Clinical Research Regulation For Uganda
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language English
Regulatory authority & ethics committee review may be conducted at the same time No
Clinical trial registration required Yes
In-country sponsor presence/representation required Yes
Age of minors Under 18
Specimens export allowed Yes
Regulatory Authority > Regulatory Authority
Last content review/update: July 23, 2020
Requirements
(1) (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
Relevant Sections: Part II (3, 4, 5, and 6) and Schedule 1 (Form 29)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction, 4.2, and 6.0
(3) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.6-1.7
(4) (Legislation) National Drug Policy and Authority Act 1993, (Ch 206) (NDPA Act) (December 3, 1993)
Parliament
Relevant Sections: Part I (3) and Part IV (40)
(5) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.1, 3.2, 3.3, and 3.4
(6) (Legislation) Uganda National Council for Science and Technology Act 1990 – Chapter 209 (UNCST Act) (June 1, 1990)
Parliament
Relevant Sections: 4, 5, and 15
(7) (Legislation) The Uganda National Health Research Organisation Act, 2011 (UNHRO Act) (June 10, 2011)
Parliament
Relevant Sections: Part II
(8) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 6.0 and 7.0
Summary

Overview

As per the NDPA CTReg, the G-CTConduct, and the G-TrialsGCP, the National Drug Authority (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 Additional Resource (A), the Clinical Trials Unit in the NDA’s Directorate of Product Safety is specifically responsible for reviewing and approving the clinical trial applications.

Please note: Uganda is party to the Nagoya Protocol on Access and Benefit-sharing (Additional Resource (B)), 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 Additional Resource (C).

Contact Information

National Drug Authority
Secretariat Office Kampala
Plot 19 Lumumba Avenue
P.O. Box 23096
Kampala, Uganda
Phone: +256 [0]417 788 100 (Reception) / +256 [0]417 788 124 (Directorate of Product Safety) / +256 [0]417 788 129 (Directorate of Inspectorate Services)
Fax: (+256) 41 255758 / 343921
Email: ndaug@nda.or.ug

Uganda National Council for Science and Technology (UNCST)

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 Uganda National Council for Science and Technology (UNCST), or from an institution authorized by the UNCST. According to the NGHRP, the UNCST is a one-stop point for registering and clearing all research to be carried out in Uganda. However, according to Additional Resource (A), only the UNCST approves the clinical trial and issues the research permit.

Established in 1990 by the UNCST Act, the UNCST is a semi-autonomous government agency, operating under the Ministry of Finance, Planning and Economic Development, whose role is to develop and implement strategies for integrating science and technology (S&T) into the national development process, provide advice to the government on S&T policies, and to oversee and coordinate research and development in Uganda.

As per the NGHRP and the UNHRO Act, the UNCST collaborates with the Uganda National Health Research Organisation (UNHRO) to register all health research protocols, and liaises with the Research Secretariat in the Office of the President of Uganda to register and clear 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. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements.)

Contact Information

The Executive Secretary
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 or via the UNCST Contact page.

Additional Resources
(A) NIAID Communication with Makerere University (not available online) (October 4, 2018)
Convention on Biological Diversity, United Nations
(C) (Website) Country Profile: Uganda (Current as of July 17, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(D) (Website) National Drug Authority – Contact Us (Current as of May 4, 2020)
Ministry of Health
(E) (Website) National Drug Authority (Current as of May 4, 2020)
Ministry of Health
Uganda National Council for Science and Technology
(G) (Website) Directorate of Product Assessment & Registration (Current as of May 4, 2020)
National Drug Authority, Ministry of Health
(H) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
Regulatory Authority > Scope of Assessment
Last content review/update: May 05, 2020
Requirements
(1) (Legislation) National Drug Policy and Authority Act 1993, (Ch 206) (NDPA Act) (December 3, 1993)
Parliament
Relevant Sections: 3 and 40
(2) (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
Relevant Sections: Part II (3, 4, 5, 6, 7, 8, and 10) and Schedule 1 (Forms 29 and 36)
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction, 5.0-5.2, 5.4, 5.5, 6.0, 7.1, and Appendix III
(4) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.1, 3.2, 3.3, and 3.4
(5) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.6-1.7
(6) (Circular) No. 033 - Communication on New Format for Clinical Trial Certificates (C-CTCFormat) (December 18, 2019)
National Drug Authority, Ministry of Health
(7) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: Introduction, 6.0, and 7.0
(8) (Legislation) The Uganda National Health Research Organisation Act, 2011 (UNHRO Act) (June 10, 2011)
Parliament
Relevant Sections: Part II
Summary

Overview

In accordance with the NDPA Act, the NDPA CTReg, the G-CTConduct, the NGHRP, 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 Additional Resource (A), the NDA’s review and approval of a clinical trial application is dependent upon the applicant submitting proof of the ethics committee (EC) (research ethics committee (REC) in Uganda) and the Uganda National Council for Science and Technology (UNCST) approvals in the application. Therefore, the NDA and 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.

The online application for UNCST permission to conduct research in Uganda is provided in Additional Resource (B), and the paper application is provided in Additional Resource (C).

Clinical Trial Review Process

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. Applications verified as complete will undergo internal (either expedited or routine), expert, or joint review. Complete applications are given a Clinical Trial Application code, and the NDA issues a Clinical Trial Certificate (CTC) once the application is approved. 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.

According to the C-CTCFormat, the NDA has adopted a new format for the CTC to align with the NDPA Act and the NDPA CTReg.

As per the NDPA CTReg, an application for deviation from a condition of a clinical trial must use Form 36 and must be accompanied by evidence of ethical approval of the amendment to the clinical trial protocol, where applicable. Per the G-CTConduct, the application for amendment of the conditions of a clinical trial can also be found in Appendix III of this guideline, and on the NDA website (Additional Resource (D)). The proposed changes must be listed in a cover letter signed by the applicant, and a clear step-by-step justification for each proposed change(s) must be provided. The possible consequences with regard to the benefit/risk balance for participants already enrolled in the trial must also be summarized in the cover letter.

(See the Clinical Trial Lifecycle topic, Submission Process, Submission Content, and Timeline of Review subtopics for detailed submission requirements and review processes.)

Uganda National Council for Science and Technology

According to the NDPA CTReg, the G-CTConduct, the G-TrialsGCP, and the G-UNCSTreg, 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. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements.)

Uganda National Health Research Organisation

The UNHRO Act authorized the Uganda National Health Research Organisation (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 UNCST.

Additional Resources
(A) (Document) Research Clearance Process (November 2019)
Uganda National Council for Science and Technology
(B) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
National Drug Authority, Ministry of Health
Regulatory Authority > Regulatory Fees
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (4)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.4
(3) (Regulation) The National Drug Policy and Authority (Fees) Regulations, 2014 (S.I. 2014/31) (NDPA FeesReg) (March 28, 2014)
Ministry of Health
Relevant Sections: 2 and Schedule (Part 9)
(4) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 6.0
Summary

Overview

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. The fee must be paid in the form of a check or electronic transfer to the order of the National Drug Authority (NDA) in U.S. dollars (USD) or the equivalent in Ugandan shillings.

In addition, according to the G-UNCSTreg, applicants are responsible for paying fees to the Uganda National Council for Science and Technology (UNCST) for the research permit and for the ethics committee (EC) (research ethics committee (REC) in Uganda) review.

NDA Fees

As set forth in the NDPA FeesReg, the following non-refundable application 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

Additional Resource (A) also states that the NDA fee ranges from $1,000-$4,000 USD, but can be waived in special cases (e.g., for students who are not supported by a university or sponsored by industry).

UNCST Registration Fee

As delineated in the G-UNCSTreg, the 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 Ugandan students registered for study in local institutions, are responsible for paying this fee. Ugandan students are only required to pay a fee of $50 USD.

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 Additional Resource (B), once approval has been granted, a research fee is paid as below:

Amount: $300 USD or $50 USD for Ugandan students (or an equivalent in Ugandan shillings)
Bank: any branch of Standard Chartered Bank
Account title: Uganda National Council for Science and Technology (UNCST)
Account numbers: 8705611811400 (US Dollars) and 0105610632101 (Ugandan shillings)

Additional Resources
(A) (Website) National Drug Authority (Current as of May 4, 2020)
Ministry of Health
(B) (Website) Guidelines and Forms (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Relevant Sections: Review Schedule
Ethics Committee > Ethics Committee
Last content review/update: May 05, 2020
Requirements
(1) (Legislation) Uganda National Council for Science and Technology Act 1990 – Chapter 209 (UNCST Act) (June 1, 1990)
Parliament
Relevant Sections: 4, 5, and 15
(2) (Guidance) Guidelines for Accreditation of Research Ethics Committees (G-RECs) (Version 2.0) (August 2016)
Uganda National Council for Science and Technology
Relevant Sections: 1.0 and 5.0
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.4-3.6, 4.1-4.4, 4.5.1, 4.5.4, 4.6, 4.8, and 4.9
Summary

Overview

Uganda has a centralized registration process for ethics committees (ECs), the majority of which are based at academic institutions or hospitals (ECs are referred to as research ethics committees (RECs) in Uganda). The Uganda National Council for Science and Technology (UNCST), operating under the Ministry of Finance Planning and Economic Development as mandated by the UNCST Act, oversees and coordinates research and development in Uganda as well as EC registration and accreditation.

