs), contract research organizations, and others, to ensure full compliance with the regulatory requirements. Further, the sponsor should obtain the investigator’s/institution's agreement:

  • To conduct the trial in compliance with good clinical practice, with the applicable regulatory requirement(s), and with the protocol agreed to by the sponsor and given approval/favorable opinion by the EC
  • To comply with procedures for data recording and reporting
  • To permit monitoring, auditing, and inspection
  • To retain the trial-related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

In accordance with the G-CanadaCTApps, prior to initiating a clinical trial, the sponsor must ensure that a Qualified Investigator Undertaking (QIU) form (CAN-37 or similar documentation that meets the CanadaFDR requirements) has been completed and is kept on file by the sponsor. Per the CanadaFDR, the form certifies that the QI will conduct the clinical trial in accordance with good clinical practice and will immediately inform trial participants and the institutional EC of trial discontinuance and the reason for this discontinuance. If there is a change in the QI at a site, a new CTSI Form must be submitted to HC, and a new QIU form must be maintained by the sponsor.

See CAN-6, CAN-8, and CAN-19 for additional clinical trial forms.

Clinical Trial Registration

As per the G-CanadaCTApps, sponsors should register their clinical trials on one (1) of two (2) publicly accessible registries accepting international clinical trial information and recognized by the World Health Organization (WHO), ClinicalTrials.gov (CAN-45), and the International Standardized Randomized Controlled Trial Number (ISRCTN) Registry (CAN-46). According to HCNotice-CTRegDisc, clinical trial registration is not a mandatory requirement at this time. However, per the G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, clinical trials must be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the WHO or the International Committee of Medical Journal Editors (ICMJE). In addition, following registration, researchers are responsible for ensuring that the registry is updated in a timely manner with: new information; safety and, where feasible, efficacy reports; reasons for stopping a trial early; and the location of findings.

1.17, 5.1.2, 5.6.3, and 8.2.6
Efficacy guidelines
1.2 and 2.7
5.6
Chapter 11 (Articles 11.10-11.11)
Part C (Division 5 (C.05.006))
Last content review/update: February 9, 2024

Overview

According to the NDPA-CTReg, the G-CTConduct, the NGHRP, the G-UNCSTreg, and the G-TrialsGCP, institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approval, National Drug Authority (NDA) approval, and Uganda National Council for Science and Technology (UNCST) registration are mandatory before a study may commence.

As per the NGHRP and the UNHRO-Act, the UNCST also works in collaboration with the Uganda National Health Research Organisation (UNHRO) to register all health research protocols. However, the registration is conducted centrally at the UNCST.

The G-CTConduct and the NDPA-CTReg indicate that following the NDA’s approval of the clinical trial application, the applicant is also required to obtain a permit from the NDA to import investigational products (IPs) approved for the clinical trial. See the Manufacturing & Import topic for more information on IP import permit requirements.

Per the NGCER, community engagement is an opportunity for communities to participate in the design and conduct of research, and enhances the relevance, ownership, and applicability of research findings. See the NGCER for UNCST guidance on how to ensure community engagement, as a way to improve responsiveness to community needs and accountability in research.

Clinical Trial Agreement

As delineated in the NDPA-CTReg and the G-CTConduct, before the trial begins, the sponsor must sign a clinical trial agreement with the principal investigator (PI).

According to the G-TrialsGCP, if the sponsor decides to use a contract research organization (CRO) to conduct the trial, the transferred duties should be specified in writing and evidence of a mutual agreement must be provided. The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities. A signed agreement between involved parties (such as the PI/institution and sponsor; the PI/institution and CRO; and the sponsor and CRO), is considered an essential document before a clinical trial can commence.

Per the G-TrialsGCP, the sponsor should obtain the investigator's agreement to:

  • Conduct the trial in compliance with the G-TrialsGCP, the principles of good clinical practice (GCP), the requirements of the NDA, and the protocol agreed upon by the sponsor and given approval by the relevant EC
  • Comply with procedures for data recording/reporting
  • Permit monitoring, auditing, and inspection
  • Retain the trial-related essential documents until the sponsor informs the investigator/institution that these documents are no longer needed

Clinical Trial Registration

The G-CTConduct states that clinical trial registration with a publicly accessible clinical trial registry is a requirement for all industry-funded trials in Uganda. Details of registration should be provided with the clinical trial application.

Introduction, 4.3, 4.6, 4.8, 10.0-10.1, and Appendix I
3.1-3.4, and 4.8
6.0-7.0
1.6-1.7, 4.4-4.5, 4.9, 6.10, and 10.3
Part II
Part II (3-9) and Schedule 1 (Form 29)

Safety Reporting

Last content review/update: October 1, 2024

Safety Reporting Definitions

According to the CanadaFDR and G-CanadaCTApps, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), the following definitions provide a basis for a common understanding of Canada’s safety reporting requirements:

  • Adverse Event (AE) – Any adverse occurrence in the health of a clinical trial subject who is administered a drug that may or may not be caused by the administration of the drug, and includes an adverse drug reaction.
  • Adverse Drug Reaction (ADR) – Any noxious and unintended response to a drug that is caused by the administration of any dose of the drug.
  • Serious Adverse Drug Reaction (SADR) or Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or causes a congenital anomaly/birth defect.
  • Serious, Unexpected ADR – A serious ADR that is not identified in nature, severity, or frequency in the risk information set out in the investigator’s brochure or on the label of the drug.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ethics committees (ECs), requires researchers to promptly report new information revealed during the conduct of the trial that might affect the welfare or consent of participants to the EC, to a publicly accessible registry, and to other appropriate regulatory or advisory bodies. In addition, when new information is relevant to participants’ welfare, researchers must promptly inform all participants to whom the information applies (including former participants). Researchers must work with their ECs to determine which participants must be informed, and how the information should be conveyed.

For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Safety Reporting Requirements

Investigator Responsibilities

Per CAN-52, which Canada has implemented per CAN-50, all SAEs should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify participants by unique code numbers assigned to the trial subjects rather than by their names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious ADRs to the regulatory authority(ies) and the EC. AEs and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol. For reported deaths, the investigator should supply the sponsor and the EC with any additional requested information (e.g., autopsy reports and terminal medical reports).

Sponsor Responsibilities

As delineated in the CanadaFDR, the G-CanadaCTApps, and CAN-22, the sponsor is required to expedite reports of ADRs to HC that meet these three (3) criteria: serious, unexpected, and having a suspected causal relationship. ADR reports that are expected or unexpected, but not serious, should not be reported to HC, but rather monitored and tracked by the sponsor. Further detail and clarifications on AE/ADR reporting criteria can be found in CAN-22. As specified in the G-CanadaCTApps, when evaluating whether an AE is serious and unexpected, the Qualified Investigator’s (QI) and sponsor’s determination of causality is important. Only serious and unexpected ADRs found to have a reasonable suspected causal relationship to the drug should be reported by the sponsor to HC.

Per the CanadaFDR and the G-CanadaCTApps, during a clinical trial, the sponsor is required to inform HC of any serious, unexpected ADR that has occurred inside or outside Canada. An ADR report must be filed in the following specified timelines:

  • When the ADR is neither fatal nor life-threatening, within 15 days after becoming aware of the information
  • When it is fatal or life-threatening, immediately when possible and, in any event, within seven (7) days after becoming aware of the information
  • Within eight (8) days after having informed HC of the ADR, submit a report that includes an assessment of the importance and implication of any findings

Other Safety Reports

The G-DSUR delineates that the development safety update report (DSUR) and the DSUR Checklist (CAN-38) should be provided when requested by HC. A DSUR may be submitted voluntarily to HC when important new safety information on a drug needs to be conveyed by a clinical trial sponsor. In these cases, a rationale/justification for the filing of the DSUR should be included in the cover letter. For additional details, see the G-DSUR.

The G-DSUR-CanUK describes the region-specific requirements for DSURs submitted to the regulatory authorities of Canada and the United Kingdom. This guidance applies to both marketed and non-marketed drugs that are used in clinical trials and applies to DSURs prepared by the manufacturer and/or marketing authorization holder of the investigational drug.

Form Completion & Delivery Requirements

As per the G-CanadaCTApps and CAN-22, all serious and unexpected ADRs should be reported individually to HC. According to CAN-48 (which Canada adopted pursuant to CAN-50), at a minimum, the report should include an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. The G-CanadaCTApps requires the sponsor to complete the expedited reporting form (CAN-5) and the CIOMS Form I (CAN-7) and fax them to the appropriate HC Directorate: BRDD Fax: 613-957-0364; PDD Fax: 613-941-2121.

Additionally, the G-DSUR indicates that HC recommends that DSURs in electronic Common Technical Document (eCTD) format be submitted via the Common Electronic Submission Gateway (CESG). For information on eCTD format, refer to the ElecSubms. For technical questions on eCTD filings, contact ereview@hc-sc.gc.ca as instructed in the G-DSUR.

1.1, 1.2, 1.50, 1.60, and 4.11
Efficacy guidelines
Notice, 1.2, and 2.4
2.1 and 2.8
5.14
Chapter 11 (Article 11.8)
Part C (Division 5 (C.05.001 and C.05.014))
Last content review/update: February 9, 2024

Safety Reporting Definitions

In accordance with the NDPA-CTReg, the NDPA-PVReg, the NDPA-PVRegAmdt, the G-CTConduct, the NGHRP, and the G-TrialsGCP, the following definitions provide a basis for a common understanding of Uganda’s safety reporting requirements:

  • Adverse Event (AE) – Any untoward medical occurrence in a research participant who is administered an investigational product (IP), and which does not necessarily have a causal relationship with this treatment
  • Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose
  • Serious Adverse Event (SAE)/Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in a congenital anomaly/birth defect
  • Unexpected Adverse Drug Reaction – An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved IP)

Safety Reporting Requirements

Investigator Responsibilities

As per the NDPA-CTReg and the G-TrialsGCP, the principal investigator (PI) must report all SAEs/SADRs to the sponsor within 48 hours of first knowledge. The report should identify each participant by an assigned number. When the SAE/SADR results in the participant’s death, the PI should supply the sponsor, the National Drug Authority (NDA), and the institutional ethics committee (EC) (research ethics committee (REC) in Uganda) with any additional information requested.

The NGHRP states that the PI is required to report to the EC no later than seven (7) calendar days upon receiving notice of an SAE/SADR. A detailed report of the SAE/SADR should be submitted within seven (7) calendar days from the date it is reported to the EC. All other AEs should be reported by the PI to the EC as soon as possible, but no later than 14 calendar days.

The G-TrialsGCP and the G-CTConduct further indicate that the PI is also required to report to the NDA no later than seven (7) calendar days upon receiving notice of an SAE/SADR. The initial reports to the NDA should be followed promptly by detailed, written follow-up reports after investigations have been completed, no later than 15 calendar days of becoming aware of the event.

Sponsor Responsibilities

According to the G-TrialsGCP, the sponsor is responsible for the ongoing safety evaluation of the IP(s). The sponsor should promptly notify all concerned investigator(s), the NDA, and the EC in writing of findings that could adversely affect the safety of participants, impact the conduct of the trial, or alter the EC's approval to continue the trial. Study participants should also be informed of any new information that could adversely affect their safety.

The NDPA-CTReg and the G-TrialsGCP state that the sponsor should keep detailed records of the trial-related AEs/ADRs reported by the PI.

In addition, according to the G-TrialsGCP, the sponsor should expedite the reporting of all AEs/ADRs that are both serious and unexpected to all concerned investigator(s)/institutions(s), EC(s), and to the NDA. The expedited reporting should occur within the timeframe and format specified by the NDA. Serious and unexpected AEs/ADRs suspected to be related to the IP(s) should be reported to the relevant EC as soon as possible. If the study is multicenter, the sponsor should ensure that all serious and unexpected AEs/ADRs that occur in other study sites are also reported within 15 calendar days of becoming aware of them.

As set forth in the NDPA-CTReg, the sponsor and the PI must also take appropriate safety measures to protect participants against any immediate hazards to their health and safety. When safety measures are taken, the sponsor should provide written notice to the NDA within three (3) working days of this action and the reasons why this action was taken.

Reporting Requirements for SUSARs

As set forth in the NDPA-CTReg, the PI should record and report to the sponsor any suspected unexpected serious adverse reaction (SUSAR) that occurs during the course of trial. In turn, the sponsor should report any SUSARs within seven (7) days of first knowledge to the NDA and the Uganda National Council for Science and Technology (UNCST), or a UNCST-accredited EC.

However, the G-TrialsGCP indicates that the sponsor should report any SUSARs to the NDA within 15 calendar days of becoming aware of the event. The initial reports should be followed promptly by detailed, written follow-up reports after investigations have been completed, no later than 15 calendar days of becoming aware of the event.

According to the NDPA-CTReg and the G-TrialsGCP, the sponsor should also inform the PI of any SUSARs which occur during the course of another trial for which the sponsor is responsible, where the reaction relates to the IP used in the trial. The NDA should maintain a record of all IP-related SUSARs reported to the authority.

Form Completion & Delivery Requirements

Per UGA-31, the NDA has stated that it does not have a template for reporting AEs for clinical trials. The NDA recommends the use of internationally acceptable forms, such as the one provided by the Council for International Organizations of Medical Sciences (CIOMS) (UGA-8).

2.0 and 9.1
1.1, 3.4, 3.13, and 4.18-4.19
7.1-7.2 and 9.1-9.4
Part I (2), Part III (18-19), and Part IV (21-22)
2-3, 6, and Schedule (Format of Report on Suspected Adverse Drug Reactions for Human Drugs)

Progress Reporting

Last content review/update: October 1, 2024

Interim and Annual Progress Reports

Pursuant to the CanadaFDR, the G-CanadaCTApps, CAN-22, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), investigators and sponsors share responsibility for submitting interim and annual reports on the status of a clinical trial. The investigator is required to provide annual progress reports to the institutional ethics committee (EC) and submit interim progress reports to the EC and Health Canada (HC) if there are any significant changes affecting the trial or risk to participants. The sponsor is required to submit annual reports (in the form of an updated Investigator’s Brochure (IB)) to HC. Note that per CAN-50, HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

As per CAN-52, which Canada has implemented per CAN-50, the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

According to the G-TCPS2, investigators must report new information that may affect the welfare or consent of participants to the institutional EC, HC, and other appropriate regulatory or advisory entities. When new information is relevant to participants’ welfare, researchers must promptly inform all participants to whom the information applies (including former participants). Researchers should work with their ECs to determine which participants must be informed, and how the information should be conveyed. New information may comprise a range of issues, including, but not limited to:

  • Changes to the research design
  • Evidence of any new risks
  • Unanticipated issues that have possible health or safety consequences for participants
  • New information that decisively proves the benefits of one (1) intervention over another
  • New research findings, including relevant non-trial findings
  • Unanticipated problems
  • Closure of trials at other sites for reasons that may be relevant to the welfare or consent of participants in the ongoing trial

Pursuant to CAN-52, the investigator should submit written summaries of the trial status to the institutional EC annually, or more frequently, if requested.

Final Report

Upon completion of the trial, as delineated in CAN-52, the investigator is required to submit a final report to the institutional EC summarizing the trial’s outcome. The CanadaFDR does not require submission of a final study report to HC.

Per the G-CanadaCTApps, the sponsor should notify the HC Directorate when a clinical trial is completed or a clinical trial site is closed. A study is considered to be completed after the last participant globally completes the "end of study" visit as defined in the protocol. The "end of study visit" is the final visit for study-related tests and procedures, including the capture of any final potential study-related adverse events, and usually occurs after the participant has completed/discontinued study drug administration. The "end of study visit" is normally an in-person visit, but for some studies it can also be carried out over the telephone. There may be certain scenarios (e.g., gene therapies, drugs with very long half-lives) where a study may be considered to be ongoing well beyond the period of study treatment, i.e., where long-term safety monitoring and reporting would be required. The reporting requirements with regards to such long-term follow-up of safety are normally specified in the study protocol and agreed to between the sponsor and HC prior to the authorization of the clinical trial in Canada.

4.10 and 4.13
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
2.8
5.12 and 5.13
Chapter 11 (Article 11.8)
Part C (Division 5 (C.05.012 and C.05.013))
Last content review/update: February 9, 2024

Interim and Annual Progress Reports

As per the G-TrialsGCP, the principal investigator (PI) is obliged to submit progress reports as required by the sponsor, the institutional ethics committees (ECs) (research ethics committees (RECs) in Uganda), the Uganda National Council for Science and Technology (UNCST), and the National Drug Authority (NDA). These reports should contain information on:

  • How the study is progressing
  • The number of participants included in relation to the number screened and the target sample size
  • The number of dropouts and withdrawals
  • Adverse events
  • If the planned time schedule is still appropriate

The format and frequency of reporting is as prescribed by the relevant authorities.

The NDPA-CTReg and the G-CTConduct also state that the NDA may request the sponsor to submit an interim report.

Additionally, per the G-UNCSTreg, although annual renewal of a study is not required, investigators should electronically submit annual progress reports to the UNCST within four (4) weeks following every 12 months of the study for informational purposes only. Failure to do so may result in termination of the research.

See Schedule 2 of the NDPA-CTReg or UGA-6 for the format of the clinical trial report.

Final Report

The NGHRP states that the sponsor is responsible for approving a final study report, regardless of whether the trial has been completed. In addition, the NDPA-CTReg and the G-TrialsGCP require the sponsor to inform the NDA in writing of the conclusion of the trial within 90 days.