Per the G-RECs and the NGHRP, an EC is accredited for a three (3)-year period and is not permitted to commence its activities until authorization is received from the UNCST. For multicenter or collaborative trials using the same clinical protocol, the participating institutions may enter into a joint EC review arrangement. See Section 4.2 of the NGHRP for details on EC establishment requirements.

EC 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 in 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 his/her insights about the community from which participants are likely to be drawn

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

Terms of Reference, Review Procedures, and Meeting Schedule

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
  • Conduct initial and periodic reviews of research projects, including site visits, at intervals corresponding to the degree of risk, but not less than once a year
  • 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

See Sections 4.5.1 and 4.9 of the NGHRP for additional 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.

Additional Resources
(A) (Website) Research Ethics Committee Accreditation (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Relevant Sections: UNCST Accredited RECs and Application for REC Accreditation
Ethics Committee > Scope of Review
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3, 4 and 5
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.5-4.6
(3) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.6-1.7
(4) (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
Relevant Sections: Part II (3, 4, 5, 6, 7, 8, and 10) and Schedule 1 (Forms 29 and 36)
(5) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 6.0, 7.0, 12.0, and 13.0
Summary

Overview

In accordance with the NGHRP, the central scope assessed by 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 Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates; Prisoners; and Mentally Impaired for additional information about these populations).

According to the NGHRP, the EC must approve informed consent documentation, and may also require the investigator to administer a comprehension test to ensure participants understand the consent information being provided. Also, an EC may waive some of, or all of, the requirements for the researcher to obtain informed consent in certain situations, including if the research could not practicably be carried out without the waiver. See Section 5.5 of the NGHRP for additional information.

Role in Clinical Trial Approval Process

As per the G-CTConduct, the NGHRP, and the G-TrialsGCP, the National Drug Authority (NDA) approval, the Uganda National Council for Science and Technology (UNCST) registration, and the EC approval of a clinical trial application are mandatory before a study may commence.

Per the NDPA CTReg and Additional Resource (A), proof of the EC and UNCST approval must be submitted in the application to the NDA. However, the G-TrialsGCP states 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. The NGHRP further indicates that the EC also has a continuing responsibility to regularly monitor the approved trial(s) to ensure ethical compliance throughout the study duration.

Per the NDPA CTReg, an application to the NDA for deviation from a condition of a clinical trial must be accompanied by evidence of ethical approval of the amendment to the protocol.

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.

Per the G-UNCSTreg, researchers 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 submission information.

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

Additional Resources
(A) (Document) Research Clearance Process (November 2019)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
(C) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
National Drug Authority, Ministry of Health
Ethics Committee > Ethics Committee Fees
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) Guidelines for Accreditation of Research Ethics Committees (G-RECs) (Version 2.0) (August 2016)
Uganda National Council for Science and Technology
Relevant Sections: 5
(2) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 6.0, 7.0, 12.0, and 13.0
Summary

Overview

According to the G-RECs, ethics committees (ECs) (research ethics committees (RECs) in Uganda) may independently decide what fee to charge for a protocol review. The only instruction provided is that an EC must indicate its fee policy and structure in its self-assessment report submitted to the Uganda National Council for Science and Technology (UNCST) to meet its accreditation requirements. However, per the G-UNCSTreg, research applicants are required to pay the UNCST fees to obtain research clearance (See the Regulatory Authority topic, Regulatory Fees subtopic for UNCST fee requirements).

Additional Resources
No additional resources
Ethics Committee > Authorizing Body
Last content review/update: May 05, 2020
Requirements
(1) (Legislation) Uganda National Council for Science and Technology Act 1990 – Chapter 209 (UNCST Act) (June 1, 1990)
Parliament
Relevant Sections: 4 and 5
(2) (Guidance) Guidelines for Accreditation of Research Ethics Committees (G-RECs) (Version 2.0) (August 2016)
Uganda National Council for Science and Technology
Relevant Sections: 1, 2, 3, 4, 5, 6, and 7
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.2, 3.4, 3.5, 4.1, and 4.2
Summary

Overview

The Uganda National Council for Science and Technology (UNCST) is the central statutory body responsible for the registration, auditing, and accreditation of ethics committees (ECs) (research ethics committees (RECs) in Uganda). As per section 4 of the UNCST Act, the UNCST was created by the Ministry of Finance Planning and Economic Development to provide ethical oversight of clinical research and to safeguard the rights and welfare of human participants involved in clinical studies.

According to the G-RECs, the UNCST’s core responsibilities center on:

  • Improving the efficiency and effectiveness of EC operations
  • Ensuring that ECs provide the highest possible ethical standards and protection to research participants
  • Building public trust and confidence in Uganda’s national ethical review system

Registration, Auditing, and Accreditation

As per the NGHRP, the G-RECs, and Additional Resource (A), the UNCST must register and accredit all ECs. An Accreditation Committee for RECs in Uganda (ACRECU), comprised of five (5) members appointed by the UNCST Executive Secretary, carries out the accreditation process. Members of the ACRECU are appointed on a three (3) year renewable term limit.

UNCST accreditation involves a two-stage process in which the EC conducts a self-assessment and submits a report along with an accreditation application. The ACRECU then reviews the application and inspects the institution. The outcome of the ACRECU reviews are communicated to the EC and the institution within 14 working days from the site inspection date. Accreditation is granted for three (3) years. In order to apply for renewal, an EC must follow the same procedures as in its initial application. The renewal application must be submitted three (3) months prior to the accreditation expiration date. See the G-RECs for additional details on the UNCST accreditation process. A list of UNCST-accredited ECs is also available through Additional Resource (A).

Additional Resources
(A) (Website) Research Ethics Committee Accreditation (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Relevant Sections: UNCST Accredited RECs
(B) (Form) Accreditation of Research Ethics Committees Application Form (Version 2.0) (January 2015)
Uganda National Council for Science and Technology
Clinical Trial Lifecycle > Submission Process
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (3, 4, 5, 6, 7, and 8) and Schedule 1 (Forms 29 and 30)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction, 4.2-4.3, 4.5-4.7, and Appendix I
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 2.2, 3.1, 3.2, 3.3, and 3.4
(4) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 8.0
(5) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.6-1.7
Summary

Overview

According to the NDPA CTReg, the G-CTConduct, the NGHRP, the G-UNCSTreg, and the G-TrialsGCP, local 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 is mandatory before a study may commence.

Per the NDPA CTReg and Additional Resource (A), the NDA’s review and approval of a clinical trial application is dependent upon the applicant submitting proof of the EC and UNCST approvals in the application. Therefore, the NDA and 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.

The online application for UNCST permission to conduct research in Uganda is provided in Additional Resource (B), and the paper application is provided in Additional Resource (C).

According to the NDPA CTReg, an application to the NDA for authorization to conduct a clinical trial shall be made 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 submit a power of attorney verifying his/her appointment as an agent or a letter of authorization (see Form 30 in the NDPA CTReg).

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. The PI should be a Uganda resident and should be licensed by a relevant body in Uganda.

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

Delivery Address for Clinical Trial Application

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

Assembly and Number of Copies

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.

Details for registering with the UNCST are available in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Clinical Trial Application Language Requirements

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 English translation.

Additional Resources
(A) (Document) Research Clearance Process (November 2019)
Uganda National Council for Science and Technology
(B) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
(D) (Website) Guidelines and Forms (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Relevant Sections: Review Schedule
Clinical Trial Lifecycle > Submission Content
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (3, 4, 5, 6, 7, and 8), Schedule 1 (Form 29), and Schedule 2
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction, 4.3, 4.6, Appendices I-II
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.1, 3.2, 3.3, 3.4, and 4.8
(4) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 6.0 and 7.0
(5) (Legislation) The Uganda National Health Research Organisation Act, 2011 (UNHRO Act) (June 10, 2011)
Parliament
Relevant Sections: Part II
(6) (Circular) No. 26 – Incomplete Clinical Trial Application Submissions (C-IncompleteCTA) (December 6, 2018)
National Drug Authority, Ministry of Health
(7) (Circular) No. 009 - Certification of Premises Used to Supply Restricted Drugs within Institutions Conducting Clinical Trials (C-InstitutionCert) (February 27, 2018)
National Drug Authority, Ministry of Health
Summary

Overview

According to the NDPA CTReg, the G-CTConduct, the NGHRP, and the G-UNCSTreg, local 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 is 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 research protocols. However, the registration is conducted centrally at the UNCST.

NDA Requirements

As per Appendices I and II of the G-CTConduct and Additional Resource (A), the following documentation must be submitted to the NDA:

  • Proof of payment
  • Applications for import and/or export of biological materials (if required)
  • Clinical Trial Application Form
  • Trial Protocol
  • Investigators Brochure
  • Participant Information Leaflet and informed consent (IC)
  • Certificate of Good Manufacturing Practice (GMP) manufacture of the trial medicine or other evidence of manufacture quality, safety and consistency
  • Package insert(s) for other trial medicines
  • Certificate of GMP manufacture 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 NDA
  • Signed and completed declarations by all investigators
  • Approval of ECs for the protocol
  • UNCST approval
  • Full, legible copies of key, peer-reviewed published articles supporting the application
  • Sample of the label for the imported products
  • Letter of authorization from the manufacturer/product owner
  • Pharmaceutical data on dosage form
  • Duly signed declaration of the monitor
  • Clinical Trial Agreement between the sponsor and the principal investigator (PI)
  • Other supporting documents

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. 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.

UNCST Requirements

As delineated in the G-UNCSTreg and Additional Resource (B), the PI is also required to register the research proposal for approval with the UNCST. Applicants must complete the UNCST’s Application for Research Approval form (Additional Resource (C)), or submit an online application (Additional Resource (D)). As per Additional Resources (B) and (C), the application should be submitted along with certain documents, including:

  • A copy of research proposal
  • Two (2) copies of data collection instruments
  • An approval letter from the EC
  • A letter of introduction or recommendation from the affiliated institution in Uganda (for foreign investigators only)
  • Three (3) copies of RS6 form completed by PI and co-investigators (Additional Resource (E))
  • Four (4) passport size photos of PI and co-investigators

·       Curriculum vitaes (CVs) for each investigator, dated, and signed and/or initialed on each page

See Additional Resources (B) and (C) for detailed application requirements.

EC Requirements

According to the NGHRP, all ECs must develop detailed standard operating procedures for submission of protocols and other requirements. However, at the minimum, the requirements should include:

  • Research protocol with version and date
  • IC 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 Additional Resource (F), 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 Additional Resource (F).

Additional Resources
(A) (Checklist) Initial CTA Screening Checklist (Effective December 14, 2018)
National Drug Authority, Ministry of Health
(B) (Document) Research Clearance Process (November 2019)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
(D) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
(F) (Form) Format for Clinical Trial Protocol (Date Unavailable)
National Drug Authority, Ministry of Health
(G) (Form) CTA Screening Renewal Form (Effective April 17, 2018)
National Drug Authority, Ministry of Health
National Drug Authority, Ministry of Health
(I) (Form) Declaration by Principal Investigator (Date Unavailable)
National Drug Authority, Ministry of Health
(J) (Form) Declaration by Monitor (Date Unavailable)
National Drug Authority, Ministry of Health
National Drug Authority, Ministry of Health
(L) (Form) Pharmaceutical Data on Dosage Form (Date Unavailable)
National Drug Authority, Ministry of Health
(M) (Document) Format for Investigator’s Brochure (Effective August 20, 2018)
National Drug Authority, Ministry of Health
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (3, 4, 5, 6, 7, and 8), Schedule 1 (Form 29)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction, 4.3, 4.6, 5.0-5.5, and 5.7
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.2-3.5 and 4.9
(4) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 6.0 and 7.0
(5) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.6
(6) (Circular) No. 26 – Incomplete Clinical Trial Application Submissions (C-IncompleteCTA) (December 6, 2018)
National Drug Authority, Ministry of Health
(7) (Circular) No. 009 - Certification of Premises Used to Supply Restricted Drugs within Institutions Conducting Clinical Trials (C-InstitutionCert) (February 27, 2018)
National Drug Authority, Ministry of Health
(8) (Legislation) The Uganda National Health Research Organisation Act, 2011 (UNHRO Act) (June 10, 2011)
Parliament
Relevant Sections: Part II
Summary

Overview

According to the NDPA CTReg, the G-CTConduct, the NGHRP, and the G-UNCSTreg, local 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 is mandatory before a study may commence.

Per the NDPA CTReg and Additional Resource (A), the NDA’s review and approval of a clinical trial application is dependent upon the applicant submitting proof of the EC and UNCST approvals in the application. Therefore, the NDA and 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.

NDA Approval

According to Additional Resource (B), the NDA will acknowledge receipt of a clinical trial application within five (5) working days. The NDA will provide feedback on the initial screening of an application within 10 working days, and reach a decision on the application within 70 working days. When a request is made to an applicant for additional information or clarification, the NDA clock stops until the response is received.

As per the G-CTConduct, NDA reviews for clinical trials 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. When a clinical trial application is submitted to the NDA, the application is first screened for completeness. Per C-IncompleteCTA, the NDA registry will not receive incomplete submissions. All submissions deemed incomplete will be returned with a checklist indicating the missing regulatory requirements. According to the G-CTConduct, the applicant must submit his/her responses in writing or in any other format as advised by the NDA, and in the timeframe determined by the NDA. 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.

The G-CTConduct states that any new information that becomes available regarding the product must be submitted to the NDA as soon as possible. The NDA may request supplementary information or documentation when appropriate, which should be submitted within the stated timeline, usually four (4) weeks. If the requested information is not submitted, the application will be archived within 50 working days. The application will need to be resubmitted for it to be reviewed.

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 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, under which a regulatory decision is given to the applicant within 30 working days, is only 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; or
  • 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

The NDA’s decision shall be communicated to the applicant in writing. Once the application is approved, the NDA issues a Clinical Trial Certificate, which is valid for one (1) year from the date it is awarded.

See the G-CTConduct for detailed NDA review procedures.

EC Approval

An applicant must also submit the clinical trial protocol for review and approval by a UNCST-accredited local 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.

UNCST Approval

As per the G-UNCSTreg and Additional Resource (A), the principal investigator (PI) must register the research proposal for approval with the UNCST. The UNCST provides feedback on the registration status within 10 working days from the submission date. According to the NGHRP, the UNCST registration process is normally completed within 14 working days.

As per the NGHRP and the UNHRO Act, the UNCST also collaborates with the UNHRO to register all health research protocols, and liaises with the Research Secretariat in the Office of the President of Uganda to register and clear all research intended to be carried out in the country. The collaborative UNCST/UNHRO registration process is conducted centrally at UNCST.

Additional Resources
(A) (Document) Research Clearance Process (November 2019)
Uganda National Council for Science and Technology
(B) (Website) National Drug Authority – Service Delivery Timelines (Current as of May 4, 2020)
National Drug Authority, Ministry of Health
(C) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (3, 4, 5, 6, 7, 8, and 9), Schedule 1 (Form 29)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction, 4.3, 4.6, 4.8, 10.0-10.1, and Appendix I
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.1, 3.2, 3.3, 3.4, 3.6.2, 4.8, and 6.0
(4) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 6.0 and 7.0
(5) (Legislation) The Uganda National Health Research Organisation Act, 2011 (UNHRO Act) (June 10, 2011)
Parliament
Relevant Sections: Part II
(6) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.6, 3.2, 4.5, 6.10, and 10.3.1
Summary

Overview

According to the NDPA CTReg, the G-CTConduct, the NGHRP, and the G-UNCSTreg, local 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 is 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.

Per the NDPA CTReg and Additional Resource (A), the NDA’s review and approval of a clinical trial application is dependent upon the applicant submitting proof of the EC and UNCST approvals in the application. Therefore, the NDA and 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.

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. The trial must be conducted in compliance with the NDPA CTReg, the G-CTConduct, the G-TrialsGCP, and the NGHRP. As per the G-TrialsGCP, all investigators should possess appropriate qualifications, training, and experience.

According to the NGHRP, a care package for research participants should be stated 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. The duration and sustainability of care and treatment for the research participant after the study should be negotiated before initiation of the study. Also, the sponsor and researcher shall put in place a mechanism for compensating research related injury at the commencement of a study. For more information, see Section 6 of the NGHRP.

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). 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.

In addition, according to the G-TrialsGCP, the sponsor should ensure that the protocol or other written agreement specifies that the investigator(s)/institution(s) will permit trial-related monitoring, audits, EC review, and regulatory inspection(s), providing direct access to source data/documents. A signed agreement between involved parties (such as the PI/institution and sponsor; the PI/institution and CRO; and the sponsor and CRO), is also considered an essential document before a clinical trial can commence.

EC Confirmation of Review and Approval

The NDPA CTReg, the G-TrialsGCP, and the G-CTConduct mandate that the sponsor or the PI receive written confirmation of EC review and approval of the protocol and submit this approval to the NDA prior to the trial’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Clinical Trials 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.