However, the G-TrialsGCP further indicates that upon completion of the trial, the investigator, where applicable, should inform the institution. The investigator/institution should provide the EC with a summary of the trial’s outcome and furnish the regulatory authorities with any reports required. All aspects (statistical and clinical) of the protocol should be integrated in order to obtain a final study report that is entirely consistent with the study data generated. Essential elements in the presentation of the results include:

  • Baseline comparisons between the treatment groups
  • The number of participants actually randomized into the study by treatment group and the number of participants excluded from any of the analyses, by reason and by treatment group
  • Major efficacy and safety results by treatment group in the form of tables, graphs, test variables, and statistical parameters, as appropriate
  • An assessment of between-group differences with confidence intervals

An account must be made of missing, unused, or spurious data during statistical analyses. All omissions of this type must be documented to enable review.

In accordance with the G-UNCSTreg, it is the investigator’s obligation to submit final reports of the research projects to the UNCST. Investigators are free to adopt any format for writing a final report, but the report should have an abstract, a results section, a discussion of the results, and recommendations. Investigators who are foreign nationals are required to submit a study completion report before returning to their countries.

9.4-9.5
1.7, 3.15, and 5.2
14.1 and 14.4
7.2
Part II (12) and Schedule 2 (Format for the Clinical Trial Report)

Definition of Sponsor

Last content review/update: October 1, 2024

As per the CanadaFDR and the G-CanadaCTApps, a sponsor is defined as an individual, corporate body, institution, or organization that conducts a clinical trial. The International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, expands on this definition to include individuals, companies, institutions, or organizations that take responsibility for the initiation, management, and/or financing of a clinical trial.

In accordance with CAN-52, Canada also permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

According to the CanadaFDR and G-CanadaCTApps, a sponsor may be domestic or foreign. A foreign sponsor is required to have a senior medical or scientific officer who is residing in Canada who will represent the sponsor, and sign and date the application and the clinical trial attestation form.

For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

1.53, 5.1, and 5.2
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
2.1
5.1 and 5.5
Part C (Division 5 (C.05.001, C.05.005, C.05.015))
Last content review/update: February 9, 2024

As defined in the NDPA-CTReg, the G-CTConduct, the G-GMPMedicinalAnnexes, and the G-TrialsGCP, a sponsor is the person, company, institution, or organization that takes responsibility for the initiation, management, or financing of a clinical trial. The NGHRP specifically assigns responsibility to the sponsor for providing all the necessary financial support to initiate and complete a research study.

The NDPA-CTReg also specifies that in order to submit a clinical trial application, the sponsor must be one of the following:

  • The drug patent holder
  • A licensed person (a pharmacist)
  • The drug manufacturer
  • An agent of the drug patent holder or the drug manufacturer

As stated in the G-TrialsGCP, a sponsor may transfer any or all of the sponsor's trial-related duties and functions to a contract research organization (CRO), but the ultimate responsibility for the quality and integrity of the trial data always rests with the sponsor. The CRO must have the required skills, experience, and competencies to safely conduct clinical trials. Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing and evidence of a mutual agreement provided. The sponsor should ensure oversight of any trial-related duties and functions carried out on the sponsor’s behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s). Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.

Per the NDPA-CTReg, a local company in Uganda may act as an agent in the clinical trial for a foreign sponsor.

2.0
Annex 13 (Glossary to Annex 13)
1.1 and 4.5
7.2
Part I (2), Part II (4), and Schedule 1 (Form 30)

Site/Investigator Selection

Last content review/update: October 1, 2024

Overview

As set forth in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor should select the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s). Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

In accordance with the G-CanadaCTApps, prior to initiating a clinical trial, the sponsor must ensure that a Qualified Investigator Undertaking (QIU) form (CAN-37) (or similar documentation that meets the CanadaFDR requirements) has been completed and kept on file by the sponsor; it should be retained by the sponsor for 15 years. Per the CanadaFDR, the form certifies that the qualified investigator will conduct the clinical trial in accordance with good clinical practice, and will immediately inform trial participants and the institutional ethics committee (EC) (known as Research Ethics Boards in Canada) of trial discontinuance, and the reason for this discontinuance. (See the Submission Content section for additional information on clinical trial application requirements). For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Per CAN-11, the Canadian Clinical Trials Asset Map (CCTAM) (CAN-26) is a pan-Canadian research inventory of investigators, clinical research sites, and other resources across the country. Sponsors can use CCTAM to identify potential sites and investigators, which may expedite study feasibility and start-up timelines. To view the CCTAM, the user must register and create an account.

Foreign Sponsor Responsibilities

According to the CanadaFDR and the G-CanadaCTApps, a sponsor may be domestic or foreign. A foreign sponsor is required to have a senior medical or scientific officer residing in Canada to represent the sponsor, and sign and date the application and the clinical trial attestation form.

Data and Safety Monitoring Board

Although not specified as a sponsor requirement, CAN-52 states that a Data and Safety Monitoring Board (DSMB) (known as an Independent Data-Monitoring Committee in Canada) may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

The G-TCPS2 provides the following considerations to help researchers and ECs determine whether a DSMB is needed:

  • The magnitude of foreseeable research-attributable harms to participants
  • Whether the circumstances of the participants make them vulnerable in the context of research
  • The feasibility of interim data analysis
  • The complexity of the study
  • Conflicts of interest

Multicenter Studies

Per CAN-52, if a multicenter trial will be conducted, the sponsor must organize a coordinating committee or select coordinating investigators. In addition, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by HC
  • The EC has given approval to the protocol
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, on complying with a uniform set of standards to assess clinical and laboratory findings, and on completing the CRFs
  • Communication between investigators is facilitated

The CanadaFDR and the G-CanadaCTApps, require the sponsor to complete and retain the Research Ethics Board (REB) Attestation (CAN-8) and Qualified Investigator Undertaking (QIU) (CAN-37) forms at each trial site, while submitting in electronic format the Clinical Trial Site Information Form (CAN-6) to the appropriate HC Directorate for each trial site.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, provides that in multi-site clinical trials, a lead principal investigator (PI) is a designated PI who is responsible for the ethical conduct of the study for all sites. The lead PI is responsible for communicating any changes to the study, new information, and/or unanticipated events to the EC, to the sponsor, and to local site PIs.

Per CAN-50, Canada has implemented the ICH Guidance E17: Multi-Regional Clinical Trials (CAN-40), which describes general principles for the planning and design of multi-regional clinical trials with the aim of increasing the acceptability of these trials in global regulatory submissions. HC recognizes that the scope and subject matter of current HC guidance may not be entirely consistent with ICH guidance. In such circumstances, HC-implemented ICH guidance takes precedence.

1.25, 5.5, 5.6, and 5.23
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Canadian Clinical Trials Asset Map
2.1 and 2.7.2
5.5
Chapter 11 (Article 11.7)
Part C (Division 5 (C.05.005))
Last content review/update: February 9, 2024

Overview

As per the NDPA-CTReg and the G-TrialsGCP, the sponsor oversees the selection of the investigator(s) and the institution(s) for the clinical trial. The G-CTConduct indicates that based on the clinical trial agreement between the sponsor and the principal investigator (PI), the National Drug Authority (NDA) will liaise with the in-country PI representing the sponsor regarding the application. The PI should be a Ugandan resident and licensed by a relevant body in Uganda.

The G-TrialsGCP states that before entering an agreement with an investigator to conduct a trial, the sponsor should provide the investigator with the protocol and an up-to-date Investigator's Brochure (IB). The investigator should also be given sufficient time to review the protocol and the information provided. The PI/investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, meet all the qualifications specified by the applicable regulatory requirement(s), and provide evidence of such qualifications through an up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the accredited institutional ethics committee (EC) (research ethics committee (REC) in Uganda), and/or the NDA. The PI/investigator(s) should also be thoroughly familiar with the appropriate use of the investigational product(s) (IP(s)), as described in the protocol, current IB, product information, and other information sources provided by the sponsor. Furthermore, the PI/investigator(s) should be aware of, and comply with, good clinical practice (GCP) and the applicable regulatory requirements.

According to the NDPA-CTReg, an application for additional investigators, additional clinical trial sites, or investigator changes must be made using Form 37 in Schedule 1 of the NDPA-CTReg or UGA-13 and must be accompanied by evidence of ethical approval of the clinical trial protocol amendment, where applicable, and the prescribed fees.

In accordance with the G-UNCSTreg, all investigators who are foreign nationals are required to identify and become affiliated with a local organization appropriate for their type of research in Uganda. Investigators arrange the affiliation themselves with the local organization. The investigator should obtain a letter of recommendation from the local organization and submit it to the Uganda National Council for Science and Technology (UNCST).

Foreign Sponsor Responsibilities

The NDPA-CTReg states that in the case of foreign sponsors, a local company in Uganda must submit a letter of authorization from the holder of the patent of the drug, licensed person, or manufacturer of the drug to be the agent in the clinical trial that is responsible for all matters pertaining to the NDA clinical trial certificate. See Form 30 in Schedule 1 of the NDPA-CTReg or UGA-18 for the letter of authorization, and Form 35 in Schedule 1 of the NDPA-CTReg, as amended by the NDPA-CTRegAmdt, for the clinical trial certificate.

Data and Safety Monitoring Board

According to the NGHRP, the G-TrialsGCP, and the NDPA-CTReg, the sponsor is responsible for establishing a Data and Safety Monitoring Board (DSMB) (also referred to as an Independent Data-Monitoring Committee (IDMC)) prior to the trial’s commencement. Per the NGHRP, the DSMB ensures that the study and the data are handled in accordance with the protocol provisions, monitors adverse events/adverse drug reactions and safety data, and preserves the integrity and credibility of the trial. The composition of the DSMB must be provided to the EC. All Phase I, Phase II, and Phase III trials must have a safety monitoring plan and a DSMB. For additional details on DSMB requirements, see 3.6.2 of the NGHRP.

The G-TrialsGCP further indicates that a DSMB should have written operating procedures and maintain written records of all its meetings. A duly signed DSMB charter must be submitted to the NDA prior to recruitment of participants, and any decision not to create a DSMB should be clearly documented and justified in the protocol.

Multicenter Studies

The G-TrialsGCP indicates that multicenter trials must adhere to all national regulatory requirements, ensuring consideration and adaptation of the local context into the general study design. The following should be considered regarding multicenter trials:

  • Inclusion and exclusion criteria must be appropriate to consider local realities, as well as trial site-specific differences
  • The informed consent procedure must be tailored to local conditions and informed consent forms translated into the local language submitted to the EC for approval
  • Study design differences between the Ugandan site(s) and other sites must be fully explained, as well as differences between sites within Uganda. Study extrapolations and conclusions should be relevant to the Ugandan context
  • Where necessary, site investigators should develop site-specific standard operating procedures and/or a site implementation plan to guide the respective sites on protocol implementation

Per the G-TrialsGCP, for multicenter trials, the PI is responsible for appointing co-investigators that will be responsible for the various trial sites in Uganda. However, it is the responsibility of the sponsor to ensure all investigators conduct the trial in strict compliance with the approved protocol. In addition, the sponsor should ensure that:

  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication between investigators at the various sites is facilitated
4.3
1.6, 3.0, 3.2, 4.8-4.9, and 4.25
8.0
3.6
Part II (4, 7, and 10) and Schedule 1 (Forms 30, 35, and 37)

Insurance & Compensation

Last content review/update: October 1, 2024

Insurance

The CanadaFDR does not require the sponsor to provide insurance coverage to investigators, institutions, or trial participants. However, the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, guides sponsors on providing insurance. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

Compensation

Injury or Death

The Canadian regulations do not require compensation for trial participants in the event of trial-related injuries or death. However, CAN-52 indicates that the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Trial Participation

The Canadian regulations do not require compensation for trial participation. However, as per the G-TCPS2 and CAN-52, the informed consent form (ICF) should contain a statement with a description of the anticipated prorated payment to the participant(s) that is reasonably expected for participation in the trial. Any compensation or incentive to participants must not be so excessive that it may unfairly influence participants or cause them to overlook important facts and risks. CAN-35 further states that the ICF should describe any compensation, incentives, or reimbursements to be paid or given to participants and how participant withdrawal will affect the offered compensation (e.g., prorated remuneration). If no compensation will be provided, this should be stated.

4.8 and 5.8
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Policies, Guidelines, and Resources, Consent Process (Consent Form Template)
Chapter 3 (Article 3.2)
Last content review/update: February 9, 2024

Insurance

As set forth in the NDPA-CTReg and the G-TrialsGCP, the sponsor is responsible for providing insurance coverage for any unforeseen injury to research participants. The sponsor should provide indemnity for the investigator(s) against claims arising from the clinical trial, except for claims that arise from malpractice or negligence.

According to the NDPA-CTReg, the G-CTConduct, and the G-InsuranceCover, an insurance certificate must be provided to the National Drug Authority (NDA) that is specific to the trial for which the clinical trial application is being submitted. The G-CTConduct also indicates that the clinical trial application must provide evidence that each member of the investigator team is covered by relevant malpractice insurance for the trial.

The G-InsuranceCover further states that the required insurance coverage for research participants in a specific trial at a given site must be obtained from a local insurance company that is registered and operating under law in Uganda. For additional details on the required elements of the insurance policy, see Section 7.0 of the G-InsuranceCover.

According to the G-TrialsGCP, the principal investigator (PI) is responsible for ensuring participants obtain their claim from the local insurance company in the event of any trial-related injury and/or resultant disability.

Compensation

Per the G-TrialsGCP, the sponsor must ensure that information on incentives offered to participants is included in the protocol and informed consent documents. If the study is multicenter, information on the incentives given at all the different trial sites must be provided. If the participating sites are multinational, then the differences in the incentives across the sites must also be explained.

According to the NGHRP, a care package for research participants should be prepared before initiation of a research project. Care and treatment for research participants should be provided with the ideal aim of providing the best proven intervention.

Injury or Death

In accordance with the NGHRP, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries, disability, or death. The sponsor must ensure that participants who suffer any trial-related injuries receive free medical treatment for such injuries, and financial or other assistance that would compensate them equitably for any resulting impairment, disability, or handicap. The sponsor should provide care until complete cure or stabilization of a trial-related injury. The investigator and/or study sponsor must pay the cost of referral and management of the condition when a referral has been made for a trial-related injury or a serious adverse event related to the study. Furthermore, the sponsor is required to ensure that research participants are not asked to waive their legal rights to seek compensation.

Per the NGHRP, a trial-related injury may be physical, social, economic, or psychological, and may be classified as follows:

  • Definitely: When injury is directly caused by participation in a research project
  • Probably: When injury is most likely explained by participation in a research project but when no definite proof of causality is evident
  • Possibly: When explanation for injury is equally due to participation in a research project or other cause
  • Unlikely: When injury is more likely explained by another cause other than participation in a research project

Subject to applicable laws in Uganda, research participants will be entitled to compensation when injury related to their participation in a research project is classified as “Probably” or “Definitely.”

According to the NGHRP, the sponsor and investigator must put in place a mechanism for compensating trial-related injury at the commencement of a study. The mechanism, which may include, inter alia, insurance, and medical care, should be acceptable to the institutional ethics committee (EC) (research ethics committee (REC) in Uganda). The EC, research participant, and/or investigator may initiate the compensation process. The EC, sponsor, and investigator must agree on an appropriate mechanism for arbitration.

Trial Participation

In the clinical trial application made to the NDA, the applicant must explain how the participant(s) will be compensated for their time and other inconveniences, in accordance with the G-CTConduct.

In addition, per the NGHRP, participants must be fairly compensated for inconveniences, time spent, and expenses incurred while taking part in a study such as travel costs, refreshments, meals, and any other compensation deemed appropriate by the EC. Research participants may also receive free medical services. The compensation or medical services must not be so out of proportion as to induce prospective research participants to consent to participate in the trial against their better judgment.

According to the G-TrialsGCP, the sponsor must ensure that participants are reimbursed for all reasonable costs incurred by their participation in the trial.

Post-Trial Access

In accordance with the NGHRP, the duration and sustainability of care and treatment for the participant after the study should be negotiated before initiation of the study. Sponsors are encouraged, but not obliged, to provide care for concurrent illnesses not associated with the research project. However, investigators and sponsors are obliged to manage serious adverse events related to the study (including paying for associated costs thereof) until they are fully resolved or stabilized. Investigators should provide relevant follow up procedures for participants for an appropriate period of time after the trial.

4.6 and Appendix I
3.0 and 7.0
3.12, 4.11, and 4.12
2.2, 6.1, 6.3-6.6, and 7.2
Part III (15) and Schedule 1 (Form 29)

Risk & Quality Management

Last content review/update: October 1, 2024

Quality Assurance/Quality Control

Per the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. Per CAN-50, Canada implements the ICH Guidance E8(R1): General Considerations for Clinical Studies (CAN-49), which provides guidance on conduct during the clinical trial. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

As indicated in CAN-52, the quality management system should use a risk-based approach that includes:

  • During protocol development, identifying processes and data that are critical to ensure participant protection and the reliability of trial results
  • Identifying risks to critical trial processes and data
  • Evaluating the identified risks against existing risk controls
  • Deciding which risks to reduce and/or which risks to accept
  • Documenting quality management activities and communicate to those involved in or affected by these activities
  • Periodically reviewing risk control measures to ascertain whether the implemented quality management activities are effective and relevant
  • In the clinical study report, describing the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken

As stated in the CanadaFDR and CAN-52, the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data generated, recorded, and reported in compliance with the protocol, CAN-52, and the applicable regulatory requirements. The sponsor is responsible for obtaining agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. A written agreement must be signed by both the sponsor and the investigator or any other parties involved with the clinical trial, verifying that both parties agree to the trial protocol, the monitoring and auditing practices, the SOPs, and their respective duties.

Per CAN-50, HC adopted and implements the ICH guidance on statistical principles for clinical trials (CAN-53), as well as the ICH addendum on estimands and sensitivity analysis (CAN-39), which presents a framework for defining an appropriate estimand for a clinical trial and conducting sensitivity analyses.

Monitoring Requirements

As part of its QA system, CAN-52 notes that the sponsor should ensure the trial is monitored and audited. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, CAN-52, and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial. The sponsor should ensure that the auditors are qualified by training and experience, and the auditors’ qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with their own SOPs and the auditor observations are documented. The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Per the HCNotice-ICH-E19, HC adopted and implements ICH guidance on selective safety data collection in specific late stage pre-approval or post-approval clinical trials (CAN-15). Selective safety data collection refers to the recording of certain data by investigators in case report forms. It does not affect the monitoring and clinical care of individual trial participants or documentation of their adverse events in medical records. See the HCNotice-ICH-E19 and the CAN-15 for more information.

Premature Study Termination/Suspension

The CanadaFDR and the G-CanadaCTApps state that if a trial is prematurely terminated or suspended, the sponsor should inform HC no later than 15 days after the termination or suspension. In addition, the sponsor should provide HC with the reason(s) for the termination or suspension and its impact on the proposed or ongoing clinical trials related to the drug in Canada by the sponsor. The sponsor should also promptly notify the qualified investigators of the termination or suspension and advise them in writing of any potential risks to the participants’ health. Further, the G-CanadaCTApps states that the sponsor’s notification to HC should include confirmation that the sale or importation of the drug to the discontinued sites has been stopped and that reasonable measures to ensure the return of all unused quantities of the drug will be taken. This notification must also be submitted for premature discontinuation of a clinical trial or clinical trial site outside Canada where there are ongoing trials with the drug in Canada.

According to CAN-52, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the ethics committee (EC) should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

Purpose and Scope, and Glossary
5.0-5.2, 5.18, 5.19, 5.21, and 6.10
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
2.8.1
Part C (Division 5 (C.05.007-008, C.05.010, and C.05.015))
Last content review/update: February 9, 2024

Quality Assurance/Quality Control

The NDPA-CTReg states that the sponsor should maintain quality assurance and quality control systems for the conduct of clinical trials and for the generation of documentation, recording, and reporting of data. The G-TrialsGCP indicates that the sponsor is also responsible for implementing the systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, good clinical practice (GCP), and the applicable regulatory requirement(s). Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.

According to the G-TrialsGCP, the sponsor should implement a quality management system throughout all stages of the trial process, and should focus on the trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach including: critical process and data identification, risk identification, risk evaluation, risk control, risk communication, risk review, and risk reporting. For additional details, see the G-TrialsGCP.

Monitoring Requirements

As per the G-TrialsGCP, the sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports. The observations and findings of the auditor(s) should be documented and accessible to the institutional ethics committee (EC) (research ethics committees (RECs) in Uganda) and the National Drug Authority (NDA). The audit report should be submitted to the NDA if evidence of GCP or protocol non-compliance is found.

The G-TrialsGCP further states that in accordance with the NDPA-CTReg, the sponsor should appoint a monitor tasked with trial oversight and reporting on the progress of a study. The monitor should ideally have adequate medical, pharmaceutical, and scientific qualifications. The investigator(s) should accept the possibility of an audit or monitoring visit by an independent auditor appointed by the sponsor, and/or an inspection by the NDA, EC, or relevant local and international regulatory authorities.

Premature Study Termination/Suspension

Per the NDPA-CTReg, in the case of a sponsor-initiated clinical trial termination, the sponsor must notify the NDA within 15 days using the format specified in Schedule 2 of the NDPA-CTReg or UGA-5. The notification must give reasons for the termination, indicate the disposal process for the unused investigational product, and give the effective date of the termination. The G-CTConduct further requires that evidence of the NDA notification be provided to the EC and the Uganda National Council for Science and Technology (UNCST).

In addition, the G-TrialsGCP requires that if a trial is prematurely terminated or suspended for any reason, the investigator should inform the participants, assure appropriate therapy and follow-up for the participants, and inform the NDA. Furthermore, if the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should inform the institution where applicable, and the investigator/institution should inform the sponsor and the EC. The investigator should provide the sponsor and the EC with a detailed written explanation of the termination or suspension.

5.6
1.7, 3.9, 4.3-4.4, 4.20, 4.21
Part II (12), Part III (15), and Schedule 2 (Format of Report for Terminated Clinical Trial)

Data & Records Management

Last content review/update: October 1, 2024

Electronic Data Processing System

Per the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, when using electronic trial data handling processing systems, the sponsor must ensure and document that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. To validate such systems, the sponsor should use a risk assessment approach that takes into consideration the system’s intended use and potential to affect human subject protection and reliability of trial results. In addition, the sponsor must maintain standard operation procedures (SOPs) that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. With respect to the use of these computerized systems, the responsibilities of the sponsor, investigator, and other parties should be clear, and the users should receive relevant training. Note per CAN-50, HC-implemented ICH guidelines take precedence over other HC guidance when they are not consistent. Refer to CAN-52 for additional information.

The G-FDR-0100 provides that if electronic records are generated during a clinical trial, then the electronic system must be validated to confirm that the system’s specifications meet the goals and requirements for the clinical trial. This evidence of validation should be kept for the required record retention period and available for inspection by Health Canada (HC) inspectors. See the G-FDR-0100 for additional details.

Records Management

As set forth in the CanadaFDR and the CanadaFDR1024, the sponsor must record, handle, and store all trial-related information to allow complete and accurate reporting, interpretation, and verification. The CanadaFDR requires the sponsor to maintain all trial-related records for a period of 15 years. Per the G-FDR-0100, sponsors may also be required to maintain records under provincial law, institutional policies, and contractual agreements with investigators, ethics committees (ECs), or others. Where it is not possible to comply with both sets of requirements, the CanadaFDR would govern and the records must be maintained for 15 years.

Pursuant to CanadaFDR1024, the sponsor must submit requested records to HC within 48 hours if safety concerns arise. Additionally, to facilitate inspection of a site, the sponsor must submit information to HC within seven (7) days of a request. Per CAN-8, an attestation must be completed by the EC that reviewed and approved the clinical trial. The completed attestation must be retained by the clinical trial sponsor for a period of 15 years. The attestation should not be submitted to HC unless requested.

In addition, CAN-52 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

1.65, 5.5, 6.10, and 8
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
5.12
Regulatory Impact Analysis Statement
Part C (Division 5 (C.05.012))
Last content review/update: February 9, 2024

Electronic Data Processing System

According to the G-TrialsGCP, the sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, handle the data, verify the data, conduct the statistical analyses, and prepare the trial reports. When using electronic trial data handling or remote electronic trial data systems, the sponsor should:

  • Ensure and document that the electronic data processing system(s) conform(s) to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance
  • Maintain standard operating procedures (SOPs) for using these systems
  • Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data
  • Maintain a security system that prevents unauthorized access to the data, and a list of the individuals who are authorized to make data changes
  • Maintain adequate backup of the data
  • Safeguard the blinding, if any
  • Ensure the integrity of the data, including any data that describes the context, content, and structure

For additional details, see Section 4.8 of the G-TrialsGCP.

The G-TrialsGCP states that quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. The sponsor should base their approach to validation of electronic data processing systems on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human participant protection and reliability of trial results. The sponsor should maintain a documented record of SOPs that guide step-by-step retrospective assessment of data quality and study performance. These SOPs should cover system setup, installation, and use. The SOPs should also describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. The responsibilities of the sponsor, investigator, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use.

According to the G-TrialsGCP, satisfactory maintenance and back-up procedures for computer databases must be provided. Case report forms (CRFs) should be designed to meet the specific data requirements set out in the study protocol. The effects of missing and inaccurate data should be minimized to maintain data quality. The system for routinely checking the data collection and entry throughout the course of the trial should be documented. Checks for validity and consistency of the database should be on separate items as well as on predetermined combinations of items in the CRFs. The SOP for data editing should ensure that any queries about data validation are brought to the attention of the investigators. Database lock should be done after completion of the validation and editing processes are documented.

Records Management

The G-TrialsGCP and the G-CTConduct state that the sponsor and the PI are responsible for archiving and ensuring the safety of all trial-related documentation. Per the NDPA-CTReg, documents and information provided to the National Drug Authority (NDA) along with a clinical trial application for unregistered investigational products (IPs) should be kept for 20 years following the trial's completion. Documentation for trials involving IPs to be registered should be kept for two (2) years after the registration of the IP. The NDPA-CTReg and the G-CTConduct further state that the holder of the clinical trial certificate should inform the NDA in writing prior to destroying the documents. Per the G-CTConduct, documents may be stored in electronic (soft and scanned) or hard copies.

In addition, the G-TrialsGCP requires that if the sponsor discontinues the clinical development of an IP, the sponsor should maintain all sponsor-specific essential documents for at least two (2) years after formal discontinuation. The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention and should notify the investigator(s)/institution(s) in writing when the trial-related records are no longer needed.

According to the NGHRP, collaborating research partners must agree on appropriate data access and use rights before commencement of the study. Investigators must have in place mechanisms for maintaining the confidentiality of research participants and their communities. Furthermore, a collaborating research partner must not transfer data to a third party without the written consent of the other partner. Local investigators must have unrestricted access rights to data sets collected through a collaborative research project. Lastly, investigators must ensure that research records from which the data has been obtained are available at the research site for at least five (5) years after completion of the research project. Electronic records are acceptable.

9.5
4.8, 5.1, and 5.3-5.5
11.2
Part II (4) and Part III (18)

Personal Data Protection

Last content review/update: July 26, 2024

Responsible Parties

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ethics committees (ECs), states that where researchers seek to collect, use, share, and access different types of information or data about participants, they should determine whether the information or data proposed in research may reasonably be expected to identify an individual. Researchers and ECs must consider whether information is identifiable or non-identifiable.

Data Protection

Per CAN-42, the Office of the Privacy Commissioner of Canada provides advice and information for individuals about protecting personal information, and enforces the two (2) federal privacy laws that set out the rules for how federal government institutions and certain businesses must handle personal information, including health data. The PrivAct covers the personal information-handling practices of federal government departments and agencies in Canada, and the PIPEDA regulates private businesses’ data protection practices. In addition, some provinces and territories have laws that deal specifically with protection of personal health information. See CAN-43 for a list of provincial and territorial privacy laws and webpages.

Per the G-TCPS2, in the research context, the most simplified method to protect participants is through the collection and use of anonymous or anonymized data. When anonymized data is not possible or desirable, a next best alternative is to use de-identified data, which is provided to the researcher in de-identified form and the existing key code is accessible only to a custodian or trusted third party who is independent of the researcher. Where it is not feasible to use anonymous or anonymized data for research, the ethical duty of confidentiality and the use of appropriate measures to safeguard information become paramount. Researchers should consult their ECs if they are uncertain about whether information proposed for use in research is identifiable (e.g., when proposing to link anonymized or coded data sets).

Consent for Processing Personal Data

Both PIPEDA and the PrivAct require consent for the use of personal data, including health data, except under prescribed conditions, such as for research or during emergencies. Also see CAN-43 for provincial and territorial privacy laws.

Chapter 2 (Article 2.1) and Chapter 5 (A. Key Concepts)
Part I (2, 6.1, and 7)
3, 7, and 8
Last content review/update: February 9, 2024

Responsible Parties

For the purposes of data protection requirements, the sponsor may act as a “data controller” in relation to research data. As per the NITA-U-PrivAct, the data controller determines the purposes for and the manner in which personal data is processed or is to be processed. The “data processor” processes personal data on behalf of the data controller. Data controllers and processors must be registered with the National Information Technology Authority - Uganda (NITA-U). See the NITA-U-PrivAct, the NITA-U-PrivReg, and the PDPO-Note for detailed registration requirements.

Data Protection

As per the NITA-U-PrivAct, a data controller or processor must:

  • Be accountable to the data subject for data collected, processed, held, or used
  • Collect and process data fairly and lawfully
  • Collect, process, use, or hold adequate, relevant, and not excessive or unnecessary personal data
  • Retain personal data for the period authorized by law or for which the data is required
  • Ensure quality of information collected, processed, used, or held
  • Ensure transparency and participation of the data subject in the collection, processing, use, and holding of the personal data
  • Observe security safeguards in respect of the data

See Part III of the NITA-U-PrivAct and NITA-U-PrivReg for detailed requirements on data processing, record retention, and processing of personal data outside Uganda.

Consent for Processing Personal Data

As delineated in the NITA-U-PrivAct, for the purposes of processing personal data, consent means any freely given, specific, informed, and unambiguous indication of the data subject’s wish which, by a statement or by a clear affirmative action, signifies agreement to the collection or processing of the data subject’s personal data.

According to the NITA-U-PrivAct, a data controller or data processor must obtain the consent of the data subject before collecting or processing personal data, and the data must be collected for a lawful, specific purpose. Unless otherwise provided under the NITA-U-PrivAct, a data subject has the right to object to the collection or processing of personal data at any time. See the NITA-U-PrivAct and NITA-U-PrivReg for detailed requirements on consent to data collection or processing, record retention, and processing of personal data outside Uganda.

The NITA-U-PrivAct and NITA-U-PrivReg further state that data subjects have a right to (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

  • Request a data controller to give a description of the personal data held by the controller
  • Prevent processing of personal data
  • Appeal a decision to continue processing personal data
  • Request a data controller to correct or delete personal data about the data subject that is inaccurate, irrelevant, excessive, out of date, incomplete, misleading, or obtained unlawfully

See the NITA-U-PrivAct and NITA-U-PrivReg for more information on data subject rights.

Children

According to the NITA-U-PrivAct, personal data relating to children must not be collected or processed unless it is carried out with the prior consent of the legal representative/guardian; is necessary to comply with the law; or is for research or statistical purposes. The NITA-U-PrivReg further requires that every data collector, data processor, and data controller establish a system to determine the age of participants whose personal data is to be collected, processed, or stored, and where the data relates to a child, describe the manner of obtaining consent of a legal representative/guardian, where necessary.

Part I (2), Part II (3), Part III, Part VI, and Part V
Parts III, VI, and VIII

Documentation Requirements

Last content review/update: October 1, 2024

Obtaining Consent

In all Canadian clinical trials, a freely given informed consent is required from each participant in accordance with the requirements set forth in the CanadaFDR, the G-TCPS2, CAN-35, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

As per the CanadaFDR, the G-TCPS2, and CAN-52, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (known as a Research Ethics Board (REB) in Canada) and provided to HC with the clinical trial application (CTA). (See the Required Elements section for details on what should be included in the form.)

The G-TCPS2 and CAN-52 state that the qualified investigator (QI) must provide detailed research study information to the participant or legal representative/guardian. As delineated in the G-TCPS2, CAN-35, and CAN-52, the ICF content should be in plain language (i.e., non-technical and easy to understand) and provided in a format that facilitates understanding. For example, written documentation may be supplemented with audio and/or visual aids. The participant and legal representative/guardian should also be given adequate time to consider whether to participate. CAN-35 notes that the person obtaining consent may also need to explain the consent form verbally to ensure that the participant fully understands the information. See CAN-35 for informed consent and assent templates and sample forms.

Re-Consent

According to CAN-52, any change in the ICF that is relevant to the participant’s consent should be approved by the institutional EC prior to implementing any changes. The participant or legal representative/guardian should also be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented.

Per the G-TCPS2, consent must be maintained throughout the research project. Researchers have a continuous duty to provide participants with all information relevant to their ongoing consent to participate in the research. Consent begins with the initial contact (e.g., recruitment) and carries through to the end of participation in the study. Throughout the clinical trial, researchers have a continuous responsibility to provide participants and ECs with all information relevant to participants’ ongoing consent to participate in the research. The researcher also must notify participants of any changes to the research project that may affect them. These changes may have ethical implications, may be relevant to their decision to continue in the study, or may be unique to the particular circumstances of individual participants. Specifically, researchers must disclose changes to the risks or potential benefits of the research. Change in participant capacity is an important element of ongoing consent. Rather than an age-based approach to consent, researchers should use an approach based on decision-making capacity in compliance with any laws governing research participation. This includes those whose decision-making capacity is in the process of development, those whose decision-making capacity is diminishing or fluctuating, and those whose decision-making capacity remains only partially developed. Mechanisms should be in place from the outset to identify and address any changes that could affect consent. Further, within the limits of consent provided by the participant, researchers should disclose to the participant any material incidental findings discovered in the course of research. Incidental findings are considered to be material incidental findings if they are reasonably determined to have significant welfare implications for the participant or prospective participant. Where material incidental findings are foreseeable, researchers should inform participants during the initial consent process. In addition, researchers should develop a management plan for review by the EC. For more information on how to address material incidental findings, see G-ConsentMatIncFindings.

Language Requirements

CAN-35 further specifies that consent forms should be provided in the language that participants are most comfortable with. The G-TCPS2 and CAN-52 require the ICF to be presented in plain language that the participant is able to understand. Per CAN-35, ICFs should be translated where it is relevant to particular communities. If there is a language barrier, the G-TCPS2 indicates that the qualified investigator should select an intermediary who has the necessary language skills to ensure effective communication. Further, per CAN-35, the level of language used should be appropriate to the age and comprehension/reading level of the participant population, generally at approximately a grade 6-8 reading level.

Documenting Consent

As per the G-TCPS2, CAN-52, and CAN-35, the participant or legal representative/guardian, as well as the qualified investigator, must sign and date the ICF. CAN-52 and the G-FDR-0100 state that the QI should retain the signed ICF. CAN-35 indicates that information letters and ICFs must be presented on institutional/department letterhead.

According to CAN-52, where the participant is illiterate and/or the legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

  • The written ICF and any other written information to be provided to the participant is read and explained to the participant and legal representative/guardian
  • The participant and legal representative/guardian have orally consented to the participant’s involvement in the trial, and have signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or legal representative/guardian should receive a copy of the signed and dated ICF.

As per the G-TCPS2 and CAN-52, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or appear to waive the participant’s legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representative(s) from their liabilities for any negligence.