Data and Safety Monitoring Board

As set forth in the NGHRP and the NDPA CTReg, the sponsor is also required to establish a Data and Safety Monitoring Board (DSMB) prior to a trial’s commencement, and submit its composition to the EC and the UNCST. 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 and the NDPA CTReg.

Additional Resources
(A) (Document) Research Clearance Process (November 2019)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
(C) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
(D) (Form) Declaration by Principal Investigator (Date Unavailable)
National Drug Authority, Ministry of Health
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part I (2), Part III (18 and 19), Part IV (21 and 22), and Schedule 1 (Form 29)
(2) (Regulation) The National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014 (S.I. 2014/37) (NDPA PVReg) (March 28, 2014)
Ministry of Health
Relevant Sections: 2, 3, 6, and Schedule (Format of Report on Suspected Adverse Drug Reactions for Human Drugs)
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 2.0 and 9.1
(4) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.6.2, 7.1, 7.2, 9.1, 9.2, 9.3, and 9.4
(5) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.1, 3.4, 3.13, 4.18-4.19, and 4.8
Summary

Overview

In accordance with the NDPA CTReg, the NDPA PVReg, 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)

Reporting Requirements for AEs/ADRs

Per Additional Resource (A), the National Drug Authority (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) (Additional Resource (B)).

Investigator Responsibilities

As per the NDPA CTReg and the G-TrialsGCP, all SAEs/SADRs must also be reported by the principal investigator (PI) 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 NDA, and the 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 reportable 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 AEs/ADRs related to trials 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.

Data and Safety Monitoring Board

As set forth in the NGHRP and the NDPA CTReg, the sponsor is required to establish an independent group of experts known as a Data and Safety Monitoring Board (DSMB) to review safety data during a clinical trial. A DSMB’s role is to ensure that the trial is conducted in accordance with the protocol provisions and to monitor AEs/ADRs and safety data. A DSMB must be established prior to a trial’s commencement, and its composition must be submitted to the EC and the UNCST. 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 and the NDPA CTReg.

The G-TrialsGCP further indicates that a DSMB (also referred to as an Independent Data-Monitoring Committee (IDMC)) 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.

Additional Resources
(A) NIAID Communication with Makerere University (not available online) (May 2, 2020)
(B) (Form) CIOMS Form I (Date Unavailable)
Council for International Organizations of Medical Sciences
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (12) and Schedule 2 (Format for the Clinical Trial Report)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 9.4-9.5
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 7.2
(4) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.7.6, 3.15, and 5.2
(5) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 14.1 and 14.4
Summary

Overview

In accordance with the NDPA CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP, the principal investigator (PI) and the sponsor share responsibility for submitting progress reports on the status of a clinical trial, and for submitting a comprehensive final report. Schedule 2 of the NDPA CTReg contains the form for submitting a clinical trial report.

Interim/Progress Reports

As per the G-TrialsGCP, the PI is obliged to submit progress reports as required by the sponsor, the 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; and
  • If the planned time schedule is still appropriate.

The format and frequency of reporting shall be 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, researchers 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.

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 researcher’s obligation to submit final reports of his/her research projects to the UNCST. Researchers 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. Researchers who are foreign nationals are required to submit a study completion report before returning to their countries.

Additional Resources
(A) (Document) Format of Clinical Trial Report (Effective August 20, 2018)
National Drug Authority, Ministry of Health
(B) (Document) Format of Report for Terminated Clinical Trial (Effective August 20, 2018)
National Drug Authority, Ministry of Health
Sponsorship > Definition of Sponsor
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part I (2), Part IV (4), Schedule 1 (Form 30)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 2.0 and 4.3
(3) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 3) (G-GMPMedicinal) (Effective March 31, 2020)
National Drug Authority, Ministry of Health
(4) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 2) (G-GMPMedicinalAnnexes) (Effective March 31, 2020)
National Drug Authority Ministry of Health
Relevant Sections: Annex 13
(5) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.1
(6) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 7.2
Summary

Overview

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. Further, the G-GMPMedicinalAnnexes states that sponsors are required to assume ultimate responsibility for all aspects of the clinical trial including the quality of investigational medicinal products. The increased complexity in manufacturing operations requires a highly effective quality system.

The NDPA CTReg also specifies that in order for the sponsor to submit a clinical trial application, he/she 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

Per NDPA CTReg, in the case of foreign sponsors, a local company in Uganda must submit a letter of authorization from the licensed person or manufacturer of the drug to be the agent in the clinical trial and is responsible for all matters pertaining to the NDA clinical trial certificate (See Additional Resource (A)). The G-CTConduct further 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 PI who is the representative of the in-country sponsor. The PI should be a resident of Uganda and should be licensed by a relevant body in Uganda. The qualifications of the PI should be in line with the proposed study with careful consideration of the population and the product.

Additional Resources
National Drug Authority, Ministry of Health
Sponsorship > Trial Authorization
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (4) and Schedule 1 (Form 30)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 2.0, 4.3, 4.6, and Appendix I
(3) (Circular) No. 033 - Communication on New Format for Clinical Trial Certificates (C-CTCFormat) (December 18, 2019)
National Drug Authority, Ministry of Health
(4) (Legislation) National Drug Policy and Authority Act 1993, (Ch 206) (NDPA Act) (December 3, 1993)
Parliament
Summary

Overview

In accordance with the NDPA CTReg and the G-CTConduct, the sponsor or the principal investigator (PI) is responsible for submitting a clinical trial application to the National Drug Authority (NDA) to obtain approval to conduct a study, and for registering the study with the Uganda National Council for Science and Technology (UNCST). 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

Per the NDPA CTReg, in those cases where a local agent submits the clinical trial application, the agent must submit a power of attorney verifying his/her appointment as an agent or a letter of authorization (see Form 30 in the NDPA CTReg or Additional Resource (A)). The agent is responsible for all matters pertaining to the NDA Clinical Trial Certificate (CTC). The G-CTConduct further indicates that based on the Clinical Trial Agreement between the sponsor and the PI, the NDA will liaise with the PI who is the representative of the in-country sponsor. The PI should be a resident of Uganda and should be licensed by a relevant body in Uganda. The qualifications of the PI should be in line with the proposed study with careful consideration of the population and the product.

According to the C-CTCFormat, the NDA has adopted a new format for the CTC to align with the NDPA Act and the NDPA CTReg.

To complete the clinical trial application package, the applicant must use the NDA’s clinical trial application form (see Appendix I of the G-CTConduct).

In addition to the completed NDA application, the applicant must also provide the clinical protocol, the participant information leaflet and informed consent form, a signed declaration by the investigators, a certificate of good manufacturing practice for the manufacture of the trial medicine, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

The online application for UNCST permission to conduct research in Uganda is provided in Additional Resource (C), and the paper application is provided in Additional Resource (D).

Additional Resources
National Drug Authority, Ministry of Health
(B) (Form) Declaration by Principal Investigator (Date Unavailable)
National Drug Authority, Ministry of Health
(C) (Website) Application for Permission to Conduct Research in Uganda (Current as of May 4, 2020)
Uganda National Council for Science and Technology
Uganda National Council for Science and Technology
Sponsorship > Insurance
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part III (15) and Schedule 1 (Form 29)
(2) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 3.12 and 4.11
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.6 and Appendix I
(4) (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, Ministry of Health
Relevant Sections: 3.0 and 7.0
(5) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 6.5
Summary

Overview

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.

In accordance with the NGHRP, the sponsor and researcher shall put in place a mechanism for compensating research-related injury at the commencement of a study. The mechanism, which may include, inter alia, insurance, and medical care, should be acceptable to the ethics committee (EC) (research ethics committee (REC) in Uganda).

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 2.2.2, 6.1, 6.3, 6.4, 6.5, 6.6, and 7.2
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: Appendix I
(3) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.12
Summary

Overview

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 researcher 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.

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.”

In the event of any trial-related injuries, the sponsor is required to ensure that the research participants are not asked to waive their legal rights to seek compensation.

The sponsor and researcher 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 ethics committee (EC) (research ethics committee (REC) in Uganda). The EC, research participant, and/or researcher may initiate the compensation process. The EC, sponsor, and researcher shall agree on an appropriate mechanism for arbitration.

In the clinical trial application made to the National Drug Authority (NDA), the applicant must explain how he/she will compensate the participant(s) for their time and other inconveniences, in accordance with the G-CTConduct.

In addition, per the NGHRP, participants must be 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. 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 also 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.

(See the Informed Consent topic, Compensation Disclosure subtopic for additional information.)