Per CAN-35, in some situations, written consent is not be feasible or desirable, for example due to logistical issues or because of the preferences of the participants. In addition, some individuals may perceive written consent as an attempt to legalize the consent process, thereby creating mistrust. It is also important to recognize that in some cultures written consent is not consistent with community traditions. In these cases, it may be more appropriate to use a handshake, a verbal agreement, or oral consent. Article 10.2 of the G-TCPS2 further indicates that researchers can use a range of procedures to seek and document consent, including oral consent documented in field notes, and other forms of recording (e.g., a consent log, audio or video recordings, or other electronic means). Evidence of consent may also be documented via completed questionnaires (in person, by mail, or by email or other electronic means). ECs should consider the power relationship that might exist between researchers and participants, and whether a waiver of the requirement for signed written consent may affect the welfare of the participants. If researchers plan to obtain non-written consent, they must explain their strategy to the EC.

Waiver of Consent

As explained in the G-TCPS2, there are research situations that call for alterations of consent. The EC may approve research that involves an alteration to the consent requirements if the EC is satisfied, and documents, that all of the following apply:

  • The research involves no more than minimal risk to the participants
  • The change to consent requirements is unlikely to adversely affect the welfare of participants
  • It is impossible or impracticable to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required
  • In the case of a proposed alteration, the exact nature and extent of any proposed alteration is defined
  • There is a plan to brief participants and offer the option of refusing consent and/or withdrawing data and/or human biological materials
4.8, 8.2, and 8.3
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Policies, Guidelines, and Resources; Consent Process (Key Considerations)
5.5, 5.6, 5.8, and 5.10
Chapters 3 and 10
Part C (Division 5 (C.05.005, C.05.006, C.05.008, and C.05.010))
Last content review/update: February 9, 2024

Obtaining Consent

In all Ugandan clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the NGHRP and the G-TrialsGCP.

As per the NGHRP, the NDPA-CTReg, the G-CTConduct, and the G-TrialsGCP, the informed consent form (ICF) and the participant information leaflet are viewed as essential documents that must be reviewed and approved by an accredited institutional ethics committee (EC) (research ethics committee (REC) in Uganda) and provided to the National Drug Authority (NDA) with the clinical trial application. (See the Required Elements section for details on what should be included in the ICF.)

The G-TrialsGCP states that before informed consent may be obtained, the principal investigator (PI), or a person designated by the PI, should provide the participant or legal representative/guardian ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the participant or legal representative/guardian.

As stated in the NGHRP, an investigator must seek informed consent only after ascertaining that the prospective research participant has adequate understanding of the relevant facts and of the consequences of participation. For certain types of research, the EC may require the investigator to administer a comprehension test (or test of understanding) to ensure that prospective research participants have acquired adequate understanding of the relevant facts and of the consequences of participation.

Per the G-TrialsGCP, if a participant is unable to read or if the legal representative/guardian is unable to read, an impartial witness should be present during the entire informed consent discussion. The written ICF and any other written information to be provided to participants should be read and explained to the participant or legal representative/guardian. According to the NGHRP, verbal consent may be obtained in studies that present no more than minimal risk or in studies where for justifiable reasons written consent may not be feasible. ECs reserve the right to determine when verbal informed consent may be appropriate and acceptable.

Additionally, as stated in the G-TrialsGCP, the language used in the oral and written information about the trial, including the written ICF, should be as non-technical as practical and should be understandable to the participant or legal representative/guardian and the impartial witness, where applicable. Neither the PI, nor the trial staff, should coerce or unduly influence a participant to participate or to continue to participate in a trial. None of the oral and written information concerning the trial, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence and/or malpractice.

See the NGHRP and the G-TrialsGCP for detailed requirements for obtaining consent.

Re-Consent

According to the G-TrialsGCP, the written ICF and any other written information to be provided to participants should be revised whenever important new information becomes available that may be relevant to the participant’s consent. Any revised written ICF and written information should receive the EC's approval/favorable opinion in advance of use. The participant or legal representative/guardian should be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented.

The NGHRP specifies that re-consent from participants must be obtained if there are changes in the conditions or procedures of the research or if new information becomes available that could affect the participant’s willingness to continue in the research.

Language Requirements

As per the NGHRP and the G-CTConduct, the ICF should be written in English and in a vernacular language that the participant is able to understand. The G-TrialsGCP further indicates that for multicenter trials, the informed consent procedure must be tailored to local conditions, and ICFs must be translated into the local language and submitted to the EC for approval.

Documenting Consent

The G-TrialsGCP and the NGHRP state that prior to participation in the trial, the written ICF should be signed and personally dated by the participant or legal representative/guardian, and by the person who conducted the informed consent discussion.

The G-TrialsGCP delineates that the impartial witness for participants unable to read should sign and personally date the ICF, after the participant or legal representative/guardian has orally consented to the participation in the trial. If capable of doing so, the participant or legal representative/guardian should sign and personally date the ICF. By signing the ICF, the impartial witness attests that the information in the ICF and any other written information was accurately explained to, and apparently understood by, the participant or legal representative/guardian, and that informed consent was freely given.

According to the NGHRP, a thumbprint on the ICF is also acceptable in lieu of a signature. Where the use of signed consent forms is not feasible, alternative viable methods should be employed.

The G-TrialsGCP and the NGHRP indicate that a copy of the signed ICF must be offered to the participant or legal representative/guardian prior to participation in the trial. The G-TrialsGCP further specifies that during the course of the trial, the participant or legal representative/guardian should receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to the participant.

Waiver of Consent

According to the NGHRP, an EC may waive some or all of the requirements for the investigator to obtain informed consent and/or a signed/thumb-printed consent form for some or all of the research participants of a particular study if the EC determines that:

  • The research project carries no more than minimal risk (risk that is no more than the risks encountered in normal daily life in a stable society)
  • The research project could not practicably be carried out without the waiver or alteration (whenever appropriate the research participants will be provided with additional pertinent information after participation)
  • Deception needs to be applied to achieve the objectives of the study
  • The only record linking the research participant and the research project would be the ICF and the risk to the research participant would be potential harm resulting from a breach of confidentiality
  • The research participant is involved in an emergency situation and informed consent cannot be reasonably obtained from the individual or the representative
4.6 and 4.7
3.7 and 4.25
4.5, 4.7-4.8, 5.1-5.2, and 5.4-5.5
Part II (4) and Part III (14)

Required Elements

Last content review/update: October 1, 2024

Based on the G-TCPS2, the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), and CAN-35, the informed consent form (ICF) should include the following statements or descriptions in plain language, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

  • The study involves research and an explanation of its purpose and duration
  • The trial treatment(s) and the probability for random assignment to each treatment
  • The procedures to be followed, including all invasive procedures
  • The participant’s responsibilities
  • Those aspects of the trial that are experimental
  • Any reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
  • Any reasonably expected benefits; if no benefit is expected, the participant should be made aware of this
  • The disclosure of specific alternative procedure(s) or therapies available to the participant, and their important potential benefits and risks
  • Compensation and/or treatment available to the participant in the event of a trial-related injury
  • The anticipated prorated payment, if any, to the participant for participating in the trial
  • Any expenses the participant needs to pay to participate in the trial
  • That participation is voluntary, and that the participant can refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled
  • Information concerning the possibility of commercialization of research findings, and the presence of any real, potential, or perceived conflicts of interest on the part of the researchers, their institutions, or the research sponsors
  • Confidentiality of records identifying the participant will be maintained, and permission given to monitors, the auditors, the ethics committee (EC), and Health Canada (HC) to access the participant’s medical records to verify the procedures and/or data, without violating the confidentiality of the participant, insofar as the applicable laws and regulations permit, and that, by signing a written ICF, the participant or legal representative/guardian is authorizing such access
  • That records identifying the participant will not be made publicly available, insofar as the applicable laws and/or regulations permit; if the results of the trial are published, the participant’s identity will remain confidential
  • The participant or legal representative/guardian will be notified in a timely manner if information becomes available that may affect the participant’s willingness to continue
  • The qualified investigator’s contact information for further information regarding the trial and the rights of participants, and whom to contact in the event of a trial-related injury
  • The identity and contact information of a qualified designated representative who can explain scientific or scholarly aspects of the research to participants
  • Information on stopping rules, foreseeable circumstances, and/or reasons under which the participant’s involvement in the trial may be terminated
  • The approximate number of participants in the trial

Per CAN-50, Canada has implemented CAN-52.

Per CAN-35, if blood is taken, indicate total volume (e.g., teaspoons and milliliter equivalent) and note the possibility of bruising or swelling while giving blood, or other possible discomforts at the site where blood is drawn. Further, state that there may be minimal chance of infection and that discomforts experienced will be brief and transient.

CAN-35 also indicates that participants should not be told if an EC has approved the study, since this may appear to offer a guarantee of safety. Further, no clause or language should be used to excuse or appear to excuse investigators or other persons or institutions involved from liability for their negligence or other faults. Sample consent forms can be found in CAN-35.

See the Vulnerable Populations and Consent for Specimen sections for further information.

4.8
Efficacy guidelines
Policies, Guidelines, and Resources, and Consent Process (Sample consent forms)
Chapter 3
Last content review/update: February 9, 2024

Based on the NGHRP, the NDPA-CTReg, and the G-TrialsGCP, the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

  • The study involves research and an explanation of its nature and purpose
  • The procedures to be followed
  • The expected duration of the trial
  • The trial treatment(s) and the probability for random assignment to each treatment (where appropriate)
  • The participant's responsibilities
  • Those aspects of the trial that are experimental
  • Any reasonably foreseeable risks or discomforts to the participant, and whether the project involves more than minimal risk
  • Any benefits to the participant or to others that may be reasonably expected from the research; if no benefit is expected, the participant should also be made aware of this
  • The disclosure of specific appropriate alternative procedures or therapies available to the participant
  • The extent to which confidentiality of records identifying the participant will be maintained and who will have access to the participant’s medical records
  • For research involving more than minimal risk, the policy on compensation and/or medical treatment(s) available to the participant in the event of a trial-related injury
  • The extent of the investigator’s responsibility, where applicable, to provide medical services to the participant
  • The nature, form, and extent of compensation for participation
  • The identity of a sponsor and any potential conflict of interests
  • The sponsors’ and the investigators’ institutional affiliation(s)
  • A contact name and number of the principal investigator and/or site investigator
  • Participation is voluntary, the participant can withdraw from the study at any time, and refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled
  • The participant or legal representative/guardian will be notified in a timely manner if significant new findings develop during the study which may affect the participant's willingness to continue
  • A witness may represent vulnerable populations during the informed consent process, if applicable
  • The study has been approved by an accredited Ugandan-based institutional ethics committee (EC) (research ethics committee (REC) in Uganda)
  • The particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable
  • Foreseeable circumstances under which the investigator(s) may remove the participant without consent
  • Additional costs to the participant that may result from participation in the study
  • The consequences of a participant’s decision to withdraw from the research and procedures for orderly withdrawal by the participant
  • The approximate number of participants in the research study
  • If the research involves collecting biological or genetic materials, participants must be provided with an explanation on how specimens will be managed at the end of the study. If samples will be stored for future use, separate consent should be obtained
  • Whether, when, and how any of the products or interventions proven by the study to be safe and effective will be made available to participants at the end of the study, and if the participants will be expected to pay for them

Compensation Disclosure

According to the G-TrialsGCP, the sponsor must ensure that information on incentives offered to participants is included in the informed consent documents. If the study is multicenter, information on the incentives given at all the different trial sites must be provided. If the participating sites are multinational, then the differences in the incentives across the sites must also be explained.

3.7 and 4.12
5.1-5.4
Part III (14)

Participant Rights

Last content review/update: October 1, 2024

Overview

In accordance with the CanadaFDR, the G-TCPS2, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), Canada’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-TCPS2 and CAN-52, which Canada has implemented per CAN-50, state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

The informed consent template in CAN-35 provides that if a participant has any questions about their rights, they should contact:

Health Canada-PHAC Research Ethics Board Secretariat
70 Colombine Driveway, Room 941C, PL: 0909C
Brooke Claxton Building, Tunney's Pasture
Ottawa, ON K1A 0K9
Telephone: 613-941-5199
Fax: 613-941-9093
reb-cer@hc-sc.gc.ca

The Right to Participate, Abstain, or Withdraw

As stated in the G-TCPS2 and CAN-52, the participant or legal representative/guardian should be informed that participation is voluntary, that they may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

Per CAN-35, participants should be assured that their participation is completely voluntary, they are under no obligation to participate, and they are free to withdraw at any time without consequence. It should be made clear that their decision to withdraw will not influence their relationship with the researcher in any way. The researcher should explain what will happen to participant samples or data if they choose to withdraw. If applicable, clearly state the point in the study at which removal of samples or data becomes difficult or impossible.

The Right to Information

As per the G-TCPS2 and CAN-52, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation or treatment in the case of injury, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

According to the G-TCPS2 and CAN-52, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

Per CAN-35, the ICF should explain what information will be collected about participants and for what purpose, including the type of information that will be collected (e.g., will it be coded or de-identified?) and how it will be stored. Further, the ICF should state who will have access to the collected information and describe the efforts that will be made to prevent the risk of participant re-identification. Limits to confidentiality and additional requirements for projects led by HC or the Public Health Agency of Canada (PHAC) are provided in CAN-35.

The Right of Inquiry/Appeal

The G-TCPS2 and CAN-52 state that the research participant or legal representative/guardian should be provided with contact information for the individual responsible for addressing trial-related inquiries and/or the participant’s rights.

The Right to Safety and Welfare

CAN-52, which upholds the Declaration of Helsinki, clearly state that a research participant’s right to safety and the protection of their health and welfare must take precedence over the interests of science and society.

See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.

1.27, 3.1, and 4.8
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Consent Process (Consent Form Template)
5.1 and 5.5
Chapter 1 (Article 1.1), Chapter 2, and Chapter 3 (Articles 3.1 and 3.2)
Part C (Division 5 (C.05.001 and C.05.005))
Last content review/update: February 9, 2024

Overview

The G-TrialsGCP states that in obtaining and documenting informed consent, the principal investigator (PI) or delegate should comply with the ethical principles that have their origin in the Declaration of Helsinki (UGA-27), the NGHRP, and the G-TrialsGCP. Additionally, in accordance with the NGHRP, the NDPA-CTReg, and the G-TrialsGCP, a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process.

See the Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information regarding requirements for participant rights.

The Right to Participate, Abstain, or Withdraw

As set forth in the NGHRP and the G-TrialsGCP, the participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

According to the NGHRP and the G-TrialsGCP, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

The NGHRP and the G-TrialsGCP indicate that all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. It is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

The Right of Inquiry/Appeal

As per the NGHRP and the G-TrialsGCP, the research participant or legal representative/guardian should be provided with contact information for the investigator(s) and the institutional ethics committee (EC) (research ethics committee (REC) in Uganda) to address trial-related inquiries in the event of any injury and/or to appeal against a violation of the participants’ rights.

The Right to Safety and Welfare

The NGHRP and the NDPA-CTReg state that a research participant’s right to safety and the protection of the participant’s health and welfare must take precedence over the objectives of biomedical research.

3.7
1.1, 1.3-1.4, 2.2-2.3, and 5.1-5.4
Part II (4) and Part III (14)
Last content review/update: October 1, 2024

The G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. As per CAN-52, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or legal representative/guardian, or, if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee (EC) (known as Research Ethics Board (REB) in Canada) must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

Per G-TCPS2, research involving medical emergencies must be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance with criteria established in advance of such research by the EC. The EC may allow research that involves medical emergencies to be carried out without the consent of participants, or legal representatives/guardians, if all of the following apply:

  • A serious threat to the prospective participant requires immediate intervention
  • Either no standard efficacious care exists, or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care
  • Either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant
  • The prospective participant is unconscious or lacks capacity to understand the risks, methods, and purposes of the research project
  • Authorization from the legal representative/guardian cannot be secured in sufficient time, despite diligent and documented efforts to do so
  • No relevant prior directive by the participant is known to exist
4.8
Information on ICH guidelines implemented by Health Canada and Efficacy Guidelines
Chapter 3 (Articles 3.7-3.9)
Last content review/update: February 9, 2024

The NGHRP allows the institutional ethics committee (EC) (research ethics committee (REC) in Uganda) to waive some or all of the informed consent requirements in instances of emergency situations where consent cannot be reasonably obtained from the participant or legal representative/guardian.

The G-TrialsGCP further states that in emergency situations, when prior consent of the participant is not possible, the consent of the legal representative/guardian, if present, should be requested. When prior consent of the participant is not possible and the legal representative/guardian is not available, enrollment of the participant should require measures that are described in the protocol and/or elsewhere, with documented approval by the EC, to protect the rights, safety, and well-being of the participant and to ensure compliance with applicable regulatory requirements. The participant or legal representative/guardian should be informed about the trial as soon as possible and provide consent to continue or other consent as appropriate, should this be requested.

3.7
5.5 and 8.1

Vulnerable Populations

Last content review/update: October 1, 2024

Overview

As per the G-TCPS2, in all Canadian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52) characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from not participating. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students; subordinate hospital and laboratory personnel; employees of the pharmaceutical industry; members of the armed forces; and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

CAN-52, which Canada has implemented per CAN-50, specifies that ethics committees (ECs) (known as Research Ethics Boards in Canada) must pay special attention to protecting participants who are from vulnerable populations. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

See the Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired sections for additional information about these vulnerable populations.