Additional Resources
No additional resources
Sponsorship > Quality, Data & Records Management
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 2) (G-GMPMedicinalAnnexes) (Effective March 31, 2020)
National Drug Authority Ministry of Health
Relevant Sections: Annex 13
(2) (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
Relevant Sections: Part II (12) and Part III (15)
(3) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.7.5, 3.9, 4.3, 4.8, 4.20, 4.21, and 4.25
(4) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 3) (G-GMPMedicinal) (Effective March 31, 2020)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction and Chapter 4
(5) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 5.6 and 9.5
(6) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 5 and 11.2
Summary

Overview

As stated in the G-GMPMedicinalAnnexes, the sponsor is responsible for the initiation, management, and/or financing of a clinical trial in Uganda. The sponsor should also have access to the quality system standard operating procedures (SOPs) that the manufacturer or importer has designed, established, and verified.

The NDPA CTReg also 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 Clinical Trial Lifecycle topic, Safety Reporting subtopic contains information regarding reporting.

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 Section 4.3 of the G-TrialsGCP.

As per the G-GMPMedicinalAnnexes, the sponsor is responsible for sending a written order to the manufacturer to process, package, and/or ship investigational products (IPs) for a clinical trial. This order should be formally authorized and refer to the Product Specification File and the relevant clinical trial protocol.

In addition, during the shipping process, the sponsor maintains control of the IP until certification by the manufacturer’s Authorized Person and the fulfillment of relevant requirements on:

  • Batch records
  • Production conditions
  • Validation status of facilities, processes, and methods
  • Examination of finished packs
  • Results of any analyses or tests performed after importation, where relevant
  • Source and verification of conditions of storage and shipment
  • Audit reports concerning the quality system of the manufacturer
  • Documents certifying that the manufacturer is authorized to manufacture IPs or comparators
  • Regulatory requirements

The sponsor must ensure that the IP is consistent with the details in the clinical application and NDA’s authorization. This can be achieved through a change control process for the Product Specification File and defined in a Technical Agreement between the sponsor and the Authorized Person. The sponsor should record and retain all relevant documentation. Per the G-GMPMedicinal, the manufacturer should retain IP documentation for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the IP was used.

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 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.

Record Management

As per the NDPA CTReg, the G-CTConduct, and the G-TrialsGCP, the sponsor and the investigator(s) are responsible for ensuring the safety of all trial-related documentation. The sponsor should retain documents for a minimum period of 20 years and inform the National Drug Authority (NDA) in writing prior to destroying any documents.

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. Researchers must have in place mechanisms for maintaining 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 researchers must have unrestricted access rights to data sets collected through a collaborative research project. Lastly, researchers 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.

Audit Requirements

According to the NGHRP, the sponsor or PI must conduct audits or inspections of the trial as prescribed in the study protocol. The NDA may conduct an inspection or audit of the clinical trial to ensure the protocol and all applicable regulatory requirements are followed.

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 ethics committee (EC) (research ethics committees (RECs) in Uganda) and the NDA. The audit report should be submitted to the NDA if evidence of good clinical practice (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 Additional Resource (A). The notification must give reasons for the termination, indicate the disposal process for the unused IP, 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.

Multicenter Studies

The G-TrialsGCP indicates that where necessary, site-investigators for multicenter trials should develop site-specific SOPs or a site implementation plan to guide the respective sites on implementation of the protocol at that site. The sponsor should ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and which received EC and NDA approvals
  • 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
Additional Resources
(A) (Document) Format of Report for Terminated Clinical Trial (Effective August 20, 2018)
National Drug Authority, Ministry of Health
Sponsorship > Site/Investigator Selection
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part II (7) and (10)
(2) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.6, 3.0, 4.9, 6.10, 10.3
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.3 and Appendix I
(4) (Circular) No. 009 - Certification of Premises Used to Supply Restricted Drugs within Institutions Conducting Clinical Trials (C-InstitutionCert) (February 27, 2018)
National Drug Authority, Ministry of Health
(5) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 8.0
(6) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 3.6.2
Summary

Overview

Based on the NDPA CTReg and the G-TrialsGCP, the sponsor oversees the selection of the investigator(s) and the institution(s) for the clinical trial. According to the G-CTConduct and the G-TrialsGCP, the principal investigator (PI) should be a resident of 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. The investigator should also be given sufficient time to review the protocol and the information provided.

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 National Drug Authority (NDA), and the protocol agreed upon by the sponsor and given approval by the relevant ethics committee (EC) (research ethics committee (REC) in Uganda)
  • 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

As delineated in the NDPA CTReg and the G-CTConduct, before the trial begins, the sponsor must sign a clinical trial agreement with the PI. 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. In addition, according to the G-TrialsGCP, a signed agreement between involved parties (such as the PI/institution and sponsor; the PI/institution and CRO; and the sponsor and CRO) is also considered an essential document before a clinical trial can commence. 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.

According to the NDPA CTReg, an application for additional investigators, additional clinical trial sites, or for change of the investigators must be made using Additional Resource (A) and must be accompanied by evidence of ethical approval of the amendment to the clinical trial protocol, where applicable, and the prescribed fees. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for additional information on clinical trial application requirements.)

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.

Foreign Investigator Responsibilities

In accordance with the G-UNCSTreg, all researchers who are foreign nationals are required to identify and become affiliated with a local organization appropriate for their type of research in Uganda. Researchers arrange the affiliation themselves with the local organization. The researcher should obtain a letter of recommendation from the local organization, which they submit to the Uganda National Council for Science and Technology (UNCST). Per NDPA CTReg, the local company in Uganda must submit a letter of authorization from the licensed person or manufacturer of the drug to be the agent in the clinical trial and is responsible for all matters pertaining to the NDA clinical trial certificate (See Additional Resource (C)).

Data and Safety Monitoring Board

In addition, according to the NGHRP and the NDPA CTReg, the sponsor is responsible for establishing a Data and Safety Monitoring Board (DSMB) prior to the trial’s commencement. 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 and the UNCST. (See the Clinical Trial Lifecycle topic, Trial Initiation subtopic for additional information.)

No additional information is available regarding the sponsor’s role in selecting the EC or overseeing multicenter trials.

Additional Resources
National Drug Authority, Ministry of Health
(B) (Form) Declaration by Principal Investigator (Date Unavailable)
National Drug Authority, Ministry of Health
National Drug Authority, Ministry of Health
Informed Consent > Documentation Requirements
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 4.5.1, 4.7, 4.8, 5.1, 5.2, and 5.4
(2) (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
Relevant Sections: Part II (4) and Part III (14)
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.6 and 4.7
(4) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 3.7 and 4.25
Summary

Overview

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.

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 ethics committee (EC) (research ethics committee (REC) in Uganda) and provided to the National Drug Authority (NDA) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

The investigator(s) should provide research study information to the participant and/or his/her legal representative(s) or guardian(s). When drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education. The ICF content should be brief and clearly presented without coercion or unduly influencing a potential participant to enroll in the clinical trial.

Participant information may be presented in written or oral form, and should be communicated in a language and form understandable to the participant and/or his/her legal representative(s) or guardian(s). The participant and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must personally sign the ICF. In situations in which the research participant prefers not to execute a written ICF, the investigator must obtain oral informed consent and document that it has been obtained. The participant or his/her legal representative(s) or guardian(s) may sign the form using his/her thumbprint to indicate that he/she has read and understood and agrees to participate in the study.

Re-Consent

According to the NGHRP and the G-TrialsGCP, any change to the research study that may impact the participant’s willingness to continue requires a new ICF to be approved by the EC and submitted to the NDA before such changes are implemented. The participant and/or his/her legal representative(s) or guardian(s) will also be required to sign the revised ICF.

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.

Documentation Copies

The NGHRP states that the participant and the investigator(s) should sign the ICF. If the participant is incapable of giving an informed consent, his/her legal representative(s) or guardian(s) should sign and date the ICF. In cases where oral consent is allowed, the investigator must document that the consent was obtained.

The investigator(s) should retain a copy of the signed ICF, and one (1) copy should be offered to the participant for his/her record.

Additional Resources
No additional resources
Informed Consent > Required Elements
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 4.5.1, 4.8, 5.1, 5.2, 5.3, and 5.4
(2) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 3.7
(3) (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
Relevant Sections: Part III (14)
Summary

Overview

As delineated in the NGHRP and the G-TrialsGCP, prior to beginning a research study, the investigator(s) is required to obtain ethics committee (EC) (research ethics committee (REC) in Uganda) approval for the written informed consent form (ICF), the patient information leaflet, and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

Information should be presented in easily understandable language that is as non-technical as practical, and may be presented in written and/or oral form. Adequate time should be given to the participant and/or his/her legal representative(s) or guardian(s) to inquire about the details of the study and have all questions answered to his/her satisfaction.

No Coercion

None of the oral and written information concerning the study, including the written ICF, should contain any coercive language. In addition, it should not release or appear to release the investigator(s), the institution, the sponsor, or his/her representatives from his/her liabilities for any negligence.

ICF Required Elements

Based on the NGHRP, the NDPA CTReg, and the G-TrialsGCP, the ICF should include the following statements or descriptions, as applicable (Note: The regulatory sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • 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 and/or his/her legal representative(s) or guardian(s) 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 EC
  • 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 his/her 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

(See the Informed Consent topic, Compensation Disclosure and Vulnerable Populations subtopic as well as the Specimens topic, Consent for Specimen subtopic for further information.)