1.61, 3.1, and 4.8
Information on ICH guidelines implemented by Health Canada and Efficacy Guidelines
Chapter 3 (Article 3.9) and Chapter 4 (Article 4.7)
Last content review/update: February 9, 2024

Overview

According to the NGHRP, additional safeguards must be included in a study to protect vulnerable populations. Vulnerable populations are characterized as research participants who are incapable of protecting their own interests due to insufficient power, intelligence, education, resources, strength, or other requisite attributes. These participants are also considered to be vulnerable due to their limited capacity or freedom to provide or decline consent. Vulnerable populations include children/minors, prisoners, the homeless, substance abusers, mentally and physically handicapped, armed forces, terminally ill, and pregnant women. Characteristics that constitute vulnerability in such populations include one (1) or more of the following:

  • Limited economic empowerment
  • Conflict and post-conflict situations
  • Inadequate protection of human rights
  • Discrimination on the basis of health status
  • Limited availability of health care and treatment options
  • Communities in acute disaster and disease epidemics

As per the G-TrialsGCP, vulnerable participants also include individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention.

The NGHRP states that where appropriate, there should be a provision for involvement of a community in the research process right from inception to post research period. Additionally, the institutional ethics committee (EC) (research ethics committee (REC) in Uganda) must carefully consider and approve the mode of consent for participants from vulnerable populations. In order to protect vulnerable communities, ECs must ensure that selection of the particular community is justified by the research goals, and the research is relevant to the needs and priorities of the community in which it is to be conducted.

Per the NGHRP, for all vulnerable populations and individuals:

  • Research can only be conducted in the population and with individuals if the objectives of the research cannot be addressed using non-vulnerable populations and individuals
  • Risk of participating in research is justified by anticipated benefits
  • The intervention or procedure presents experiences that are commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations
  • The intervention or procedure is likely to yield generalizable knowledge about the population or individual’s disorder or condition that is of vital importance for the understanding or amelioration of that disorder or condition
  • ECs may co-opt a person knowledgeable about and has experience working with the vulnerable group and individuals

The G-TrialsGCP further indicates that special protections for vulnerable populations can include:

  • Allowing no more than minimal risks for procedures that offer no potential individual/direct benefits for participants
  • Supplementing the participant’s agreement by the permission of family members, legal guardians, or other appropriate representatives
  • Requiring that the research be carried out only when it is targeting conditions that affect these populations
  • Safeguards can be designed to promote voluntary decision-making, limit the potential for confidentiality breaches, and otherwise work to protect the interests of those at increased risk of harm
  • Appointment of advocates to the EC when such proposals for clinical trials on institutionalized individuals are under review

See the Children/Minors and Pregnant Women, Fetuses & Neonates sections for additional information about these vulnerable populations. See the NGHRP and the G-TrialsGCP for more examples of and details on vulnerable populations.

Persons in Hierarchical Relationships

As per the G-TrialsGCP, there is a possibility of diminished voluntariness of consent from potential participants who are in a subordinate relationship. Their agreement to volunteer may be unduly influenced, whether justified or not, by the expectation of preferential treatment if they agree to participate in the study or by fear of disapproval or retaliation if they refuse. Examples include medical and nursing students; subordinate hospital and laboratory personnel; workers in settings where research studies are conducted; and members of the armed forces or police.

1.1 and 2.3
4.7 and 8.0

Children/Minors

Last content review/update: October 1, 2024

Per CAN-35, because the G-TCPS2 does not specify an age of consent for children, the decision on whether to seek consent from children is based on whether they have the capacity to understand the research and the risks and benefits of their participation. Youth who have not reached the age of majority (either 18 or 19 depending on the province or territory) may still be old enough to provide their own consent. For children who are not sufficiently mature to provide consent but are able to understand the nature of study participation, researchers must obtain the child’s assent in addition to the consent of an authorized third party. The decision of a child not to assent must be respected regardless of whether third-party consent was obtained.

CAN-35 provides the following criteria for determining whether participants can provide their own consent, or whether an authorized third party should be involved:

  • The risk level associated with the research project
  • The legal requirements for age of consent in that jurisdiction
  • The characteristics of the research participant (e.g., maturity level)
  • In certain cases, the topic of the research itself

CAN-35 states that it is generally accepted that youth can consent to minimal risk studies at 16 years of age, and that assent should be sought from children beginning at approximately seven (7) years of age. However, it is ultimately up to the researcher to determine whether to obtain assent or consent from children, and to provide the rationale for this decision to the ethics committee (EC) (known as a Research Ethics Board in Canada). Researchers should also consider that within a single research project, some minors may be capable of consenting while others may not. See CAN-35 for additional details regarding obtaining consent from minors.

As per the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. All pediatric participants, however, should be informed to the extent compatible with the child’s understanding, and if capable, the pediatric participant should sign and personally date the ICF. Per CAN-50, Canada has implemented CAN-52. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

As stated in G-TCPS2, children should only participate in clinical studies when the research objective cannot be achieved with adult participants only. When considering the inclusion of children in research, the investigators and ECs must consider a child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the child’s welfare.

Assent Requirements

Per G-TCPS2 and TCPS2-InterpCnsnt, where a child has some ability to understand the significance of the research, the researcher must ascertain the wishes of that individual with respect to participation. Children—whose decision-making capacity is in the process of development—may be capable of verbally or physically assenting to, or dissenting from, participation in research. While their assent would not be sufficient to permit them to participate in the absence of consent by the child’s parent/legal guardian, their expression of dissent must be respected.

Further, according to CAN-12, which offers best practices and guidance to researchers and ECs in pediatric research and complements the G-TCPS2, provincial laws in Canada vary as to when a child is presumed to be legally competent to provide informed consent. Some provinces use age while others use a competence-based evaluation.

As per CAN-12, if the pediatric participant has the capacity for assent, then affirmative assent is required to participate in a study according to the participant’s level of development and capacities. When the child develops the legal capacity to provide informed consent or attains the legal age of majority (which depends on the province), researchers should obtain an informed consent. Regarding dissent, CAN-12 states that the researchers must respect the dissent of a child who is capable of understanding.

CAN-35 provides sample assent forms and templates. For more detail and guidance about best practices for research involving pediatric participants, see CAN-12.

Guidelines III and IV
4.8
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Consent Process (Key Considerations)
Chapter 3 (Article 3.10) and Chapter 4 (Article 4.4)
1
Last content review/update: February 9, 2024

The NGHRP and the G-CTChldrnWmn define a child as a person below the age of 18.

According to the G-CTChldrnWmn, data supporting the conduct of a clinical trial involving children should demonstrate that the benefit to the population outweighs the risk. For interventions or procedures that have no potential individual benefits for children:

  • The risks must be minimized and no more than minimal;
  • The purpose of the research must be to obtain knowledge relevant to the particular health needs of the population;
  • The social value of the research for the children is compelling, and the research cannot be conducted in any other population; and
  • Any research-related risk is the least possible for achieving the objectives of the research

While consent from the child’s parent or guardian is required in most cases, the NGHRP does allow for mature and emancipated minors, as described below, to provide consent. As per the NGHRP, mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient. Mature and emancipated minors are permitted to independently provide informed consent to participate in research if the following conditions exist:

  • The institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approves the research study as acceptable to the parents/legal guardians based on evidence from the community
  • The protocol provides clear justification for targeting mature and emancipated minors as participants, and for not involving parents/legal guardians in the consent process

Assent Requirements

The NGHRP requires a child’s affirmative agreement to participate in research when the child is eight (8) years of age and older. A child's assent is obtained after the parent’s/legal guardian’s consent is obtained. The child’s assent or dissent takes precedence over the parent’s/legal guardian’s consent.

The G-CTChldrnWmn further indicates that for pediatric studies, adequate provisions should be made for soliciting the assent of the children and permission of their parents/legal guardians. Investigators should provide an understandable age-specific informed assent and information sheet for children.

3 and 4.1
5.6, 5.8, and Glossary

Pregnant Women, Fetuses & Neonates

Last content review/update: October 1, 2024

As per the G-TCPS2, studies involving women of childbearing age, or who are pregnant, require additional safeguards to ensure that the research assesses the risks to the women and the fetuses. The following guidance applies to research involving materials related to human reproduction:

  • Research using materials related to human reproduction in the context of an anticipated or ongoing pregnancy must not be undertaken if the information can reasonably be obtained by alternative methods
  • Materials related to human reproduction for research use must not be obtained through commercial transaction, including exchange for services

Per the G-TCPS2, research on in vitro embryos already created and intended for implantation to achieve pregnancy is acceptable if:

  • The research is intended to benefit the embryo
  • Research interventions will not compromise the care of the woman, or the subsequent fetus
  • Researchers closely monitor the safety and comfort of the woman and the safety of the embryo
  • Consent was provided by the gamete donors

According to the G-TCPS2, research involving embryos that have been created for reproductive or other purposes permitted by law, but are no longer required for these purposes, may be ethically acceptable if:

  • The ova and sperm from which they are formed were obtained in accordance with the G-TCPS2
  • Consent was provided by the gamete donors
  • Embryos exposed to manipulations not directed specifically to their ongoing normal development will not be transferred for continuing pregnancy
  • Research involving embryos will take place only during the first 14 days after their formation by combination of the gametes, excluding any time during which embryonic development has been suspended

Per the G-TCPS2, research involving a fetus or fetal tissue:

  • Requires the consent of the woman
  • Must not compromise the woman’s ability to make decisions regarding continuation of her pregnancy

In accordance with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Required Elements section. Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

4.8
Information on ICH guidelines implemented by Health Canada and Efficacy Guidelines
Chapter 4 (Article 4.3) and Chapter 12 (Articles 12.6-12.9)
Last content review/update: February 9, 2024

The G-CTChldrnWmn states that data supporting the conduct of a clinical trial involving pregnant/lactating women should demonstrate that the benefit to the population outweighs the risk. For interventions or procedures that have no potential individual benefits for pregnant/lactating women:

  • The risks must be minimized and no more than minimal;
  • The purpose of the research must be to obtain knowledge relevant to the particular health needs of the population;
  • The social value of the research for the pregnant/lactating women is compelling, and the research cannot be conducted in any other population; and
  • Any research-related risk is the least possible for achieving the objectives of the research

According to the G-CTChldrnWmn, legally valid consent should be obtained from the participant or spouse as appropriate and in line with the NGHRP. As per the NGHRP, any Ugandan clinical studies involving pregnant women and fetuses require additional safeguards to ensure that the research conforms to appropriate ethical standards and upholds societal values. Informed consent should be obtained from both the mother and father of the embryos and fetuses. However, the father's consent is not required if: (i) the purpose of the study is primarily to meet the mother's health needs; (ii) the father's identity and/or whereabouts are unknown; (iii) the father is not reasonably available; or (iv) the pregnancy resulted from rape or incest and (v) the father is incompetent to give consent.

The G-CTChldrnWmn further indicates that for clinical trials involving pregnant women that have the potential for harm to the fetus, the participant should be informed about the potential risks, and research should be conducted only after assessing that the benefits (to the mother or fetus, as appropriate) outweigh the risk involved, and with informed consent of the participants.

(See the Required Elements section for general informed consent form requirements.)

3 and 4.1
5.7
Last content review/update: October 1, 2024

According to the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

1.61
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Chapter 3 (Article 3.1) and Chapter 4 (Article 4.7)
Last content review/update: February 9, 2024

The G-TrialsGCP states that residents of prisons are often considered vulnerable because in a confined setting, they have few options and are denied certain freedoms that non-institutionalized persons enjoy. Some individuals with this characteristic may also have diminished capacity to consent, and therefore require the additional protections for participants who lack decisional capacity.

Institutional ethics committees (ECs) (research ethics committees (RECs) in Uganda) must review the need for special protection of the rights and welfare of these vulnerable populations and include protections when necessary.

2.3

Mentally Impaired

Last content review/update: October 1, 2024

According to the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), the ethics committee (EC) (known as Research Ethics Board in Canada) must approve the participation of research participants who are mentally or physically incapable of giving consent. Per CAN-50, Canada has implemented CAN-52.

Per CAN-35, adults with diminished decision-making capacity include:

  • Individuals whose decision-making capacity remains only partially developed, such as those living with permanent cognitive impairment, and
  • Individuals who once were capable of making an autonomous decision regarding consent but whose decision-making capacity is diminishing or fluctuating (e.g., due to cognitive impairment resulting from an injury or disease).

Per CAN-35, as is the case for any vulnerable population, care must be taken to ensure that adults with diminished decision-making capacity are not inappropriately included in research because of their situation, and neither should they be excluded from participating in research that may benefit them.

The G-TCPS2 indicates that for research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the EC must ensure that, at a minimum, the following conditions are met:

  • The researcher involves participants who lack the capacity to decide on their own behalf to the greatest extent possible in the decision-making process
  • The researcher seeks and maintains consent from the participant’s legal representative/guardian in accordance with the best interests of the persons concerned
  • The legal representative/guardian is not the researcher or any other member of the research team
  • The researcher demonstrates that the research is being carried out for the participant’s direct benefit, or for the benefit of other persons in the same category; if the research does not have the potential for direct benefit to the participant but only for the benefit of the other persons in the same category, the researcher shall demonstrate that the research will expose the participant to only a minimal risk and minimal burden, and demonstrate how the participant’s welfare will be protected throughout the participation in research
  • When authorization for participation was granted by a legal representative/guardian, and a participant acquires or regains decision-making capacity during the course of the research, the researcher must promptly seek the participant’s consent as a condition of continuing participation

Per CAN-35 and the G-TCPS2, the participant’s legal representative/guardian can provide consent for adults who lack the capacity to decide on their own behalf in accordance with the best interests of the persons concerned. In such cases, participants should still be involved to the greatest extent possible in the decision-making process, and their assent to participate must be obtained if they are capable of expressing their wishes in a meaningful way (whether verbally or physically). Importantly, when authorization for participation was granted by the participant’s legal representative/guardian and a participant acquires or regains decision-making capacity during the course of the research, the researcher must promptly seek the participant’s consent as a condition of continuing participation.

Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

1.61 and 3.1
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
Consent Process (Key Considerations)
Chapter 3 (Article 3.7-3.10)
Last content review/update: February 9, 2024

The G-TrialsGCP states that residents of mental institutions are often considered vulnerable because in a confined setting, they have few options and are denied certain freedoms that non-institutionalized persons enjoy. Some individuals with this characteristic may also have diminished capacity to consent, and therefore require the additional protections for participants who lack decisional capacity.

Institutional ethics committees (ECs) (research ethics committees (RECs) in Uganda) must review the need for special protection of the rights and welfare of these vulnerable populations and include protections when necessary.

2.3

Definition of Investigational Product

Last content review/update: October 1, 2024

As delineated in the CanadaFDR, the G-GMP-Annex13, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), an investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form. Per CAN-50, Canada has implemented CAN-52. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

1.33
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
3.0
5.1
Part C (Division 5 (C.05.001))
Last content review/update: February 9, 2024

As delineated in the NGHRP, the NDPA-CTReg, the G-CTConduct, the G-GMPMedicinalAnnexes, and the G-TrialsGCP, an investigational product (IP) is defined as a pharmaceutical form of an active ingredient or a placebo being tested or used as a reference in a clinical trial. Per the G-GMPMedicinalAnnexes, the G-CTConduct, and the G-TrialsGCP, an IP is also referred to as an investigational medicinal product (IMP) in Uganda and includes:

  • A product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form
  • When used for an unapproved indication
  • When used to gain further information about an approved use
2.0
Annex 13 (Glossary to Annex 13)
1.1
Glossary
Part I (2)

Manufacturing & Import

Last content review/update: October 1, 2024

Manufacturing

As specified in the CanadaFDR, the G-CanadaCTApps, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), Health Canada (HC) authorizes the manufacture of investigational products (IPs) in Canada. HC approves the manufacture of IPs as part of the clinical trial application (CTA) approval. Per CAN-50, Canada has implemented CAN-52. Note that per CAN-50, HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. The G-QCM-PharmCTAs provides guidance and templates to assist sponsors in completing the quality portion of the CTA, which in turn, enables HC to assess IP characteristics adequately. The G-GMP-Annex13 requires the sponsor to ensure that IPs for clinical trials are manufactured and imported in accordance with its provisions and with CanadaFDR requirements. Per the G-CanadaCTApps, sponsors must file amendments or notifications to a previously authorized CTA when manufacturing changes are proposed that may affect the quality or safety of the clinical trial drug or biologic supplies.

Import

Per the CanadaFDR and the G-FDR-0100, HC authorizes the sponsor to import an IP. A sponsor who is not based in Canada must have a Canadian representative who is responsible for the import of the IP and demonstrates compliance with the applicable regulatory requirements. This representative should be the sponsor’s senior medical or scientific officer residing in Canada and is responsible for providing an attestation with respect to the CTA at the time of filing. Per the G-CanadaCTApps, the G-DrugApp, and CAN-4, if clinical trial drugs are to be imported into Canada, the authorization template (Appendix 1) in CAN-4 should be completed and submitted for each importer in Canada. The G-DrugApp states that Canadian importer(s) must be located within Canada. As additional importers are identified, additional copies of the authorization template in CAN-4 should be provided to HC. The G-FDR-0100, provides additional guidance on requirements if a sponsor plans to send the clinical trial IP(s) directly to each trial site:

  • Each party, including individual Canadian clinical trial sites, importing drugs directly (i.e., receiving drug shipment directly from outside of Canada) is identified on Appendix 1 of the Drug Submission Application Form (HC/SC 3011 form) (CAN-4) for Phase I-III trials (submitted with the application if known at the time or prior to importation at the site). Appendix 1 may be replicated as many times as necessary to capture all importing parties.
  • Clinical Trial Site Information (CTSI) forms (CAN-6) for each Canadian site conducting the clinical trial are submitted to HC for Phase I-III trials, prior to the start of the study.
  • Systems are in place, when appropriate, to monitor the transportation and storage conditions from the foreign source to the various clinical trial sites across Canada.
  • There is documented accountability of the imported drugs used in clinical trials and distributed to various clinical trial sites located in Canada, including the disposition of drugs returned from the clinical trial sites.
  • A written agreement is in place between the sponsor and the qualified investigator describing their specific responsibilities, and this agreement is available at the clinical trial site.
  • There is evidence that the drugs used in clinical trials conducted in Canada meet Good Manufacturing Practice (GMP) requirements (e.g., certificates of manufacture, certificates of analysis, and/or evidence of approved lot release by a qualified individual).

The G-CanadaCTApps, the G-HlthProdImprtExptReqs, the G-FDR-0100, and CAN-32 state that if a sponsor wants to import a drug into Canada for a clinical trial, a copy of HC’s authorization (i.e., the No Objection Letter (NOL)) issued by either the Pharmaceutical Drugs Directorate (PDD) or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) must be included for the applicable trial with the shipment. A copy of this authorization must be provided at the port of entry. The G-HlthProdImprtExptReqs states that drugs without a Drug Identification Number may be imported where authorized for a Canadian clinical trial and a NOL was issued. The G-FDR-0100 further states that if 30 days have passed and the NOL was not issued, specific requests to import IPs should be directed to the Health Product Border Compliance Program at the following email account: hc.hpbcp-pcpsf.sc@canada.ca. Note that a sponsor does not have to submit a CTA for authorization to import an IP used in a Phase IV clinical trial.

Per CanadaFDR, the sponsor can make the following changes to the authorized use or importation of drugs if the sponsor notifies HC in writing within 15 days after the date of the change:

  • A change to the chemistry and manufacturing information that does not affect the quality or safety of the drug
  • A change to the protocol that does not alter the risk to the health of a clinical trial subject

Other changes must follow the amendment requirements delineated in the CanadaFDR. See the G-FDR-0100 for additional HC interpretations of the relevant provisions of the CanadaFDR.

Appendix 1
2.12 and 5.13
Drug Importation
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
1.0
2.3 and 2.7
5.2-5.3 and 5.6
I, S Drug Substance, and P Drug Product
Section # Block D and Appendix 1 Guidance
Importer’s Role, Table 1, and Human Drugs
Part C (Divisions 2-5)
Last content review/update: February 9, 2024

Manufacturing

According to the NDPA-CTReg, the G-CTConduct, and the G-TrialsGCP, the National Drug Authority (NDA) is responsible for authorizing the manufacture of investigational products (IPs) in Uganda. The NDA will only approve the manufacture of an IP after approval of the clinical trial application. The NDPA-CTReg indicates that if the IP is to be manufactured in Uganda, the holder of the clinical trial certificate must apply to the NDA for a manufacturing license.

Uganda follows the G-GMPMedicinal, the G-GMPMedicinalAPIs, and the G-GMPMedicinalAnnexes for good manufacturing practice (GMP), which were adopted from Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidance. Per the G-GMPMedicinal, the holder of the NDA’s manufacturing authorization must manufacture IPs to ensure that they are fit for their intended use, comply with the requirements of the clinical trial authorization, and do not place participants at risk due to inadequate safety, quality, or efficacy. The G-GMPMedicinalAnnexes further states that for manufacturers to be able to apply, and comply with, GMP for IPs, cooperation between manufacturers and sponsors of clinical trials is required. This cooperation should be described in a technical agreement between the sponsor and manufacturer.

The G-GMPMedicinalAPIs indicates that when manufacturing active pharmaceutical ingredients (APIs) for use in clinical trials, process and test procedures should be flexible to provide for changes as knowledge of the process increases and clinical testing of a drug product progresses from pre-clinical stages through clinical stages. Once drug development reaches the stage where the API is produced for use in IPs, manufacturers should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API. Additionally, the manufacture of APIs for use in clinical trials should be documented in laboratory notebooks, batch records, or by other appropriate means.

See the G-GMPMedicinal, the G-GMPMedicinalAPIs, and the G-GMPMedicinalAnnexes for more detailed manufacturing requirements.

Import

The NDA is responsible for authorizing the import of IPs. The NDPA-CTReg and the G-CTConduct state that prior to IP import or manufacture, the sponsor or principal investigator (PI) must be granted a clinical trial certificate by the NDA. According to the NDPA-CTReg, the holder of the clinical trial certificate must then apply for a permit to import the IP approved for the trial.

According to the G-VerImprtExprt, an application for an import verification certificate under extraordinary circumstances (which include clinical trials approved by the NDA) must be submitted electronically through the National Drug Authority Management Information System (NDAMIS) (UGA-34) by a person duly authorized to import drugs into Uganda (an import license holder). The G-VerImprtExprt includes clinical trials approved by the NDA in its definition of “extraordinary circumstances.” The application should be accompanied by:

  • A clinical trial certificate for drugs for use in clinical trials
  • A copy of the proforma invoice from the supplier
  • A donation certificate, if applicable
  • Authorization for drugs to be used in a medical camp, if applicable
  • Evidence of current GMP compliance of the manufacturer. The manufacturer should have GMP certification issued by the NDA, or the national medicines regulatory authorities of the following countries/regions: the United States of America (USA), the European Union (EU), the United Kingdom (UK), Switzerland, Canada, Australia, Iceland, Liechtenstein, Norway, or prequalified by the World Health Organization
  • Documented evidence/justification describing the emergency or extraordinary circumstance
  • A filled application form for the authorization for importation of narcotic drugs and psychotropic substances and precursors, if applicable
  • Evidence of registration of the drug(s) in the country of origin or emergency use approval of the drug by the competent authority in the country of origin, by a supranational body and any other regulatory authority if not registered

As stated in the G-VerImprtExprt, the application is screened for completion and correctness, then the applicant is billed the prescribed fees (see the NDPA-FeesReg for more information). The NDA will issue a verification certificate upon receipt of a successful application. The verification certificate is valid for 12 months from the date of issue.

See the G-VerImprtExprt for detailed import permit application submission requirements and review procedures. Additionally, see the Submission Process, Submission Content, and Regulatory Fees sections for detailed clinical trial application requirements.

Please note: Uganda is party to the Nagoya Protocol on Access and Benefit-sharing (UGA-3), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see UGA-21.

10.0-10.2
Terms and Definitions, 11.0, and 14.0
4.15
Annex 13 (Introduction)
Introduction and Chapters 1 and 4
19
Part II (9) and Schedule 1 (Form 30)

Quality Requirements

Last content review/update: October 1, 2024

Investigator’s Brochure

In accordance with the CanadaFDR and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB). The CanadaFDR and CAN-52 specify that the IB must contain all of the relevant information on the investigational product(s) (IPs), including significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information. The sponsor must ensure that an up-to-date IB is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

The CanadaFDR and CAN-52 require the IB to provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
  • Summary of data and guidance for the investigator(s)

See Section 7.3 of CAN-52 for detailed content guidelines.

In accordance with the G-CanadaCTApps and CAN-22, the sponsor must submit annually to HC an updated IB, which serves as the annual report, including all safety information and global status. Revisions that are more frequent may be appropriate depending on the stage of development and the generation of relevant new information.

Quality Management

Pursuant to CAN-52, the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial. As specified in CAN-52, G-GMP-CAN, and G-GMP-Annex13, the sponsor must ensure that the products are manufactured in accordance with Good Manufacturing Practice (GMP). The G-GMP-CAN requires a quality management system, incorporating GMP, to ensure that IPs are of the quality required for their intended use. Per the G-GMP-Annex13, the manufacturer’s quality system should be described in written procedures and available to the sponsor, taking into account GMP principles and guidelines.

2.12, 5.13, 7.3, and 8.2
Information on ICH guidelines implemented by Health Canada and Efficacy guidelines
4
4
2.8
5.1, 5.5, and 5.12
Part C (Division 5 (C.05.001, C.05.005, and C.05.012))
Last content review/update: February 9, 2024

Investigator's Brochure

In accordance with the NDPA-CTReg, the sponsor is responsible for updating the Investigator’s Brochure (IB), which is a compilation of the clinical and non-clinical data on the investigational product(s) (IPs). The G-TrialsGCP further indicates that the IB should be reviewed at least annually and revised as necessary in compliance with a sponsor's written procedures. Relevant new information may be so important that it should be communicated to the investigator(s), and possibly to the institutional ethics committee(s) (ECs) (research ethics committees (RECs) in Uganda) and/or regulatory authorities, before it is included in a revised IB.

According to the G-TrialsGCP, the sponsor is generally responsible for ensuring that an up-to-date IB is made available to the investigator(s), and the investigators are responsible for providing the up-to-date IB to the responsible ECs and the National Drug Authority (NDA). In the case of an investigator sponsored trial, the sponsor-investigator should determine whether a brochure is available from the commercial manufacturer. If the IP is provided by the sponsor-investigator, then the sponsor-investigator should provide the necessary information to the trial personnel. In cases where preparation of a formal IB is impractical, the sponsor-investigator should provide, as a substitute, an expanded background information section in the trial protocol that contains the minimum current information described in this guideline.

The G-TrialsGCP, the NDPA-CTReg, and UGA-4 require the IB to provide coverage for the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and post-marketing experiences)
  • Summary of data and guidance for the investigator(s)

See Section 7.3 of the G-TrialsGCP for detailed content descriptions, and UGA-4 or Schedule 2 of the NDPA-CTReg for the format of the IB.

Quality Management

Uganda follows the G-GMPMedicinal, the G-GMPMedicinalAPIs, and the G-GMPMedicinalAnnexes for good manufacturing practice (GMP), which were adopted from Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidance. Per the G-GMPMedicinal, GMP ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the clinical trial authorization. The forementioned documents must be used for periodic GMP inspection of all manufacturers of medicinal products within and outside Uganda whose products are registered or subjected to registration in the country. Manufacturers that are GMP compliant will be issued GMP compliance certificates.

According to the G-CTConduct and the G-TrialsGCP, the sponsor must ensure that the IP(s) is manufactured in accordance with GMP. The G-CTConduct further indicates that evidence of manufacture under GMP standards must be submitted with the clinical trial application to the NDA. In cases where the sponsor or the PI is not the manufacturer, and where confidentiality considerations prevent disclosure of certain information to the sponsor or the PI, any relevant IP/application information should be submitted to the NDA through the sponsor or the PI in a sealed envelope marked “CONFIDENTIAL.” Alternatively, the information may be sent to the Clinical Trials Unit with the necessary password protection at clinicaltrials@nda.or.ug.

The G-TrialsGCP states that if significant formulation changes are made in the investigational or comparator product(s) during the course of clinical development, the results of any additional studies of the formulated product(s) (e.g., stability, dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the pharmacokinetic profile of the product should be available prior to the use of the new formulation in clinical trials and submitted to the NDA for review and authorization.

According to the G-GMPMedicinalAnnexes, the manufacturer should establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production. Quality control of the IP, including that of the comparator product, should be performed in accordance with the information submitted in the application for the clinical trial. See the G-GMPMedicinal and the G-GMPMedicinalAnnexes for more information on quality control requirements.

Additionally, the G-GMPMedicinalAnnexes indicates that a pharmaceutical quality system which is designed, set up, and verified by the manufacturer should be described in written procedures, taking into account the guidance in the G-GMPMedicinal that is applicable to IPs. The product specifications and manufacturing instructions may be changed during development, but full control and traceability of the changes should be documented and maintained. The selection, qualification, approval, and maintenance of suppliers of starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system to ensure the integrity of the supply chain and protect against falsified products. The product specification file should be continually updated as development of the product proceeds, ensuring appropriate traceability to the previous versions. It should include, or refer to, at least the following documents:

  • Specifications and analytical methods for starting materials, packaging materials, intermediate product, bulk product, and finished product
  • Manufacturing methods
  • In-process testing and methods
  • Approved label copy
  • Relevant clinical trial authorizations and amendments thereof, clinical trial protocol, and randomisation codes, as appropriate
  • Relevant technical agreements with contract givers and acceptors, as appropriate
  • Stability plan and reports
  • Details of plans and arrangements for reference and retention samples
  • Storage and transport conditions
  • Details of the supply chain including manufacturing, packaging, labeling, and testing sites for the IPs

For more information on pharmaceutical quality system requirements, see the G-GMPMedicinal and the G-GMPMedicinalAnnexes.

4.6, 10.2, and 10.5
4.15 and 7.0-7.3
Annex 13 (2 and 7)
Introduction and Chapters 1 and 4
Part I (2), Part III (15 and 18), and Schedule 2 (Format for Investigator’s Brochure)
Last content review/update: October 1, 2024

Investigational product (IP) labeling in Canada must comply with the requirements set forth in the CanadaFDR, the G-CanadaCTApps, the G-GMP-Annex13, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52). The CanadaFDR and the G-CanadaCTApps state that for an IP to be used in a clinical trial, it must be properly labeled in both official languages: English and French. The CanadaFDR requires that IPs be packaged and labelled under the supervision of personnel who have had satisfactory technical, academic, and other training. The packager and/or labeler must have written procedures and ensure that the IP is packaged, labelled, and tested in compliance with those procedures. For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. Per CAN-50, Canada has CAN-52.

As delineated in the CanadaFDR and the G-GMP-Annex13, the following information must be included on the IP label:

  • A statement indicating that the drug is an investigational drug to be used only by a qualified investigator
  • Name, number, or identifying mark
  • Expiration date
  • Recommended storage conditions
  • Lot number
  • Sponsor’s name and address
  • Protocol code or identification
  • Radiopharmaceutical information, if applicable

With regard to the expiration date, the G-GMP-Annex13 further states that if it becomes necessary to change the expiration date, an additional label should be affixed to the IP. This additional label should state the new expiration date and repeat the batch number. It may be superimposed on the previous expiration date, but for quality control reasons, not on the original batch number. This operation should be performed at an appropriately authorized manufacturing site. However, when justified, it may be performed at the investigational site by or under the supervision of the clinical trial site pharmacist, or other health care professional in accordance with national regulations and with the sponsor’s requirements. Where this is not possible, it may be performed by the clinical trial monitor(s) who should be appropriately trained. The operation should be performed in accordance with good manufacturing practice (GMP) principles, specific and standard operating procedures and under contract, if applicable, and should be checked by a second person. This additional labelling should be properly documented in both the trial documentation and in the packaging records.

In addition, CAN-52 state that the IP must be coded and labeled in a manner that protects the blinding, if applicable.

5.13
Efficacy guidelines
8.7
2.8.7
5.11
Part C (Divisions 2 (C.02.006, C.02.011, C.02.015-016) and 5 (C.05.011))
Last content review/update: February 9, 2024

Labeling for investigational products (IPs) (known as investigational medicinal products (IMPs) in Uganda) must comply with the requirements set forth in the G-GMPMedicinalAnnexes, the NDPA-CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP. As specified in the G-GMPMedicinalAnnexes, the labeling operation should be performed at an authorized manufacturing site.

As per the NGHRP and the G-TrialsGCP, the sponsor is responsible for ensuring the proper labeling of the IPs. The IPs and comparator products must be labeled in conformity with the clinical protocol.

According to the NDPA-CTReg and the G-CTConduct, the IP must be labelled as specified in UGA-7 or Form 38 of the NDPA-CTReg. The NDPA-CTReg, the G-GMPMedicinalAnnexes, and UGA-7 require the following labeling information to be included on both the outer packaging and the immediate container (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

  • The name, address, and telephone number of the sponsor or manufacturer; the G-GMPMedicinalAnnexes specifies the investigator or contract research organization could also be the main contact for IP information, clinical trial, and emergency unblinding
  • The name/identifier and strength/potency, and in the case of blinded trials, all product labeling should indicate “placebo/comparator or [name/identifier] + [strength/potency]”
  • The pharmaceutical dosage form, route of administration, and quantity of dosage units
  • The batch and/or code number to identify the contents and packaging operation
  • A trial reference code allowing identification of the trial, site, investigator, and sponsor, if not given elsewhere
  • The trial participant identification number or treatment number and, where relevant, the visit number
  • The investigator’s name (if not already provided on the label)
  • The storage conditions
  • Pack sizes (unit or volume)
  • The instructions for use
  • The period of use (use-by date, expiration date, manufacturing date, or re-test date), in month/year format
  • “For clinical trial use only” or similar wording
  • “Keep out of reach of children” except when the IP is for use in trials where it is not taken home by participants

The G-GMPMedicinalAnnexes further states that where products are blinded, systems should be in place to ensure that the blind is achieved and maintained while allowing for identification of “blinded” products, when necessary, including batch numbers of the products before the blinding operation. Rapid identification of the product should also be possible in an emergency. Where the manufacturer has been delegated the responsibility for generation of randomization codes, the manufacturer should ensure that unblinding information is available to the appropriate responsible investigator site personnel before the IPs are supplied. The expiry date assigned to all products for use in the trial should be the expiry of the shortest dated product so that the blinding is maintained.

For additional detailed labeling information and exceptions, see the G-GMPMedicinalAnnexes.

The G-TrialsGCP requires that in blinded trials, the coding system for IPs should include a mechanism that permits rapid identification of the products in case of a medical emergency, but does not permit undetectable breaks of the blinding. The G-CTConduct further indicates that a sample of the label for imported products must be included with the clinical trial application to the National Drug Authority (NDA).

4.6, 10.3, and Appendix I
Annex 13 (6.4 and 6.6)
4.15
7.2
Part III (17) and Schedule 1 (Form 38)

Product Management

Last content review/update: October 1, 2024

Supply, Storage, and Handling Requirements

Per CanadaFDR, drugs must be manufactured, handled, and stored in accordance with good manufacturing practice (GMP). As defined in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor must supply the investigator(s) with the investigational products (IP(s)), including the comparator and placebo, if applicable. The sponsor should not supply the IP(s) until approvals from Health Canada (HC) and the institutional ethics committee (EC) are obtained. CAN-52 specifies that the sponsor must ensure the following:

  • Timely delivery of the IP(s)
  • Records maintained for IP document shipment, receipt, disposition, return, and destruction
  • Written procedures including instructions for IP handling and storage, adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • IP product quality and stability over the period of use
  • IP manufactured according to any application of GMP
  • Proper coding, packaging, and labeling of the IP(s)
  • Acceptable IP handling and storage conditions and shelf-life

For IP packaging, the G-GMP-Annex13 provides the following guidance:

  • The risk of product mix up must be minimized by using appropriate procedures, specialized equipment, and relevant staff training.
  • To prevent errors, particularly when IPs are blinded, use heightened precautions, such as label reconciliation, line clearance, and in-process control checks by appropriately trained staff.
  • The packaging must ensure that the IP remains in good condition during transport and storage at intermediate destinations; any opening or tampering of the outer packaging during transport should be readily discernible.

The G-Storage provides principles and interpretations on the environmental control of clinical trial drugs during storage and transportation, including packaging. See G-Storage for information regarding compliance with the CanadaFDA and the CanadaFDR, as it relates to packaging clinical trial drugs for human use, such as the role of environmental controls, quality risk management, and special considerations for active pharmaceutical ingredients. In addition, CAN-52 state that the IP must be packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. Refer to CAN-52 for detailed sponsor-related IP requirements.

Record Requirements

As set forth in the CanadaFDR, the G-FDR-0100, and the CanadaFDR1024, the sponsor must record, handle, and store all trial-related information to allow complete and accurate reporting, interpretation, and verification. The CanadaFDR states that the sponsor should maintain all trial-related records for a period of 15 years. Pursuant to CanadaFDR1024, the sponsor must submit requested records to HC within 48 hours if safety concerns arise. Additionally, to facilitate inspection of a site, the sponsor must submit information to HC within seven (7) days of a request.

The G-Storage provides that when contracted parties, such as warehouses or commercial carriers, store or transport drugs, there should be a written agreement that outlines all relevant conditions.

5.5, 5.12, 5.13, 5.14, and 7
Efficacy guidelines
8.6
5.1, 5.5, 5.10, and 5.12
Regulatory Impact Analysis Statement
Part C (Division 5 (C.05.001, C.05.005, C.05.010, and C.05.012))
Last content review/update: February 9, 2024

Supply, Storage, and Handling Requirements

As delineated in the G-TrialsGCP and the G-CTConduct, the sponsor must ensure timely delivery of the investigational product(s) (IP(s)) to the principal investigator (PI)/investigator(s). Additionally, the sponsor must maintain sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary. The G-TrialsGCP further states that the sponsor should not supply the investigator(s)/institution(s) with the IP(s) until the sponsor obtains National Drug Authority (NDA) and institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approvals. However, according to the NDPA-CTReg, the PI is responsible and accountable for the IP.

Furthermore, per the G-TrialsGCP, the sponsor should ensure that written procedures include instructions that the investigator/institution should follow for the handling and storage of IP(s) for the trial and documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from participants, and return of unused IP(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the NDA approved protocol and/or where available, applicable regulatory requirement(s)).

As delineated in the G-GMPMedicinalAnnexes, IPs are normally packed individually for each participant included in the clinical trial. The number of units to be packaged should be specified prior to the start of the packaging operations, including units necessary for carrying out quality control and for any retention samples to be kept. Sufficient reconciliations should take place to ensure that the correct quantity of each product required has been accounted for at each stage of processing. Procedures should describe the specification, generation, testing, security, distribution, handling, and retention of any randomization code used for packaging IPs, as well as code-break mechanism. Appropriate records should be maintained.

Per the G-GMPMedicinalAnnexes, packaging must ensure that the IP remains in good condition during transport and storage at intermediate destinations. Any opening or tampering of the outer packaging during transport should be readily discernible. Where the manufacturer is delegated by the sponsor to perform the regulatory release of the IP, the arrangements should be defined in an agreement between the sponsor and the manufacturer. Relevant clinical trial authorization and amendment information should be available for reference in the product specification file, and the manufacturer should ensure the necessary clinical trial authorizations are in place prior to shipping the product for use in the trial.

Per the G-TrialsGCP and the G-CTConduct, the sponsor must also maintain a system for retrieving IP(s), as well as for the disposal of unused IP(s). The G-GMPMedicinalAnnexes further delineates that returned IPs should be clearly identified and stored in an appropriately controlled, dedicated area. The manufacturer or sponsor’s representative should destroy IPs only with prior written authorization by the sponsor. The arrangements for destruction of IPs must be described in the protocol. Any arrangement between sponsor and manufacturer regarding IP destruction should be defined in their technical agreement. Destruction of unused IPs should be carried out only after reconciliation of delivered, used, and recovered products and after investigation and satisfactory explanation of any discrepancies upon which the reconciliation has been accepted.

See the G-GMPMedicinalAnnexes, the G-TrialsGCP, and the G-CTConduct for detailed sponsor-related IP requirements.

Record Requirements

As per the G-CTConduct and the G-TrialsGCP, the sponsor must maintain records that document shipment, receipt, disposition, return, and destruction of the IP(s). The sponsor must also maintain a system for documenting the retrieval of IP(s) and the disposal of unused IP(s), as well as records of batch sample analyses and characteristics.

Per the G-GMPMedicinalAnnexes, there must be sufficient documentation to demonstrate that appropriate segregation has been maintained during any IP packaging operations. To facilitate a recall of the IP, a detailed inventory of the shipments made by the manufacturer should be maintained. Inventory records of returned IPs should be kept. Additionally, records of destruction operations should be retained, including a dated certificate of destruction or a receipt for destruction to the sponsor. These documents should clearly identify or allow traceability to the batches and/or participant numbers involved, and the actual quantities destroyed.

The G-CTConduct indicates that the pharmacist of record must maintain instructions for the handling of IP(s) and trial related materials, if not indicated in the protocol or Investigator’s Brochure (IB). The pharmacist must also maintain shipping records for the IP(s) and trial related material, as well as for receipt date(s) of product delivery and quantity.

According to the G-GMPMedicinalAnnexes, product specification file documents must be retained for at least five (5) years, and the sponsor should retain the clinical trial master file for at least 25 years after the end of the trial, unless otherwise specified in relevant national laws. If the sponsor and the manufacturer are not the same entity, the sponsor must make appropriate arrangements with the manufacturer to fulfil the clinical trial master file retention requirement. Arrangement for retention of such documents and the type of documents to be retained should be defined in an agreement between the sponsor and manufacturer. Per the G-GMPMedicinal to the G-GMPMedicinalAnnexes,, batch documentation/manufacturing records must be retained by the manufacturer for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the batch was used.

10.5
Chapter 4
Annex 13 (5, 6.5, 8, and 11)
4.14-4.16
Part III (15-16 and 18)

Definition of Specimen

Last content review/update: July 26, 2024

In Canada, a specimen is referred to as “human biological material” or “biological material.” According to the G-TCPS2, human biological materials include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids. The term also comprises materials related to human reproduction, including embryos, fetuses, fetal tissues, and human reproductive materials. The G-TCPS2 breaks down human biological material further into the following categories: anonymized, anonymous, coded, and identified human biological materials. Refer to the G-TCPS2 for more detailed information on these categories.

In addition, CAN-2 defines biological material as pathogenic and non-pathogenic microorganisms, proteins, and nucleic acids, as well as any biological matter that may contain microorganisms, proteins, nucleic acids, or parts thereof. Examples include, but are not limited to, bacteria, viruses, fungi, prions, toxins, genetically modified organisms, nucleic acids, tissue samples, diagnostic specimens, live vaccines, and isolates of a pathogen (e.g., pure culture, suspension, purified spores).

Glossary
Chapter 12 and Glossary
Last content review/update: February 9, 2024

In Uganda, a specimen is also referred to as human material. As delineated in the NGHRP, human biological materials consist of any substance obtained from a human research participant. This material includes, but is not limited to: blood, urine, stool, saliva, hair, nail clippings, skin, microorganisms, and other associated bio-products.

10.0

Specimen Import & Export

Last content review/update: July 26, 2024

Import/Export

According to the G-HlthProdImprtExptReqs, Health Canada (HC) does not have jurisdiction over human biological materials to be imported for testing or research purposes. The G-HlthProdImprtExptReqs further states that all blood samples as well as cultures, diagnostic specimens, or research tissue are considered to be potential carriers of human or animal pathogens, and are regulated by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA). Per CAN-24, CAN-2, and CAN-9, the PHAC’s Centre for Biosecurity oversees the licensing process under the authority of the HPTA and the HPTR. The HPTA states that a license must be issued by the Minister that authorizes the import or export of human pathogens or toxins.

As specified in the HPTA, the HPTR, and CAN-2, individuals planning to conduct controlled activities (including producing, possessing, handling, using, storing, providing access to, transferring, disposing of, releasing, abandoning, or importing/exporting) with a human pathogen or toxin, whether imported or domestically acquired, must obtain a license. Per CAN-2, because all human biological materials are potential carriers of human pathogens, the PHAC has categorized these materials by risk group based on risk to the individual/animal and risk to the community. Risk Group 1 consists of microorganisms, nucleic acids, or proteins that are unable or unlikely to cause human or animal disease so they are generally not considered to be pathogens, and are therefore exempt from the HPTA and the HPTR licensing requirements. Risk groups 2 through 4 are considered to be pathogens or toxins with moderate to high individual risk and low to high community risk, and are subject to the HPTA and the HPTR licensing requirements. See CAN-2 and CAN-9 for detailed information and instructions on how to obtain a license for activities associated with Risk Groups 2 through 4.

Chapter 21
Chapters 1 and 2
Blood and blood components for transfusion
Purpose of the Act, Interpretation and Application, Obligation, Prohibitions, and Licenses
Licenses
Last content review/update: February 9, 2024

Import/Export

The G-CTConduct state that applications for import and/or export of biological materials, if applicable, must be included in the clinical trial application to the National Drug Authority (NDA).

Additionally, the NGHRP delineates that all exchanges and transfers, including importation and exportation of human materials for research purposes, require Uganda National Council for Science and Technology (UNCST) clearance, except for the exchange of human materials between organizations within Uganda. In order to justify transfer of human materials abroad, investigators, sponsors, and collaborators should demonstrate that in-country capacity to perform certain types of investigations/testing does not exist or is inadequate. Per the G-UNCSTreg, where it is proven that no capacity for a given investigation exists in Uganda, or where exchange of research material is needed for quality assurance purposes or other justifiable reasons, research materials may be transferred to, exported to, or exchanged with more advanced facilities abroad.

Per the NGHRP and the G-UNCSTreg, the following are the necessary steps for the exchange or transfer of human materials for research purposes abroad or from abroad:

  • The research project that involves the exchange or transfer of human material must first be registered by the UNCST
  • The applicant must be a legal resident of Uganda and be affiliated with a locally registered and recognized organization in Uganda
  • A request for exchange or transfer of human material must be made in writing to the Executive Secretary of the UNCST
  • A Material Transfer Agreement (MTA) and any other document related to the exchange or transfer of human material must accompany the request for the exchange or transfer of the material

According to the NGHRP, the UNCST is required to provide feedback within 14 calendar days from the submission date. However, the G-UNCSTreg states that the UNCST must provide feedback within 10 working days from the submission date. The feedback may be an approval or clearance, a rejection or disapproval, or comments to improve the quality of the application. Once the UNCST approval is obtained, the investigator can proceed to facilitate the transfer, export, or exchange of the research specimen.

Material Transfer Agreement

As set forth in the NGHRP and the G-UNCSTreg, the UNCST application for permission to transfer, export, or exchange samples for research purposes from one (1) organization to another, within the country and abroad, must be accompanied by an MTA between the provider organization and the recipient organization. Per the NGHRP, the MTA should include the following details:

  • A list of the parties and their addresses; the MTA is signed only by authorized party representatives and the effective date of the MTA must be indicated
  • A detailed description of the materials to be exchanged
  • The purpose for transfer or export of the human biological substance
  • A list of authorized users of the materials
  • The location where the material is to be transferred
  • Period of use and disposal plans for the material
  • Clear arrangements for benefit sharing of any accruing or anticipated future benefit at the point of termination
  • The provider organization should state whether the recipient organization is permitted to own any of the derivatives or products discovered through the use of the material
  • Directions for handling product commercial rights
  • Publication requirements/restrictions, including citation requirements if information about the material is published
  • The governing law(s) of the provider’s and recipient’s countries
  • Recipient organization’s responsibilities for the proper handling and use of the material
  • Recipient and provider agreement on liability for any misuse of the material
  • Description of specific restrictions for the recipient organization
  • A statement indicating what technologies would be transferred to the provider organization or country, if applicable
  • A warranty stating that the material is being provided “as is”
  • A clause stating that the MTA may be amended at any time by written mutual consent of the parties

See Section 10.4 of the NGHRP for detailed MTA requirements. Per the UNCST-RevTemp, data ownership and associated intellectual property rights in both the Data Sharing Agreements and MTAs must be discussed and agreed upon by collaborating partners at the inception of a research study within the context of the investigator's institutional regulations/provisions. Templates of Data Sharing Agreements and MTAs, as applicable, must be presented as part of the research protocol to be reviewed by the institutional ethics committee (EC) (research ethics committee (REC) in Uganda).

See the G-Biobank for more information on the collection, receipt, storage, processing, and dissemination of biological specimens by biobanks in Uganda.

4.6 and Appendices I and II
15.0
10.0

Requirements

(Legislation) Food and Drugs Act (R.S.C., 1985, c. F-27) (CanadaFDA – English and French) (Last Amended June 20, 2024)
Parliament of Canada
(Legislation) Human Pathogens and Toxins Act (S.C. 2009, c. 24) (HPTA) (Last Amended January 14, 2023)
Parliament of Canada
(Legislation) Personal Information Protection and Electronic Documents Act (S.C. 2000, c.5) (PIPEDA) (Last Amended August 19, 2024)
Parliament of Canada
(Legislation) Privacy Act (R.S.C., 1985, P-21) (PrivAct) (Last Amended September 20, 2024)
Parliament of Canada
(Regulation) Food and Drug Regulations, (CRC, c. 870) (CanadaFDR – English and French) (Last Amended June 17, 2024)
Parliament of Canada
(Regulation) Human Pathogens and Toxins Regulations (SOR/2015-44) (HPTR) (Last Amended December 1, 2015)
Parliament of Canada
(Regulation) Regulations Amending the Food and Drug Regulations (1024 - Clinical Trials) (CanadaFDR1024 – English and French) (Effective September 1, 2001)
Parliament of Canada
(Guidance) Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines - Drugs Used In Clinical Trials (GUI 0036) (G-GMP-Annex13) (Effective December 1, 2009)
Health Canada
(Guidance) Filing Submissions Electronically (ElecSubms) (Last Updated June 17, 2024)
Health Products and Food Branch, Health Canada
(Guidance) Good Manufacturing Practices Guide for Drug Products (GUI 0001) (G-GMP-CAN) (Effective July 1, 2020)
Health Canada
(Guidance) Guidance Document - Development Safety Update Report (DSUR) - International Conference on Harmonisation (ICH) Topic E2F (G-DSUR) (Effective December 4, 2015)
Health Canada
(Guidance) Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications (G-CanadaCTApps) (Last Revised March 17, 2016)
Health Products and Food Branch, Health Canada
(Guidance) Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (G-FDR-0100) (Version 2) (Updated March 14, 2023)
Health Canada
(Guidance) Guidance Document: Preparation of Regulatory Activities in Non-eCTD Format (G-Non-eCTD) (Effective May 15, 2024)
Health Canada (*Note: Latest version available upon request. See Submission Process section for details)
(Guidance) Guidance Document: Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals (G-QCM-PharmCTAs) (Effective June 1, 2009)
Health Products and Food Branch, Health Canada
(Guidance) Guidance Document: The Management of Drug Submissions and Applications (G-MDSA) (Last Updated August 2, 2022)
Health Canada
(Guidance) Guidance for Completing the Drug Submission Application Form (G-DrugApp) (Last Updated March 31, 2021)
Health Canada
(Guidance) Guideline: Increasing Transparency when Presenting Safety Information in the Development Safety Update Report (DSUR): Region-Specific Requirements for Canada and the United Kingdom (G-DSUR-CanUK) (Last Updated July 6, 2021)
Health Canada
(Guidance) Guidelines for Environmental Control of Drugs During Storage and Transportation (GUI-0069) (G-Storage) (August 24, 2020)
Health Canada
(Guidance) How to Address Material Incidental Findings – Guidance in Applying TCPS2 (2018) Article 3.4 (G-ConsentMatIncFindings) (2019)
Panel on Research Ethics, Government of Canada
(Guidance) Importing and Exporting Health Products for Commercial Use (GUI-0117) (G-HlthProdImprtExptReqs) (Effective December 21, 2020)
Health Products and Food Branch, Health Canada
(Guidance) Policy Statement: Use of Pharmacometrics in Drug Submissions and Clinical Trial Applications (G-Pharmacometrics) (Last Updated March 31, 2021)
Health Canada
(Guidance) Preparation of Clinical Trial Applications for Use of Cell Therapy Products in Humans (G-CTACell) (August 21, 2015)
Health Canada
(Guidance) Quality Requirements for Investigational Biologic Drugs Used in Clinical Trials: Notice to Clinical Trial Sponsors (G-QltyBioCTs) (Last Updated July 23, 2024)
Health Canada
(Guidance) TCPS 2 Interpretations – Consent (TCPS2-InterpCnsnt) (Last Updated March 1, 2024)
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada
(Guidance) TCPS 2 Interpretations – REB Review (TCPS2-InterpReview) (Last Updated May 9, 2024)
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada
(Guidance) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (G-TCPS2) (December 2022)
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada
(Guidance) Validation Rules for Regulatory Transactions Provided to Health Canada in the Electronic Common Technical Document (eCTD) Format (Rules-eCTD) (January 30, 2024)
Health Canada
(Guidance) Validation Rules for Regulatory Transactions Provided to Health Canada in the Non-eCTD Format (Rules-Non-eCTD) (Version 5.2) (Effective May 1, 2024)
Health Canada
(Not Available Online) Common Electronic Submissions Gateway (CESG) Health Canada Reference Guide (Last Updated April 2022) (*Note: Only available upon request. See Submission Process section for details) (G-CESG)
(Not Available Online) Health Canada Guidance Document: Preparation of Regulatory Activities in the Electronic Common Technical Document (eCTD) Format (Effective March 13, 2020) (*Note: Latest version available upon request. See Submission Process section for details) (G-eCTD)
(Notice) Implementation of ICH E19: A Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials (HCNotice-ICH-E19) (Last Updated February 27, 2024)
Health Canada
(Notice) Update to Clinical Trial Site Information Form (HCNotice-CTSIForm) (Last Updated February 23, 2022)
Health Canada
(Notice) Update: Registration and Disclosure of Clinical Trial Information (HCNotice-CTRegDisc) (October 19, 2012)
Health Canada
(Legislation) National Drug Policy and Authority Act 1993, (Ch 206) (NDPA-Act) (December 3, 1993)
Parliament
(Legislation) The Data Protection and Privacy Act, 2019 (NITA-U-PrivAct) (May 3, 2019)
Parliament
(Legislation) The Uganda National Health Research Organisation Act, 2011 (UNHRO-Act) (June 10, 2011)
Parliament
(Legislation) Uganda National Council for Science and Technology Act 1990 – Chapter 209 (UNCST-Act) (June 1, 1990)
Parliament
(Regulation) The Data Protection and Privacy Regulations, 2021 (NITA-U-PrivReg) (March 12, 2021)
National Information Technology Authority - Uganda
(Regulation) The National Drug Policy and Authority (Conduct of Clinical Trials) (Amendment) Regulations, 2021 (NDPA-CTRegAmdt) (July 2, 2021)
Ministry of Health
(Regulation) The National Drug Policy and Authority (Conduct of Clinical Trials) Regulations, 2014 (S.I. 2014/32) (NDPA-CTReg) (March 28, 2014)
Ministry of Health
(Regulation) The National Drug Policy and Authority (Fees) Regulations, 2022 (S.I. 2022/5) (NDPA-FeesReg) (Effective March 1, 2022)
Ministry of Health
(Regulation) The National Drug Policy and Authority (Pharmacovigilance) (Amendment) Regulations, 2021 (NDPA-PVRegAmdt) (July 2, 2021)
Ministry of Health
(Regulation) The National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014 (S.I. 2014/37) (NDPA-PVReg) (March 28, 2014)
Ministry of Health
(Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority
(Guidance) Guidelines for the Provision of Insurance Cover for Research Participants in Clinical Trials in Uganda (G-InsuranceCover) (Effective October 14, 2019)
National Drug Authority
(Guidance) Guidelines on Good Clinical Practice in the Conduct of Clinical Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 3) (G-GMPMedicinalAnnexes) (Effective September 6, 2023)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 4) (G-GMPMedicinal) (Effective September 6, 2023)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part II – Basic Requirements for Active Pharmaceutical Ingredients (Revision No. 1) (G-GMPMedicinalAPIs) (Effective September 6, 2023)
National Drug Authority
(Guidance) Guidelines on the Conduct of Clinical Trials in Children, Pregnant and Lactating Women in Uganda (G-CTChldrnWmn) (Effective July 10, 2023)
National Drug Authority
(Guidance) Guidelines on the Verification of Applications for the Importation and Exportation of Drugs and Pharmaceutical Raw and Packaging Materials (Revision No. 1) (G-VerImprtExprt) (Effective September 6, 2023)
National Drug Authority
(Guidance) National Guidelines for Community Engagement in Research (NGCER) (February 2022)
Uganda National Council for Science and Technology
(Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
(Guidance) National Research Biobanking Guidelines (G-Biobank) (January 2021)
Uganda National Council for Science and Technology
(Guidance) Registration Classification and Guidance Note for Application for Registration/Renewal of Registration (PDPO-Note) (Version 1.3) (December 2021)
Personal Data Protection Office
(Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
(Circular) No. 009 - Certification of Premises Used to Supply Restricted Drugs within Institutions Conducting Clinical Trials (C-InstitutionCert) (February 27, 2018)
National Drug Authority
(Circular) No. 26 – Incomplete Clinical Trial Application Submissions (C-IncompleteCTA) (December 6, 2018)
National Drug Authority
(Correspondence) Request to Review Templates for Materials Transfer Agreements and Data Sharing Agreements (UNCST-RevTemp) (April 19, 2021)
Uganda National Council for Science and Technology

Additional Resources

(Document) Best Practices for Health Research Involving Children and Adolescents: Genetic, Pharmaceutical, and Longitudinal Studies (CAN-12) (2012)
Centre of Genomics and Policy and Maternal Infant Child and Youth Research Network
(Document) Canadian Biosafety Handbook (CAN-9) (Second Edition) (May 26, 2016)
Public Health Agency of Canada
(Document) Canadian Biosafety Standard (CBS) (CAN-2) (Third Edition) (Effective April 1, 2023)
Public Health Agency of Canada
(Document) Research Ethics Board’s Operational Policy Framework: Ethics Review of Research Involving Human Subjects (CAN-13) (Last Updated April 1, 2016)
Health Canada
(Document) University of Calgary CHREB Administration Fee for Industry Sponsored Protocols (CAN-3) (May 1, 2023)
University of Calgary, Research Services, Calgary, Canada
(International Guidance) A Selective Approach to Safety Data Collection in Specific Late-Stage in Specific Pre-Approval or Post-Approval Clinical Trials E19 (CAN-15) (Step 4 Version) (September 27, 2022)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials, E9 (R1) (CAN-39) (Step 5 Version) (November 20, 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) General Considerations for Clinical Studies E8(R1) (CAN-49) (Step 5 Version) (October 6, 2021)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) General Principles for Planning and Design of Multi-Regional Clinical Trials E17 (CAN-40) (Step 4 Version) (November 16, 2017)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (CAN-48) (Step 5 Version) (October 27, 1994)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (CAN-52) (Step 5 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) Statistical Principles for Clinical Trials ICH Topic E9: Guidance for industry (CAN-53) (Step 5 Version) (February 10, 2003)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Not Available Online) Health Canada – Clinical Trial Applications in eCTD format (September 2022) (*Note: Only available upon request. See Submission Process section for details) (CAN-36)
(Not Available Online) NIAID Communication with Health Canada (May 2024) (CAN-44)
(Webpage) Biologic and Radiopharmaceutical Drugs Directorate (CAN-17) (Last Updated December 19, 2022)
Health Products and Food Branch, Health Canada
(Webpage) Canadian Clinical Trials Asset Map (CCTAM) (CAN-26) (Current as of July 25, 2024)
Canadian Clinical Trials Coordinating Centre
(Webpage) Clinical Trials - Background (CAN-31) (Last Updated July 11, 2006)
Health Canada
(Webpage) Clinical Trials Drug Importation Frequently Asked Questions (CAN-32) (Last Updated July 11, 2006)
Health Products and Food Branch, Health Canada
(Webpage) ClinicalTrials.gov (CAN-45) (Current as of July 25, 2024)
US National Library of Medicine
(Webpage) Common Electronic Submissions Gateway (CAN-25) (Last Updated May 23, 2024)
Health Canada
(Webpage) Electronic Submissions Gateway (CAN-51) (Current as of July 11, 2024)
U.S. Food and Drug Administration
(Webpage) Filing of Clinical Trials Frequently Asked Questions (CAN-33) (Last Updated February 21, 2008)
Health Canada
(Webpage) Forms: Applications and Submissions for Drug Products (CAN-19) (Last Updated June 17, 2024)
Health Canada
(Webpage) Frequently Asked Questions - Common Electronic Submissions Gateway (CAN-28) (Last Updated January 17, 2020)
Health Canada
(Webpage) Health Portfolio (CAN-29) (Last Updated February 12, 2024)
Government of Canada
(Webpage) Health Products and Food Branch (CAN-16) (Last Updated June 24, 2022)
Health Products and Food Branch, Health Canada
(Webpage) How Drugs are Reviewed in Canada (CAN-23) (Last Updated February 12, 2015)
Health Canada
(Webpage) How to Use the Common Electronic Submissions Gateway to Send Regulatory Transactions to Health Canada (CAN-34) (Last Updated May 23, 2024)
Health Canada
(Webpage) Instructions for Completing the Clinical Trial Site Information Form (CAN-30) (Last Updated June 15, 2022)
Health Canada
(Webpage) International Council for Harmonisation (ICH) – Guidelines (CAN-50) (Last Updated February 27, 2024)
Health Canada
(Webpage) International Council for Harmonisation (ICH) – Health Canada Role in ICH (CAN-10) (Last Updated February 15, 2022)
Health Canada
(Webpage) ISRCTN Registry (CAN-46) (Current as of July 25, 2024)
ISRCTN Registry
(Webpage) Office of the Privacy Commissioner of Canada (CAN-42) (Last Updated June 6, 2024)
Office of Privacy Commissioner of Canada
(Webpage) Panel on Research Ethics – Navigating the Ethics of Human Research (CAN-14) (Last Updated July 22, 2024)
Panel on Research Ethics, Government of Canada
(Webpage) Pharmaceutical Drugs Directorate (CAN-18) (Last Updated March 26, 2024)
Health Products and Food Branch, Health Canada
(Webpage) Post-Authorization Requirements (CAN-22) (Last Updated February 5, 2009)
Health Canada
(Webpage) Provincial and Territorial Privacy Laws and Oversight (CAN-43) (Last Updated June 11, 2020)
Office of Privacy Commissioner of Canada
(Webpage) Public Health Agency of Canada – Licensing Program (CAN-24) (Last Updated January 11, 2024)
Public Health Agency of Canada
(Webpage) Regulatory Innovation for Health Products: Overview (CAN-41) (Last Updated December 16, 2022)
Health Canada
(Webpage) Research Ethics Board (REB 4: Health Research Ethics Board - Biomedical Panel) (CAN-1) (Current as of July 25, 2024)
University of Alberta
(Webpage) Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB (CAN-35) (Last Updated April 5, 2024)
Health Canada
(Webpage) Resources (CAN-11) (Current as of July 25, 2024)
Network of Networks (N2)
(Webpage) User Guide - Electronic Submissions Gateway (CAN-47) (March 1, 2022)
U.S. Food and Drug Administration
(Document) Accredited Research Ethics Committee in Uganda (UGA-11) (2022)
Uganda National Council for Science and Technology
(Document) Format for Clinical Trial Protocol (UGA-12) (Date Unavailable)
National Drug Authority
(Document) Format for Investigator’s Brochure (UGA-4) (Effective August 20, 2018)
National Drug Authority
(Document) Format of Clinical Trial Report (UGA-6) (Effective August 20, 2018)
National Drug Authority
(Document) Format of Report for Terminated Clinical Trial (UGA-5) (Effective August 20, 2018)
National Drug Authority
(Document) Initial CTA Screening Checklist (UGA-1) (Rev No. 2) (Effective September 14, 2021)
National Drug Authority
(Document) Labelling Investigational Drug Products for Clinical Trial (UGA-7) (Date Unavailable)
National Drug Authority
(Document) Nagoya Protocol on Access and Benefit-sharing (UGA-3) (2011)
Convention on Biological Diversity, United Nations
(International Guidance) Declaration of Helsinki (UGA-27) (October 19, 2013)
World Medical Association
(Not Available Online) NIAID Communication with Makerere University (February 2022) (UGA-31)
(Webpage) Application for Permission to Conduct Research in Uganda (UGA-28) (Current as of February 9, 2024)
Uganda National Council for Science and Technology
(Webpage) Country Profile: Uganda (UGA-21) (Current as of February 9, 2024)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(Webpage) Directorate of Product Safety (UGA-29) (Current as of February 9, 2024)
National Drug Authority
(Webpage) National Drug Authority – Contact Us (UGA-23) (Current as of February 9, 2024)
Ministry of Health
(Webpage) National Drug Authority – Innovation & Research Desk (UGA-10) (Current as of February 9, 2024)
Ministry of Health
(Webpage) National Drug Authority – Service Delivery Timelines (UGA-24) (Current as of July 10, 2024)
National Drug Authority
(Webpage) National Drug Authority: Management Information System (NDAMIS) (UGA-34) (Current as of February 9, 2024)
National Drug Authority
(Webpage) National Research Information Management System (NRIMS) (UGA-33) (Current as of February 9, 2024)
Uganda National Council for Science and Technology
(Webpage) The National Research Clearance Process (UGA-20) (Date Unavailable)
Uganda National Council for Science and Technology
(Webpage) Uganda National Council for Science and Technology – Contact Us (UGA-25) (Current as of February 9, 2024)
Uganda National Council for Science and Technology
(Webpage) Uganda National Council for Science and Technology – Who We Are (UGA-30) (Current as of February 9, 2024)
Uganda National Council for Science and Technology
(Webpage) Uganda National Health Research Organisation – Contact Us (UGA-26) (Current as of February 9, 2024)
Uganda National Health Research Organisation

Forms

(Form) Dossier ID Request Form for Biologic Clinical Trial Dossiers (CAN-20) (Last Updated November 2, 2023)
Health Canada
(Form) Dossier ID Request Form for Pharmaceutical Clinical Trial Dossiers (CAN-21) (Last Updated November 2, 2023)
Health Canada
(Form) Adverse Drug Reactions (ADRs) for Clinical Trials – Expedited Reporting Summary Form (CAN-5) (Date Unavailable)
Health Canada
(Form) Check list for Submitting Requested Development Safety Update Reports (DSUR) in Electronic Format (CAN-38) (Date Unavailable)
Health Canada
(Form) CIOMS Form I (CAN-7) (Date Unavailable)
Council for International Organizations of Medical Sciences
(Form) Clinical Trial Site Information Form (CAN-6) (Ver.21.12.21) (Effective January 2, 2020)
Health Canada
(Form) Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation (CAN-4) (Version 5.03) (Last Updated March 2, 2022)
Health Canada
(Form) Qualified Investigator Undertaking (CAN-37) (March 2, 2022)
Health Canada
(Form) Research Ethics Board Attestation (CAN-8) (March 2, 2022)
Health Products and Food Branch, Health Canada
(Form) Application for Additional Investigators, Change of Investigator or Additional Clinical Trial Sites (UGA-13) (Date Unavailable)
National Drug Authority
(Form) Application Form for Amendment of Conditions of a Clinical Trial (UGA-19) (Effective August 20, 2018)
National Drug Authority
(Form) Application Form for REC Accreditation (UGA-9) (January 2022)
Uganda National Council for Science and Technology
(Form) Application Form for Renewal of Authorization of Clinical Trial (UGA-32) (Effective August 13, 2020)
National Drug Authority
(Form) CIOMS Form I (UGA-8) (Date Unavailable)
Council for International Organizations of Medical Sciences
(Form) CTA Amendments Screening Form (UGA-22) (Effective March 23, 2020)
National Drug Authority
(Form) CTA Screening Renewal Form (UGA-2) (Effective April 17, 2018)
National Drug Authority
(Form) Declaration by Monitor (UGA-17) (Date Unavailable)
National Drug Authority
(Form) Declaration by Principal Investigator (UGA-16) (Date Unavailable)
National Drug Authority
(Form) Declaration by Sponsor and Principal Investigator of Funds of the Clinical Trial (UGA-15) (Date Unavailable)
National Drug Authority
(Form) Letter of Authorization from Holder of Patent of Drug, Licensed Person or Manufacturer of Drug (UGA-18) (Effective October 18, 2019)
National Drug Authority
(Form) Pharmaceutical Data on Dosage Form (UGA-14) (Date Unavailable)
National Drug Authority
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Regulatory authority(ies), relevant office/departments, oversight roles, contact information
Regulatory review and approval processes, renewal, monitoring, appeals, termination
Regulatory fees (e.g., applications, amendments, notifications, import) and payment instructions
Ethics review landscape, ethics committee composition, terms of reference, review procedures, meeting schedule
Ethics committee review and approval processes, renewal, monitoring, termination
Ethics review fees and payment instructions
Authorization of ethics committees, registration, auditing, accreditation
Submission procedures for regulatory and ethics reviews
Essential elements of regulatory and ethics submissions and protocols
Regulatory and ethics review and approval timelines
Pre-trial approvals, agreements, clinical trial registration
Safety reporting definitions, responsibilities, timelines, reporting format, delivery
Interim/annual and final reporting requirements
Sponsor role and responsibilities, contract research organizations, representatives
Site and investigator criteria, foreign sponsor responsibilities, data and safety monitoring boards, multicenter studies
Insurance requirements, compensation (injury, participation), post-trial access
Protocol and regulatory compliance, auditing, monitoring, inspections, study termination/suspension
Electronic data processing systems and records storage/retention
Responsible parties, data protection, obtaining consent
Obtaining and documenting informed consent/reconsent and consent waivers
Essential elements for informed consent form and other related materials
Rights regarding participation, information, privacy, appeal, safety, welfare
Obtaining or waiving consent in emergencies
Definition of vulnerable populations and consent/protection requirements
Definition of minors, consent/assent requirements, conditions for research
Consent requirements and conditions for research on pregnant women, fetuses, and neonates
Consent requirements and conditions for research on prisoners
Consent requirements and conditions for research on persons who are mentally impaired
Description of what constitutes an investigational product and related terms
Investigational product manufacturing and import approvals, licenses, and certificates
Investigator's Brochure and quality documentation
Investigational product labeling, blinding, re-labeling, and package labeling
Investigational product supply, storage, handling, disposal, return, record keeping
Description of what constitutes a specimen and related terms
Specimen import, export, material transfer agreements
Consent for obtaining, storing, and using specimens, including genetic testing