Additional Resources
No additional resources
Informed Consent > Compensation Disclosure
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 5.3, 6.5, and 6.6
(2) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 3.7 and 4.12
Summary

Overview

In accordance with the NGHRP and the G-TrialsGCP, the informed consent form (ICF) should contain a statement describing the compensation or benefits a participant may receive for participating in a clinical trial.

Compensation for Participation in Research

As stated in the NGHRP, the ICF should contain a statement with a description of the nature, form, and extent of compensation for study participation, including any reimbursement for transportation, time, and meals. Research participants shall be fairly compensated for inconveniences, time spent, and expenses incurred. Research participants may also receive free medical services.

However, the compensation or medical services must not be so excessive that it may unfairly influence participants or cause them to overlook important facts or risks. The G-TrialsGCP further specifies that the sponsor must ensure that participants are reimbursed for all reasonable costs incurred by their participation in the trial.

Compensation for Injury

As per the NGHRP, the ICF should include a statement advising the participant about compensation and medical treatment(s) available in the event of any trial-related physical, social, economic, or psychological injury; what they consist of; and where further information may be obtained. In Uganda, injuries are classified according to their relationship to the trial as follows:

  • Definitely – An injury directly caused by trial participation
  • Probably – When the injury is most likely explained by trial participation, but no definite proof of causality is evident
  • Possibly – When an explanation for the injury is equally due to trial participation or other cause
  • Unlikely – When the injury is more likely explained by a cause other than trial participation
  • Not related – When the injury is clearly due to a cause other than trial participation

(See the Sponsorship topic, Compensation subtopic for additional details on compensation requirements.)

Additional Resources
No additional resources
Informed Consent > Participant Rights
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 1.1, 1.3, 1.4, 2.2, 2.3, 5.1, 5.2, 5.3, and 5.4
(2) (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
Relevant Sections: Part II (4) and Part III (14)
(3) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 3.7
Summary

Overview

Uganda’s ethical standards promote respect for all human beings and safeguard the rights of research participants, including the right of their autonomy, culture, beliefs, and values. In addition, participants also have the right to receive the nationally available standard of health care, and the right to report any trial-related abuses to the investigator(s), the ethics committee (EC) (research ethics committee (REC) in Uganda), the National Drug Authority (NDA), and the Uganda National Council for Science and Technology (UNCST). 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 Informed Consent topic, and the subtopics of Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired 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 in the instance of a participant from a vulnerable population, his/her legal representative(s) or guardian(s)—should be informed that participation is voluntary, that he/she 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

A potential research participant and/or his/her legal representative(s) or guardian(s) 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. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality

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

The research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the investigator(s) and the EC to address trial-related inquiries in the event of any injury and/or to appeal against a violation of his/her rights. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Safety and Welfare

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

Additional Resources
No additional resources
Informed Consent > Special Circumstances/Emergencies
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 5.3, 5.5, and 8.1
(2) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 3.7
Summary

Overview

The NGHRP and the G-TrialsGCP make provisions to protect the rights of a research participant during the informed consent process when special circumstances complicate the procedure.

Medical Emergencies

The NGHRP allows the ethics committee (EC) (research ethics committee (REC) in Uganda) to waive some or all of the informed consent requirements in instances of medical emergencies where consent cannot be reasonably obtained from the individual or his/her representative.

The G-TrialsGCP further states that in emergency situations, when prior consent of the participant not possible, the consent of his/her legal representative(s), if present, should be requested. When prior consent of the participant is not possible and his/her legal representative(s) is not available, enrollment of the participant should require measures 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 his/her legal representative(s) should be informed about the trial as soon as possible, and consent to continue and other consent as appropriate should be requested.

Waiver of Consent

An EC may waive some or all of the requirements for the investigator to obtain an informed consent or a signed/thumb-printed informed consent form (ICF) for some or all of the participants of a study if the EC determines that the research being conducted meets one of the following conditions:

  • It involves only minimal risk
  • The study could not be carried out without the waiver or alteration
  • In cases where deception needs to be applied to achieve the objectives of the study
  • The only record linking the participant and the study would be the ICF, and the principal risk to the participant would be potential harm resulting from a breach of confidentiality
  • When it is necessitated in emergency situations where no proxy consent can be taken

If the EC grants a waiver of written informed consent, each participant should be asked whether he/she wishes to have documentation that links him/her with the study, and the participant’s wishes must be followed. In situations in which the participant prefers not to complete a written ICF, the investigator must obtain oral informed consent and document that it has been obtained.

Additional Resources
No additional resources
Informed Consent > Vulnerable Populations
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 2.3, 4.7, 8.1 and 8.2
(2) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.1 and 2.3
Summary

Overview

In all Ugandan clinical trials, research participants from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. According to the NGHRP, 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 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, and pregnant women.

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.

Per the NGHRP, the ethics committee (EC) (research ethics committee (REC) in Uganda) must carefully consider and approve the mode of consent for participants from vulnerable populations. ECs must ensure that:

  • Selection of the particular community is justified by the research goals
  • Research is relevant to the needs and priorities of the community in which it is to be conducted
  • Research is beneficial to that community
  • The community can access products of the research
  • Where appropriate, feedback of results relevant to the community is provided
  • Participants are fully aware that they are participating in the research, and provide informed consent. It is essential that special attention be paid to the content and language of the informed consent form, the procedures for obtaining informed consent, and any precautions such as monitoring the process and testing comprehension.

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 Informed Consent topic, and the subtopics of Children/Minors; and Pregnant Women, Fetuses & Neonates subtopics for additional information about these vulnerable populations.

Additional Resources
No additional resources
Informed Consent > Children/Minors
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 5.6, 5.8, and Glossary
Summary

Overview

The NGHRP defines a child as a person below the age of 18. 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 ethics committee (EC) (research ethics committee (REC) in Uganda) approves the research study as acceptable to the legal representative(s) and/or guardians based on evidence from the community
  • The protocol provides clear justification for targeting mature and emancipated minors as participants, and for not involving legal representative(s) and/or guardian(s) 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 his/her legal representative's and/or guardian’s consent is obtained.

Additional Resources
No additional resources
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 5.7
Summary

Overview

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 the purpose of the study is primarily to meet the mother's health needs, the father's identity or whereabouts are unknown, the father is not reasonably available, or the pregnancy resulted from rape or incest.

(See the Informed Consent topic, Required Elements subtopic for general informed consent form requirements.)

Additional Resources
No additional resources
Informed Consent > Prisoners
Last content review/update: May 05, 2020
Requirements
No applicable regulatory requirements
Summary

No relevant provisions

Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: May 05, 2020
Requirements
No applicable regulatory requirements
Summary

No relevant provisions

Additional Resources
No additional resources
Investigational Products > Definition of Investigational Product
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: Glossary
(2) (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
Relevant Sections: Part I (2)
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 2.0
(4) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 3) (G-GMPMedicinal) (Effective March 31, 2020)
National Drug Authority, Ministry of Health
(5) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 2) (G-GMPMedicinalAnnexes) (Effective March 31, 2020)
National Drug Authority Ministry of Health
Relevant Sections: Annex 13
(6) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 1.1
Summary

Overview

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.

This includes:

  • A registered product 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
Additional Resources
No additional resources
Investigational Products > Manufacturing & Import
Last content review/update: July 23, 2020
Requirements
(1) (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
Relevant Sections: Part II (9) and Schedule 1 (Form 30)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 10.0-10.2
(3) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 3) (G-GMPMedicinal) (Effective March 31, 2020)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction, and Chapters 1 and 4
(4) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.15
(5) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part II – Basic Requirements for Active Pharmaceutical Ingredients (G-GMPMedicinalAPIs) (Effective January 30, 2020)
National Drug Authority, Ministry of Health
Relevant Sections: Section 20
(6) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 2) (G-GMPMedicinalAnnexes) (Effective March 31, 2020)
National Drug Authority Ministry of Health
Relevant Sections: Annex 13
Summary

Overview

According to the NDPA CTReg, the G-CTConduct, the G-GMPMedicinal, 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. Per the G-GMPMedicinal, the NDA issues a manufacturing authorization, which requires the holder to ensure he/she manufactures IPs in compliance with the requirements of the clinical trial authorization.

The NDA is also 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. (See Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics, and Regulatory Authority topic, Regulatory Fees subtopic for detailed application requirements).

The G-GMPMedicinalAPIs indicates that once drug development reaches the stage where the active pharmaceutical ingredient (API) is produced for use in IPs intended for clinical trials, manufacturers should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API. The production of APIs for use in clinical trials should be documented in laboratory notebooks, batch records, or by other appropriate means.

As per the G-GMPMedicinalAnnexes, the sponsor is responsible for sending a written order to the manufacturer to process, package, and/or ship IPs for a clinical trial. This order should be formally authorized and refer to the Product Specification File and the relevant clinical trial protocol. The Product Specification File is a reference file that contains all of the information necessary to develop written instructions on processing, packaging, quality control testing, batch release, and shipping of an IP.

The sponsor must ensure that the IP is consistent with the details in the clinical application and NDA’s authorization. This can be achieved through a change control process for the Product Specification File and defined in a Technical Agreement between the sponsor and the Authorized Person. The sponsor should record and retain all relevant documentation.

In addition, the G-GMPMedicinal and the G-GMPMedicinalAnnexes require the manufacturer to create and/or maintain the following documentation:

  • A site master file describing good manufacturing practice (GMP)-related activities
  • A written order from the sponsor that requests the processing and/or packaging of a certain number of units and/or their shipping; it should be formally authorized and refer to the Product Specification File and the relevant clinical trial protocol
  • Product Specification File (See the documentation requirements in Annex 13 of the G-GMPMedicinalAnnexes for more information on the contents of this document)
  • Specifications to serve as a basis for quality evaluation
  • Manufacturing formula, processing, packaging, and testing instructions
  • Standard operating procedures
  • Protocols for performing and recording operations
  • Technical agreements
  • Records to demonstrate compliance with instructions
  • A Certificate of Analysis to provide a summary of testing results on product samples with the evaluation for compliance to a stated specification
  • Reports that document the conduct of investigations and the results

Please note: Uganda is party to the Nagoya Protocol on Access and Benefit-sharing (Additional Resource (A)), 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 Additional Resource (B).

Additional Resources
Convention on Biological Diversity, United Nations
(B) (Website) Country Profile: Uganda (Current as of July 17, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
Investigational Products > IMP/IND Quality Requirements
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part I (2), Part II (4), Part III (15 and 16), Schedule 1 (Forms 29, 30, 34, 35, and 38), and Schedule 2 (Format for Investigator’s Brochure)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 2.0, 4.6.1, 10.2, and 10.5-10.5.1
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 7.2
(4) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.15 and 7.0-7.3
(5) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 2) (G-GMPMedicinalAnnexes) (Effective March 31, 2020)
National Drug Authority Ministry of Health
Relevant Sections: Annex 13
(6) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part II – Basic Requirements for Active Pharmaceutical Ingredients (G-GMPMedicinalAPIs) (Effective January 30, 2020)
National Drug Authority, Ministry of Health
Relevant Sections: Section 20
(7) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 3) (G-GMPMedicinal) (Effective March 31, 2020)
National Drug Authority, Ministry of Health
Relevant Sections: Introduction and Chapter 4
Summary

Overview

In accordance with the NDPA CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP, the sponsor is responsible for preparing the Investigator’s Brochure (IB), which is a compilation of the clinical and non-clinical data on the investigational product(s) (IPs). The IB must contain all of the relevant information on the IPs including chemical, pharmaceutical, toxicological, pharmacokinetic, and pharmacodynamic data obtained from studies in animals as well as in humans, and the results of earlier clinical trials, if applicable.

Per the G-GMPMedicinalAnnexes, the sponsor has the ultimate responsibility for all aspects of the clinical trial including the quality of IPs and associated manufacturing operations. However, according to the NDPA CTReg, the principal investigator (PI) is responsible and accountable for the IP.

The G-GMPMedicinalAPIs states that when manufacturing active pharmaceutical ingredients (APIs), 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 intended for clinical trials, manufacturers should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API.

IB Content Requirements

The G-TrialsGCP 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 guidelines, and Additional Resource (B) or Schedule 2 of the NDPA CTReg for the format of the IB.

Certificate of Analysis and GMP Certificate

Per the G-GMPMedicinal, the manufacturer is required to provide a certificate of analysis that contains a summary of testing results on samples of products or materials together with the evaluation for compliance to a specification. In addition, the National Drug Authority (NDA) conducts periodic good manufacturing practice (GMP) inspections of all manufacturers of medicinal products within and outside Uganda. The NDA will issue a GMP compliance certificate to manufacturers that are GMP compliant. Further, as specified in the G-GMPMedicinalAnnexes, the manufacturer must establish a quality system that is described in written procedures and available to the sponsor. This system should take into account GMP principles and guidelines that apply to IPs.

According to the G-CTConduct and the G-TrialsGCP, the sponsor must ensure that the IP(s) is manufactured in accordance with GMP and is coded and labeled in a manner that protects the blinding, if applicable. The G-CTConduct further indicates that evidence of manufacture under GMP standards must be submitted with the clinical trial application to the NDA.

As per the G-CTConduct, 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.

(See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Additional Resources
(A) (Document) Format for Investigator’s Brochure (Effective August 20, 2018)
National Drug Authority, Ministry of Health
(B) (Form) Pharmaceutical Data on Dosage Form (Date Unavailable)
National Drug Authority, Ministry of Health
Investigational Products > Labeling & Packaging
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 3) (G-GMPMedicinal) (Effective March 31, 2020)
National Drug Authority, Ministry of Health
Relevant Sections: Chapter 1
(2) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 2) (G-GMPMedicinalAnnexes) (Effective March 31, 2020)
National Drug Authority Ministry of Health
Relevant Sections: Annex 13
(3) (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
Relevant Sections: Part III (17) and Schedule 1 (Form 38)
(4) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.6.1, 10.3, and Appendix I
(5) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 7.2
(6) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.15
Summary

Overview

Labeling for investigational products (IPs) (known as investigational medicinal products (IMPs) in Uganda)) must comply with the requirements set forth in the G-GMPMedicinal, the G-GMPMedicinalAnnexes, the NDPA CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP. As specified in the G-GMPMedicinalAnnexes, for an IP to be used in a clinical trial, it must be properly labeled in the official language of the country where the trial is being conducted.

As per the NGHRP, the G-TrialsGCP, and the G-GMPMedicinalAnnexes, the sponsor is responsible for ensuring the proper packaging and labeling of the IPs. The IPs and comparator products must be labeled in conformity with the clinical protocol, and the labeling must state that the product is for investigational purposes only.

According to the NDPA CTReg and the G-CTConduct, the IP must be labelled as specified in Additional Resource (A) or Form 38 of the NDPA CTReg. The NDPA CTReg, the G-GMPMedicinalAnnexes, and Additional Resource (A) require the following labeling information to be included on both the outer packaging and the immediate container:

  • 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 pharmaceutical dosage form, route of administration, quantity of dosage units, and strength of active substance
  • The batch number
  • 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 G-GMPMedicinalAnnexes)
  • The product name or unique code (if blinded)
  • The storage conditions and storage temperature
  • The instructions for use
  • The period of use (use-by date, expiration date, or re-test date), in month/year format
  • The product is a clinical trial material (e.g., For Clinical Trial Use Only)

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

The G-TrialsGCP requires that IPs be packaged to prevent contamination and unacceptable deterioration during transport and storage. 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).

Additional Resources
National Drug Authority, Ministry of Health
Investigational Products > Product Management
Last content review/update: May 05, 2020
Requirements
(1) (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
Relevant Sections: Part I (2), Part II (4), Part III (15, 16, and 18), Schedule 1 (Forms 29, 30, 34, and 38), and Schedule 2 (Format for Investigator’s Brochure)
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Uganda (G-CTConduct) (Effective October 14, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 2.0, 4.6.1, 7.3.2, and 10.5.1
(3) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 7.2
(4) (Guidance) Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (G-TrialsGCP) (Effective October 18, 2019)
National Drug Authority, Ministry of Health
Relevant Sections: 4.14-4.16, 5.3-5.5, 7.0-7.3
(5) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 2) (G-GMPMedicinalAnnexes) (Effective March 31, 2020)
National Drug Authority Ministry of Health
Relevant Sections: Annex 13
(6) (Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 3) (G-GMPMedicinal) (Effective March 31, 2020)
National Drug Authority, Ministry of Health
Relevant Sections: Chapter 4
Summary

Overview

In accordance with the NDPA CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP, the sponsor is responsible for providing the investigator(s) with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) including chemical, pharmaceutical, toxicological, pharmacokinetic, and pharmacodynamic data obtained from studies in animals as well as in humans, and the results of earlier clinical trials, if applicable. The information should be presented in a concise, simple, objective, balanced, and non-promotional form that enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial.

According to the NDPA CTReg and the G-TrialsGCP, the sponsor should update the IB as new information becomes available. 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 ethics committee(s) (ECs) (research ethics committees (RECs) in Uganda) and/or regulatory authorities before it is included in a revised IB. The sponsor is responsible for ensuring that an up-to-date IB is made available to the investigator(s), and the investigator(s) is responsible for providing the up-to-date IB to the responsible ECs and the National Drug Authority (NDA).

As specified in the G-GMPMedicinalAnnexes, the sponsor has ultimate responsibility for all aspects of the clinical trial including the quality of the IPs. The increased complexity in manufacturing operations requires a highly effective quality system. However, according to the NDPA CTReg, the principal investigator (PI) is responsible and accountable for the IP.

Investigational Product Supply, Storage, and Handling Requirements

As defined in the NDPA CTReg, the G-TrialsGCP, and the G-CTConduct, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable.

The G-TrialsGCP states that the sponsor should not supply the investigator(s)/institution(s) with the IP(s) until the sponsor obtains NDA and EC approvals. The sponsor is responsible for ensuring that the products are manufactured in accordance with Good Manufacturing Practices (GMPs). Furthermore, 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)).

Per the G-GMPMedicinalAnnexes, the sponsor and manufacturer and/or importer must also agree to written IP retrieval procedures. Further, the sponsor should ensure that the supplier of any comparator or other trial medication has a system in place to communicate any recalls for supplied products. In addition, IPs should be returned on conditions defined by the sponsor and specified in approved written procedures. Returned IPs should be clearly identified and stored in an appropriately secure area. Inventory records of returned IPs should be kept.

The sponsor is also responsible for the destruction of unused and/or returned IPs. IPs should not be destroyed without prior written authorization by the sponsor. Quantities must be specific for each trial site and the sponsor must verify the period. A dated certificate or receipt of destruction should be provided to the sponsor.

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

Record Requirements

As per the NDPA CTReg, the G-CTConduct, the NGHRP, the G-TrialsGCP, and the G-GMPMedicinalAnnexes, the sponsor must ensure maintenance of the following (Note: The regulatory sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • Records documenting IPs shipment, receipt, disposition, return, and destruction
  • A system for retrieving IPs and documenting this retrieval
  • A system to dispose of unused IPs and corresponding documentation
  • Sufficient quantities of the IPs used in the trial to reconfirm specifications, should this become necessary, and maintenance of records of batch samples analyses and characteristics
  • The IB and record(s) of changes made to the IB, if any, including the reasons for these changes
  • A record of adverse events (AEs) of the IP
  • Participant records including their identification(s) and contact(s)
  • A copy of protocol and consent forms

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. The holder of the clinical trial certificate should inform the NDA in writing prior to destroying the documents. Per the NDPA CTReg, trial records for unregistered IPs should be kept for 20 years following the study's completion. Documentation for trials involving IPs to be registered should be kept for two (2) years after the registration of the IP.

Per the G-GMPMedicinal, IP documentation should be retained for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the IP was used.

Investigational Product Importation and Release Requirements

According to the NDPA CTReg, the G-TrialsGCP, and the G-CTConduct, the sponsor should document the shipment and receipt of IPs. The G-CTConduct further indicates that the pharmacist of record must maintain instructions for handling of IP(s) and trial related materials, if not indicated in the protocol or 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.

As per the G-GMPMedicinalAnnexes, the sponsor is responsible for sending a written order to the manufacturer to process, package, and/or ship IPs for a clinical trial. This order should be formally authorized and refer to the Product Specification File and the relevant clinical trial protocol. The Product Specification File is a reference file that contains all of the information necessary to develop written instructions on processing, packaging, quality control testing, batch release, and shipping of an IP.

In addition, during the shipping process, the sponsor maintains IP control until certification by the manufacturer’s Authorized Person and release following fulfillment of relevant requirements on:

  • Batch records
  • Production conditions
  • Validation status of facilities, processes, and methods
  • Examination of finished packs
  • Results of any analyses or tests performed after importation, where relevant
  • Source and verification of conditions of storage and shipment
  • Audit reports concerning the quality system of the manufacturer
  • Documents certifying that the manufacturer is authorized to manufacture IPs or comparators
  • Regulatory requirements

The sponsor must ensure that the IP is consistent with the details in the clinical application and the NDA’s authorization. This can be achieved through a change control process for the Product Specification File and defined in a Technical Agreement between the sponsor and the Authorized Person. The sponsor should record and retain all relevant documentation.

Additional Resources
No additional resources
Specimens > Definition of Specimen
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 10.0
Summary

Overview

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, the following:

  • Blood
  • Urine
  • Stool
  • Saliva
  • Hair
  • Nail clippings
  • Skin
  • Microorganisms
  • Other associated bio-products
Additional Resources
No additional resources
Specimens > Specimen Import & Export
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 10.0
(2) (Guidance) Research Registration and Clearance Policy and Guidelines (G-UNCSTreg) (July 2016)
Uganda National Council for Science and Technology
Relevant Sections: 17.0
Summary

Overview

A permit must be obtained from the Uganda National Council for Science and Technology (UNCST) to conduct a clinical trial using a human biological substance in Uganda.

UNCST Application Requirements

As set forth in the NGHRP and the G-UNCSTreg, when a host institution demonstrates that it lacks the capacity to conduct an adequate investigation of a human biological substance in Uganda, an investigator must submit a request to the UNCST to obtain permission to transfer, export, or exchange samples abroad for research purposes. The request must be accompanied by a Material Transfer Agreement (MTA) between the host institution in Uganda and the recipient institution abroad. 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
  • The governing law in the form of a Memorandum of Understanding (MOU) should be provided
  • 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 collaboration and benefit sharing
  • A framework for accessing and sharing data
  • Restrictions to third party transfer
  • 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
  • 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
  • Specific restrictions for recipient organization should be described
  • 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”
  • The process by which the recipient institution provides annual reports to the host institution and the UNCST on the status of the samples

See Section 10.4 of the NGHRP for detailed MTA requirements.

The investigator must comply with the following requirements:

  • Be a legal resident of Uganda, or be affiliated with a locally recognized institution in Uganda
  • Obtain UNCST registration and approval for the research proposal that involves the transfer, export, or exchange of the human biological substance
  • Submit a letter to the Executive Secretary of the UNCST to obtain permission
  • Submit the MTA and any other documents related to the request

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.

All exchanges and transfers, including importation and exportation of materials for research purposes, require UNCST clearance, except for the exchange of human materials between organizations within Uganda.

Future studies using UNCST approved human biological materials must include a Ugandan scientist as an investigator.

(Refer to the NGHRP and the G-UNCSTreg for additional information.)

Additional Resources
No additional resources
Specimens > Consent for Specimen
Last content review/update: May 05, 2020
Requirements
(1) (Guidance) National Guidelines for Research Involving Humans as Research Participants (NGHRP) (July 2014)
Uganda National Council for Science and Technology
Relevant Sections: 5.3.2, 10.1, 10.2
Summary

Overview

In accordance with the NGHRP, investigators must comply with several informed consent requirements for the acquisition, storage, and future use of human biological samples from research participants in Uganda.

For any research involving the collection of human biological or genetic materials, the investigator must provide an explanation to the research participant in the informed consent form (ICF) regarding how his/her specimens will be managed at the end of the study.

For samples to be stored for future use, the investigator is also required to obtain a separate informed consent from the participant. This process includes the use of a separate ICF that states the following:

  • The purpose of the sample storage
  • The quantities of samples to be stored
  • The location of the stored samples
  • Measures the investigator will take to protect participant confidentiality
  • The policies that will govern the use of the samples in future research
  • The potential risks and benefits of storing samples for future research
  • Any other information deemed necessary by the investigators, the ethics committee, and the Uganda National Council for Science and Technology (UNCST)

The investigator must also give the research participant the right to choose whether his/her samples should or should not be stored for future studies.

Additional Resources
No additional resources
Sections Country Announcement
Country Announcement
x

COVID-19 Guidance

The Uganda National Council for Science and Technology (UNCST) issued the National Guidelines for Conduct of Research during Coronavirus Disease 2019 (COVID-19) Pandemic in July 2020. The guidance aims to assist researchers with complying with COVID-19 prevention and management measures, protecting the rights and safety of research participants and teams, and maintaining research data integrity. The guidelines also describe a joint scientific and ethical review process by all regulatory agencies for COVID-19 clinical trial applications.

African regulatory agencies, ethics committees to expedite COVID-19 clinical trial reviews (April 20, 2020)

This message was updated on August 28, 2020
Are you an expert in Uganda’s clinical research requirements?
x
Click here to learn how you can help keep ClinRegs up to date.
Use the symbols below to refine your search
SymbolExplanation
No symbol At least one of the keywords must be present
Search example: serious adverse event
Result: Will contain serious and/or adverse and/or event
+ Leading plus sign indicates that the word must be present
Search example: serious +adverse event
Result: Will contain adverse and may contain serious and/or event
- Leading minus sign indicates that the word must not be present
Search example: serious adverse -event
Result: Will contain serious and/or adverse but won’t contain event
“ ” Exact phrase must be present
Search example: “serious adverse event”
Result: Will contain the phrase serious adverse event
Call for online focus group participants!
x

ClinRegs content is published in English. ClinRegs offers translations of the content through Google Translate, which is an external translation service. ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages.