Clinical Research Regulation For Australia and DRC

Last content review/update: September 30, 2025

Overview

In accordance with the G-CTHandbook, the G-TrialsSOP, and AUS-86, the Therapeutic Goods Administration (TGA) allows for the supply of unapproved therapeutic goods to be used in clinical trials under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. The G-CTHandbook specifies that the scope of the TGA’s assessment includes all clinical trials (Phases I-IV).

Under either regulatory scheme, per the TGR, the G-CTHandbook, the G-TrialsSOP, and AUS-86, an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve the research protocol. The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC.

According to AUS-40, all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site and whether it has the capacity to conduct the research at that site. Per the G-TrialsSOP, the SSA and ethics review may occur in parallel. However, EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted.

For summaries of the clinical trials regulatory environment, legislation, and guidance, see AUS-40. See AUS-91 for TGA summaries of recent clinical trial reforms.

Clinical Trial Review Process

Per the G-CTHandbook, the sponsor is responsible for the overall decision as to whether the CTN or CTA scheme should be used. Consulting the EC responsible for protocol approval may assist the sponsor in making the decision. The main difference between the CTN and CTA schemes is the TGA’s level of involvement in reviewing data about the therapeutic goods before the clinical trial commences.

However, as noted in AUS-88, the CTA scheme is mandatory for certain Class 4 biologicals. See AUS-86 for more general information on choosing a clinical trial scheme.

CTN Scheme

As per the G-CTHandbook, the G-TrialsSOP, and AUS-87, under the CTN scheme, the sponsor must notify the TGA of its intention to sponsor a clinical trial involving an unapproved therapeutic good. The TGA does not assess any data relating to the proposed trial at the time of notification. AUS-87 further notes that some ECs and institutions may need the TGA’s acknowledgement before beginning their own approval processes. In these cases, the TGA will accept a CTN submission while the sponsor gets the required approvals from the EC and institution. However, it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial.

The G-CTHandbook and AUS-87 indicate that a clinical trial is deemed to be notified as soon as the online CTN form (via the TGA Business Services (TBS) webpage (AUS-36)) has been submitted and the relevant fee has been paid. If there are any changes/variations to the trial details notified to the TGA, the sponsor must update the relevant fields on the online CTN form. AUS-87 notes that some changes/variations (such as the addition of a new site to a trial, a change to the notified therapeutic good that creates a separate and distinct good, or the addition of a new therapeutic good to a previously notified trial) will incur a fee.

The G-CTHandbook further states that the TGA may request additional information if the trial raises any concern, or ask specific questions to address any deficiencies. Specifically, the TGA can request certain information or documents from the sponsor relating to the supply and handling of the goods, as well as the monitoring and results of the supply of the goods. If the TGA directs a trial notified under the CTN scheme not to be conducted or becomes aware that conducting or continuing the trial would be contrary to the public interest, then the goods used in the trial would no longer be exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG) (AUS-22) and cannot be lawfully supplied. This may occur if the TGA becomes aware that allowing the trial to proceed or continue carries an unacceptable risk of death, serious illness, or serious injury.

CTA Scheme

AUS-88 indicates that the CTA scheme involves an application to the TGA for approval to supply an unapproved therapeutic good(s) in a clinical trial, where the TGA will evaluate scientific data about the therapeutic good(s) (quality, preclinical, and early clinical safety data) prior to the start of a trial. The sponsor can, either following TGA approval or in parallel with the TGA’s evaluation, contact their chosen EC to initiate the EC’s review of the scientific and ethical details of the trial proposal. However, trials can only commence once both TGA and EC approvals have been received.

According to AUS-88, the TGA is in the process of reviewing the CTA scheme. Stakeholders seeking more information on the CTA process are encouraged to contact the TGA at clinical.trials@health.gov.au. Sponsors planning to submit a CTA application are also encouraged to request a pre-submission meeting with the TGA. See the Submission Process section for more information on pre-submission meetings.

AUS-88 states that after the sponsor submits the CTA application form and supporting data, the TGA generally conducts a preliminary assessment to ensure that the data is sufficient to begin evaluation. If there is critical data missing, the TGA will request further information. Once it is satisfied that there is sufficient data/information to commence evaluation, the TGA will send an invoice. The TGA’s evaluation begins after the sponsor pays the fee. During its review, the TGA generally evaluates the quality of the therapeutic good, the safety of the therapeutic good, compliance with applicable Therapeutic Goods Orders (TGOs) (see AUS-93), compliance with international guidelines, and labelling (including traceability). The evaluation process usually consists of two (2) rounds of evaluation and one (1) round of request for information from the sponsor. Additional rounds may be required if there is outstanding information required to support the evaluation process or decision.

As delineated in AUS-88, evaluation reports with recommendations are then submitted to the decision maker, a TGA senior medical officer, for consideration. The decision maker considers the overall risk-benefit profile of the trial, which may include TGA evaluation reports; the trial’s usage guidelines (such as the trial protocol, investigator’s brochure, literature references, and pharmacy guidelines); and plans for shipment and storage at trial sites. The decision maker may seek expert advice from TGA statutory advisory committees. The TGA will inform the sponsor in a letter of the decision whether to approve the trial or not.

AUS-88 further states that if a sponsor wishes to change the therapeutic good(s) or any aspect of the clinical trial that was evaluated in the original CTA submission, a variation requiring additional evaluation by the TGA may be required. These changes are assessed to ensure that the quality and safety of the good(s), or the overall risk-benefit profile of the trial, will not be inadvertently altered by the variation. Examples may include significant changes to the manufacturing process, intended patient group, route of administration, and/or container. CTA variations incur a fee. Any changes that were not evaluated in the original submission or are predicted to have no effect on the therapeutic good or safety of the trial will not be assessed by the TGA. However, all changes should be communicated to and approved by the EC before commencement. Sponsors are encouraged to contact the TGA at clinical.trials@health.gov.au for specific advice on what constitutes a variation to a previously approved CTA application.

As indicated in the G-CTHandbook, the TGA can revoke an approval of a clinical trial under the CTA scheme where the conditions of approval are not met.

Inspection

According to the G-GCP-Inspect, clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA’s Good Clinical Practice (GCP) inspection program. The TGA can conduct a GCP inspection, which typically occurs over one (1) to three (3) consecutive days, at any stage of the clinical trial lifecycle from the early phase of participant recruitment to completed trials. Additionally, the TGA can request certain information or documents about therapeutic goods exempt under the CTN scheme or approved under the CTA scheme. This can include the investigator’s brochure and protocol, further information about safety reports, clarification about the safety profile of a specific therapeutic good, and/or details of problems or complaints. The TGA will normally give advance notice of its intention to conduct a GCP inspection but has the right to perform an inspection at any time. In exceptional circumstances, the TGA can perform an inspection without notice.

See the G-GCP-Inspect for more details on how the TGA prioritizes and schedules GCP inspections, the kinds of inspections the TGA might conduct, the inspection process, and how the TGA reports and follows up on inspections. See AUS-90 for more information on the TGA’s GCP inspection program.

About this handbook, Is the product a therapeutic good?, Determine if the product is ‘unapproved’, Choosing between the CTN and CTA schemes, The CTN scheme, The CTA scheme, and Responsibilities under the CTN and CTA schemes

Introduction, Terms, and SOP 05

Purpose, Scope and Limits of this Document

Preparing for an Inspection, Inspection Process, and During an Inspection

Part 3 (12 and 12AA-12AD) and Schedule 5A

Last content review/update: November 27, 2024

Overview

According to D-ACOREP, the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) is the regulatory authority responsible for regulating clinical trials, as well as authorizing and controlling drug imports and exports, in the Democratic Republic of the Congo (DRC). In addition, the G-EthicalEval indicates that an ethics committee (EC) must review the scientific validity and ethical acceptability of any research proposal involving human subjects.

As per the G-EthicalEval, the study protocol must be submitted to the EC for review concurrently with a request to ACOREP for study authorization and registration. Therefore, regulatory and ethics reviews are conducted in parallel. However, ACOREP approval is contingent upon EC approval. Per DRC-12, ACOREP accepts ethics review from any approved local EC.

Clinical Trial Review Process

DRC-12 states that upon receiving a clinical trial application, ACOREP screens it for completeness. The G-EthicalEval indicates that in the event of a favorable opinion from the EC, ACOREP decides whether to approve the trial. If the EC issues an adverse opinion, ACOREP cannot authorize the study.

Per DRC-12, ACOREP issues a decision on approving or denying complete applications within 30 days. The decision is sent to the principal investigator (PI) by email, or the PI can pick up a hard copy of the decision at the secretariat of ACOREP.

Title II (Articles 3-4)

Guidelines 4 and 5

Regulatory Fees

Last content review/update: September 30, 2025

Therapeutic Goods Administration

As per the TGR, the sponsor is responsible for paying a fee to the Therapeutic Goods Administration (TGA) to submit an application under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) scheme for evaluation. Per the G-FeesCharges, the fees are as follows:

$443 Australian dollars for unapproved medicines CTN, and for each notification of one (1) or more additional trial sites
$2,111 Australia dollars for unapproved medicines CTA (30-day evaluation)
$580 Australian dollars for unapproved medicines CTA – variation (30-day evaluation)
$26,240 Australian dollars for unapproved medicines CTA (50-day evaluation)
$7,162 Australian dollars for unapproved medicines CTA – variation (50-day evaluation)
$443 Australian dollars for unapproved biologicals CTN, and for each notification of one (1) or more additional trial sites
$31,955 Australian dollars for unapproved biologicals CTA
$8,718 Australian dollars for unapproved biologicals CTA – variation

For additional fee information, refer to Schedules 9 and 9A of the TGR and the G-FeesCharges.

Payment Instructions

AUS-66 indicates that regulatory fees and charges may be paid online or by bank transfer (electronic funds transfer (EFT)). Online payment by credit card is the preferred payment option, and all payments must be in Australian dollars.

As stated in AUS-25, online payment is made via the TGA Online Payment Portal (AUS-16). Once the payment has been finalized, the Portal will confirm that the payment has been successful. The user may request an email confirmation. Certain payments, including a CTN fee and a variation to a medicine (e.g., a therapeutic good), may be made online without an invoice. See AUS-25 for more information on TGA fees and payments. Also see AUS-49 for additional guidance and system screenshots related to paying CTN fees.

AUS-66 further indicates that to ensure all payments made by EFT are correctly allocated, the organization’s Identification Number (e.g., TGA00xxxxx) should be included in the payment ‘Reference’ field. Bank transfer fees are the payer’s responsibility. Additionally, bank transfers must be accompanied by a remittance advice, which must be issued within 24 hours for all bank transfers. Remittance advices must be emailed to TGARemittanceAdvices@health.gov.au and contain the organization’s Identification Number in the subject field. The TGA’s bank account details are as follows:

Bank: Commonwealth Bank of Australia
BSB: 062-909
Account Number: 10215498

Per AUS-66, payments from overseas can only be accepted in Australian denominations. Payers must ensure that their payment covers any international banking fees. The TGA’s international banking details are as follows:

IBAN: 06290910215498
Swift Code: CTBAAU2S

Paying for Your CTN

Clinical Trials

Schedules 5A, 9 (Part 2), and 9A (Part 2)

Last content review/update: November 27, 2024

Congolese Pharmaceutical Regulatory Authority (ACOREP)

According to DRC-12, the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) charges a fee for the submission of a clinical trial application, in accordance with a fee schedule. Applicants should contact ACOREP for the fee schedule.

Payment Instructions

No information is available regarding payment instructions.

Ethics Committee

Last content review/update: September 30, 2025

Overview

As indicated in the TGAct, the TGR, the G-CTHandbook, the G-NatlStmt, and AUS-86, Australia has a decentralized process for the ethics review and approval of clinical trial research. According to the TGR, the G-CTHandbook, the G-TrialsSOP, and AUS-86, Australia requires human research protocols to be reviewed by an institutional-level ethics committee (EC). The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC. (Note: Institutional ECs are referred to as Human Research Ethics Committees (HRECs) in Australia.)

The G-NatlStmt indicates that one (1) or more institutions can individually or jointly establish an EC or any other ethics review body. Institutions that establish an EC are responsible for adequately resourcing and maintaining it, including providing sufficient administrative support. Per the TGAct and AUS-20, ECs are required to be constituted and operate in accordance with the guidelines issued by the National Health and Medical Research Council (NHMRC), and to have notified the NHMRC of their existence. According to the TGR, the G-NatlStmt, the G-TrialsSOP, and AUS-20, institutional ECs ensure that clinical trial research complies with the NHMRC’s ethical standards published in the G-NatlStmt. See the Oversight of Ethics Committees section for more information on notification.

For summaries of the clinical trials regulatory environment, legislation, and guidance, see AUS-40.

Ethics Committee Composition

As stated in the G-NatlStmt, an EC must be composed of at least eight (8) members in the following categories:

A chairperson with suitable experience
Two (2) people who bring a broader community or consumer perspective and have no paid affiliation with the institution
One (1) person with knowledge of and current experience in the professional care, counseling, and/or treatment of people
One (1) person who performs a pastoral care role in the community
One (1) qualified lawyer, who may or may not be currently practicing and, where possible, is not engaged to advise the institution on research-related or any other matters
Two (2) people with current research experience relevant to the research proposals to be considered at the meetings they attend

The G-NatlStmt further states that wherever possible, one (1) or more of the members listed above should be experienced in reflecting on and analyzing ethical decision-making. As far as is practicable, institutions should ensure that their EC’s membership at each meeting has diversity, including gender diversity, and at least one third of those participating in each meeting are from outside of the institution. ECs that review research about Aboriginal and Torres Strait Islander people or communities should appoint one (1) or more members who have knowledge of research with Aboriginal and Torres Strait Islander peoples or are familiar with relevant cultural knowledge, if such a person has not already been appointed.

Per the G-NatlStmt, ECs may also include other members with the above areas of expertise or with additional areas of expertise. Institutions are encouraged to establish a pool of appointed EC members to draw on as needed to help meet minimum membership requirements and/or provide additional experience or expertise. The institution should ensure that its EC has access to the expertise necessary to properly review research, which may necessitate going outside of the EC’s membership.

Terms of Reference, Review Procedures, and Meeting Schedule

As delineated in the G-NatlStmt, institutional ECs must ensure that it documents, implements, and publicizes standard operating procedures (SOPs) that promote good ethics review, including:

Meeting frequency, attendance, and conduct
Minutes and agenda preparation
Timely distribution of materials to members before meetings
Timely consideration of applications
Methods of deliberation and decision-making
Processes, if any, for reviewing applications from unaffiliated or international researchers
Disclosure of interests and management of conflicts of interest
Appropriate confidentiality of the content of applications and the deliberations of review bodies
Prompt notification of decisions to researchers
Communicating with researchers, including face to face, by telephone and in writing, (including available forms of electronic communication)
Record keeping
Monitoring of approved research
Reporting and handling of adverse events
Receiving and handling of complaints
Advising the institution(s) of decisions to suspend or withdraw ethics approval of research projects
Attendance of people other than members at meetings

Pursuant to the G-NatlStmt, EC members should be familiar with the G-NatlStmt and other relevant guidelines; prepare for and attend EC meetings or, if unavailable, provide opinions before the meetings; and attend research ethics training programs or continuing education at least every three (3) years. Members should be appointed to an EC using open and transparent processes, and institutions should consider reviewing appointments to the EC at least every three (3) years.

The G-NatlStmt states that as far as possible, each EC meeting should be arranged to enable attendance of all members of the minimum membership categories listed above and other relevant appointed members, either in person or via available technology. Meeting papers should be provided enough in advance to enable members to be fully informed. An EC’s decision about whether a research proposal meets the requirements of the G-NatlStmt must be informed by an exchange of opinions from all members of the EC participating in the meeting. The exchange should, ideally, take place at a meeting with all those members present. Where there is less than full attendance of the minimum membership categories at a meeting, the chairperson must be satisfied, before a decision is reached, that the views of those absent who belong to the minimum membership have been received and considered. The EC should attempt to reach decisions by general agreement or consensus. Voting is neither required nor prohibited. Some decisions may not be unanimous, and a dissent should be recorded in the minutes of the meeting. Where requested by a dissenting member, the reasons for the dissent should also be recorded in the minutes of the meeting.

According to the G-NatlStmt, ECs may invite researchers, and researchers may request, to be present for discussion of their proposed research. In addition, ECs may seek advice from external experts to help in considering a research proposal. Communication between the sponsor and the EC is not prohibited but should be restricted so that it does not inappropriately influence the review of any relevant research proposals.

As delineated in the G-NatlStmt, ECs must maintain a complete record of all research proposals received and reviewed. Approved project documentation and any relevant correspondence must also be retained. Records must be maintained in accordance with the requirements of relevant Commonwealth and state or territory legislation and guidelines. See G-NatlStmt for detailed records requirements.

For more details on the governance and responsibilities of Australian institutional ECs, see the G-NatlStmt.

The CTN and CTA schemes and Responsibilities under the CTN and CTA schemes

Terms

Purpose, Scope and Limits of this Document, and Section 5 (Chapters 5.1 and 5.2)

Chapter 1 (3) and Chapter 3 (Part 3-2 (18 and 19))

Part 3 (12AA and 12AD) and Schedule 5A

Last content review/update: November 27, 2024

Overview

According to the G-EthicalEval, any research proposal in the Democratic Republic of the Congo (DRC) involving human participants must be submitted for evaluation of its scientific validity and ethical acceptability to an ethics committee (EC). An EC may be established under the auspices of national or local health authorities, national (or centralized) medical research councils, or other national representative bodies. Additionally, the EC must be independent of the research team and approved by the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention).

Order1250-ZKM043 indicates that the purpose of the DRC’s national EC, the National Committee of Health Ethics (Comité National d'Éthique de la Santé (CNES)), is to review proposals for research on human beings based on the ethical principles of respect for the individual, beneficence, and justice. The CNES is also responsible for promoting the creation of and accrediting institutional ECs across the country, among other duties.

Ethics Committee Composition

The G-EthicalEval indicates that an EC should be made up of physicians, scientists, and representatives of other groups, such as nurses, lawyers, ethicists, and non-professionals, who are able to represent the cultural and moral values of the community and uphold the rights of the research participants. An EC must include both men and women.

According to the G-EthicalEval, to ensure the EC is composed of members that have experience as well as new members with a fresh perspective, a certain number of EC members may be renewed periodically. In addition, to ensure the independence of ECs and to avoid any conflict of interest, any members of the committee having special interests, direct or indirect, in a research proposal must exclude themselves from the evaluation of the proposal.

National Committee of Health Ethics (CNES)

As per Order1250-ZKM043, the CNES has 40 members, including:

One (1) delegate per province from institutional ECs
Scientific individuals (at most 10)
Religious individuals (at most five (5))
A delegate from the Order of Physicians
A delegate of the Order of the Pharmacists
A delegate from other health professional associations
A delegate from the Health Administration

Additionally, Order1250-ZKM043 states that CNES members are recruited on the basis of the following criteria:

Proven moral and scientific reputation
Professional experience of at least five (5) years
Practical training in bioethics
Great availability
Community leadership

Order1250-ZKM043 further indicates that CNES’ mandate is five (5) years, which is renewable once. The CNES is governed by an office composed of a president, a vice-president, a secretary-rapporteur, a deputy secretary-general, and a treasurer, all elected by and from among the members. The government’s Public Health authority appoints members of the office.

Terms of Reference, Review Procedures, and Meeting Schedule

The G-EthicalEval states that the EC’s written procedures must define all EC operating standards.

According to the G-EthicalEval, an EC must clearly define the roles necessary for smooth ethical evaluation. The different roles within the EC (such as president and secretary), the requirements of each role, the terms and conditions of attaining a role, and the duties and responsibilities associated with the roles must be detailed in writing.

As per the G-EthicalEval, EC members should receive basic training and access to continuing education on the ethical and scientific aspects of biomedical research. The conditions of appointment should detail the arrangements for providing EC members with initial training on the EC's work, as well as opportunities to strengthen their expertise in conducting an ethics review. These provisions should also include the requirements or expectations for basic and continuing education of EC members. This training can be carried out in the context of cooperation with other ECs in the country or region, and also on other occasions favorable to the basic training and the continuous training of the EC’s members.

The G-EthicalEval indicates that the EC is responsible for establishing well-defined procedures for submitting an application for review. These procedures, as well as any standard forms, must be public and available to applicants. In order to aid researchers, it is desirable that these procedures and forms be harmonized among all the active ECs in the country.

The G-EthicalEval requires that ECs establish specific quorum requirements to review a proposal and make a decision. These requirements must include or specify at least the following:

The minimum number of members required to reach a quorum
The professional qualifications required and distribution of these requirements within the quorum
No quorum shall be composed exclusively of members of the same profession or the same sex
The quorum must include at least one (1) member whose primary area of expertise is not scientific and at least one (1) independent member of the institution or research site

The G-EthicalEval further requires that an EC meet regularly, on scheduled dates announced in advance in a publicly available calendar. The meeting requirements must include or specify at least the following:

Meetings should be scheduled according to a pre-established schedule, which can be modified according to the workload
EC members should have sufficient time, defined before the meeting, to review submitted documents
Meetings must be documented in minutes, and there must be a procedure for approval of the minutes
The applicant, the sponsor, and/or the investigator may be invited to present their proposal or to elaborate on certain specific points
Independent consultants may be invited to the meeting or provide written comments, subject to the confidentiality agreements in force
The EC must send its opinion within 15 days of the meeting

National Committee of Health Ethics (CNES)

According to Order1250-ZKM043, the CNES’ operating mode and the frequency of meetings are determined by internal regulations previously submitted to the Minister of Health for review. The CNES operates in committees and may create, as needed, ad-hoc subcommittees for specific problems. Additionally, the CNES may call upon any resource person whose expertise or experience can be used to resolve or address a problem. The CNES draws up its action plan and activity reports and is subject to the authority of the Ministry of Health, to which it reports.

Guidelines 5, 6, 9, 10, 12, 13, and 15

Title I (Articles 1 and 2), Title II (Article 4), Title III (Articles 6-10), and Title IV (Articles 11-14)

Scope of Review

Last content review/update: September 30, 2025

Overview

According to the G-NatlStmt, the institutional ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) is responsible for protecting the interests of research participants and for promoting good research by ensuring adherence to the values of research merit and integrity, beneficence, justice, and respect for persons throughout the conduct of the research project. The EC must review the recruitment and consent processes, weigh the benefits and risks of the research, and consider the impact of the research on certain groups of participants deemed to merit special consideration. Additionally, ECs may conduct both scientific and ethics review or may delegate scientific review to a sub-committee.

Pursuant to the G-NatlStmt, the establishment and maintenance of ethics review processes and processes for assessing the risk level of the research are part of an institution’s overall governance responsibility. In addition to ethics approval, research must also be authorized by each institution with responsibility for oversight of the research before it can proceed. See the Oversight of Ethics Committees, Submission Process, Submission Content, Timeline of Review, and Initiation, Agreements & Registration sections for more information on research governance requirements.

Role in Clinical Trial Approval Process

According to the G-CTHandbook, the G-TrialsSOP, and AUS-86, ECs are responsible for reviewing and approving protocols involving unapproved therapeutic goods under one (1) of two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme—prior to the sponsor initiating a trial. According to AUS-40, all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site, and whether it has the capacity to conduct the research at that site. Per the G-TrialsSOP, the SSA and ethics review may occur in parallel. However, EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted.

The G-CTHandbook states that a CTN scheme is a notification scheme under which the Therapeutic Goods Administration (TGA) does not review or evaluate any data relating to the clinical trial. The EC is responsible for assessing the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good(s), and the overall ethical acceptability of the trial. AUS-87 notes that some ECs and institutions may need the TGA’s acknowledgement before beginning their own approval processes. In these cases, the TGA will accept a CTN submission while the sponsor gets the required approvals from the EC and institution. However, it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial.

Under the CTA scheme, as delineated in the G-CTHandbook, the TGA reviews relevant, but limited, scientific data, while the EC is responsible for considering the scientific and ethical issues of the proposed trial protocol. AUS-88 indicates that the sponsor can, either following TGA approval or in parallel with the TGA’s evaluation, contact their chosen EC to initiate ethics review of the CTA scheme trial proposal. However, trials can only commence once both TGA and EC approvals have been received.

Per the G-CTHandbook, the sponsor determines whether to conduct a clinical trial under the CTN or CTA scheme. Consulting the EC responsible for protocol approval may assist the sponsor in making the decision. One of the determining factors for an EC is whether the committee has access to appropriate scientific and technical expertise in order to assess the safety of the product. If an EC feels that it requires additional expertise to review a CTN, it may seek advice from external authorities or it may seek to collaborate with another EC that has the required expertise. An EC may also determine that it does not have access to the appropriate scientific and technical expertise to review the proposed trial under the CTN scheme and recommend review under the CTA scheme.

AUS-14 states that prior to approving a clinical trial, the EC must be satisfied that the trial protocol complies with the following requirements:

G-NatlStmt
Declaration of Helsinki (AUS-52)
AU-ICH-GCP
TGA requirements, including the G-CTHandbook and the G-SafetyDataMgt
Any relevant Australian Government and/or state/territory laws

The G-CTHandbook and the TGR state that during its review, the EC also needs to be aware of relevant state and territory laws pertaining to the supply of therapeutic goods or other clinical trial-related matters. The G-CTHandbook further indicates that ECs have a high level of independence and are responsible for establishing their own processes for reviewing research proposals. According to the G-CTHandbook and the AU-ICH-GCP, if requirements specified in the G-NatlStmt appear to differ from those specified in the AU-ICH-GCP, the TGA recommends compliance with the G-NatlStmt.

As stated in AUS-20, ECs also consider the protection of privacy for humans participating in research and their data. ECs do this by considering whether the research proposal conforms to relevant legislation, principles, and guidelines, including federal and/or state/territory legislation as well as the G-PrivacyAct95 and G-PrivacyAct95A guidelines. See the Personal Data Protection section for more information.

Per the G-NatlStmt, an EC may approve, request modification of, reject, or withdraw approval of a research proposal. The EC must clearly communicate its decision to the researcher(s):

Where a proposal is approved or rejected, or where approval is withdrawn, communication must be in writing (which may include electronic formats) and should include an explicit statement that the proposal meets or did not meet the requirements of the G-NatlStmt. If rejecting or withdrawing approval of a research proposal, the EC should provide the rationale for its decision, including citing the provisions of the G-NatlStmt or relevant institutional policy that underpins its decision, if relevant.
Where modifications are requested, communication may be written or, where appropriate, informal; however, a record should be kept of any informal communication, and guidance should be clearly communicated regarding to whom the researcher’s response should be directed.

According to the G-NatlStmt, varying processes may be used for the review and approval of project extensions, amendments to an approved project, progress reports, and renewal of project approval. Appropriate processes depend on the nature of the original project and any proposed changes, but any process authorized by an institution for these purposes must prioritize the safety and well-being of participants, researchers, and/or the community.

Pursuant to the G-CTHandbook and the TGR, when the EC approves a trial protocol, it takes responsibility for monitoring the progress and conduct of the trial. However, the G-NatlStmt indicates that each institution has ultimate responsibility for ensuring, via its research governance arrangements, that all its authorized research is monitored. Monitoring arrangements should be commensurate with the risk, size, and complexity of the research. Monitoring responsibilities that are performed by the institution’s EC should be based on the EC’s review of the project. However, where research that will take place at multiple sites has been reviewed by only one (1) EC, the ECs of the other institutions participating in the project do not have knowledge of the project. In such cases, only the reviewing EC can take on those elements of monitoring a research project that are commonly performed by ECs.

Per the G-NatlStmt, if the EC or institution has reason to believe that continuance of a research project would compromise participants' welfare, or if the conditions of ethics approval for the project are not being adhered to, it should immediately seek to establish whether ethical approval for the project should be suspended or withdrawn. If an institution or EC considers that suspension of research is necessary, the instruction to stop should come from the management of the institution. If ethics approval for a research project is suspended, the researcher, the institution(s), and, where possible, the participants should be informed of the suspension.

As indicated in the G-NatlStmt, ECs may require researchers to amend research procedures to protect participants. If an EC determines that such changes cannot achieve that end, the EC may decline to grant an extension to project approval or decide to withdraw approval for the research. Where ethics approval for a research project is withdrawn:

The researcher, the institution(s), and, where possible, the participants should be informed of the withdrawal
Continuation of the research project is subject to re-application and re-approval by the EC

See the G-NatlStmt for more details on institutional and EC responsibilities regarding research monitoring.

External Ethics Approval and the National Mutual Acceptance Scheme

The G-NatlStmt encourages the minimization of unnecessary duplication of ethics review, including for research conducted in multiple Australian jurisdictions or across international boundaries. Institutions may accept an ethics review conducted by an entity external to the institution (including overseas review bodies) and should determine their criteria for this acceptance.

Per the G-NatlStmt, researchers who wish to submit evidence of ethics approval by an external EC in support of single ethics review should be aware of existing national or international programs, protocols, policies, standards, and guidance that may be relevant to the institutional decision to accept the review. To facilitate the efficient ethics review of research, researchers must inform any EC of:

All sites at which the research will be conducted
Any information on local site circumstances that is relevant to the ethics review
Any other body that will be considering ethical issues related to the research
Any previous decisions to approve, re-consider, or deny approval of the research by another review body in Australia or elsewhere

See the G-NatlStmt for more information on external ethics approval.

As described in AUS-21 and AUS-41, the National Mutual Acceptance (NMA) scheme further supports the acceptance of a single scientific and ethical review of multicenter research conducted in publicly funded health services. All state and territory-certified public health organizations in Australia are part of the NMA scheme.

Per AUS-68, in order for ethics reviews of human research to be accepted under NMA, the EC conducting the review must be certified under the National Health and Medical Research Council (NHMRC) National Certification Scheme of Institutional Processes Related to the Ethical Review of Multi-centre Research (National Certification Scheme), and also be a “Certified Reviewing HREC” under the NMA scheme.

For more information on submissions to ECs under the NMA scheme and the National Certification Scheme, see the Submission Process and Oversight of Ethics Committees sections.

Exemption from Ethics Review

As stated in the G-NatlStmt, some research may be eligible for exemption from ethics review. Where appropriate, exemption is granted, or not, by the institution responsible for the research. Where there is no institution providing oversight of the research, researchers should request a grant of exemption from an EC. Research that may be eligible for exemption from ethics review includes research that carries a lower risk to participants or the community, and satisfies one (1) or more of the following conditions:

The research involves the use of collections of information or data from which all personal identifiers have been removed prior to being received by the researchers, and where researchers explicitly agree: (i) not to attempt to re-identify those with whom the information or data is associated; (ii) to take all reasonable steps to prevent re-identification of the information or data for unauthorized purposes or access to the information or data by those who are not authorized; and (iii) that any sharing of any research data during or after the project will not create any additional risks of re-identification of the information or data
The research is restricted to surveys and observation of public behavior using information that was or will be collected and recorded without personal identifiers and is highly unlikely to cause distress to anyone associated with the information or the outcomes of the research
Is conducted as part of an educational training program in which the research activity is for training purposes only and where any outcomes or documentation are for program use only
The research uses only information that is publicly available through a mechanism set out by legislation or regulation and that is protected by law, such as mandatory reporting information, information obtained from registries of births and deaths, coroner’s investigations, or reports of the Australian Bureau of Statistics

The G-NatlStmt indicates that institutions or other granting bodies must keep a record of any decision to grant exemption from ethics review. See the G-NatlStmt for more information on ethics review exemption.

State and territory ethics review processes

Health Privacy

Clinical trials involving therapeutic goods, The CTN and CTA schemes, and Responsibilities under the CTN and CTA schemes (Role of Human Research Ethics Committees (HRECs))

3

Terms and SOP 05

Purpose, Scope and Limits of this Document, and Sections 1 (Introduction and Guidelines), 2, 3 (Introduction), 4, and 5 (Chapters 5.1-5.2 and 5.4-5.5)

Part 3 (12 and 12AA-12AD) and Schedule 5A

Last content review/update: November 27, 2024

Overview

The G-EthicalEval indicates that the main task of an ethics committee (EC) is to review research proposals and supporting documents, with particular attention to the process of obtaining informed consent, documentation, and the relevance and feasibility of the protocol. The EC must take into account previous scientific and ethical assessments, if any, and the requirements of applicable laws and regulations. An EC may perform its function at the institutional, local, regional, or national level.

According to the G-EthicalEval, ECs are responsible for protecting the rights of research participants, their safety, and their well-being. ECs must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, methods, and scientific design of the study; assessing the participant recruitment process; and verifying the adequacy of confidentiality and privacy safeguards.

Role in Clinical Trial Approval Process

According to the G-EthicalEval, the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention)’s Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) and the EC must approve a clinical trial application for research involving human participants prior to the sponsor or the principal investigator (PI) initiating the clinical trial. The G-EthicalEval further specifies that the PI must submit the request for ethics review. Per DRC-12, ACOREP accepts ethics review from any approved local EC.

As per the G-EthicalEval, the study protocol must be submitted to the EC for review concurrently with a request to ACOREP for study authorization and registration. Therefore, regulatory and ethics reviews are conducted in parallel. The EC must communicate its opinion on the protocol to the PI. A copy of the EC’s opinion should be sent to ACOREP. EC approval of the protocol must be obtained before ACOREP may approve the trial. In the event of a favorable opinion from the EC, ACOREP decides whether to approve the trial. If the EC issues an adverse opinion, ACOREP cannot authorize the study. However, the PI may resubmit the protocol to the EC after modifying the elements that led to the adverse opinion.

According to the G-EthicalEval, ECs must establish procedures for expedited review of research proposals. These procedures must address certain processes, including the nature of the requests, amendments, and other considerations acceptable for expedited review, as well as the quorum requirements for expedited review.

As per the G-EthicalEval, ECs must also establish a procedure for monitoring the progress of all research that has been approved, from the date the decision was made to the end of the research. The follow-up intervals should be determined by the nature of the study and other events, although each protocol should be monitored at least once a year during the recruitment period. The EC must review and approve any protocol amendments prior to those changes being implemented.

The G-EthicalEval also indicates that the PI must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3).

There is no stated expiration date for an EC approval in the G-EthicalEval.

(See the Submission Process section for detailed submission requirements.)

1.25, 4, 5.5

Guidelines 4, 5, 13, 16, 17, 20, 33, and 35

Ethics Committee Fees

Last content review/update: September 30, 2025

The G-NatlStmt indicates that when establishing an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia), an institution must set out and publicize its terms of reference, including its schedule of fees charged, if any, for ethics review. The institution is responsible for ensuring that its EC operates in accordance with the G-NatlStmt, which includes being satisfied that any fees charged for EC review do not discourage research that the institution has an obligation to support.

Section 5 (Chapter 5.1)

Last content review/update: November 27, 2024

According to the G-EthicalEval, an ethics committee (EC) may charge a fee for the ethical and scientific evaluation of research protocols, to be directed toward its operating costs. The fee must be a predetermined public rate and should not exceed 2% of research costs, excluding the cost of investment. Applicants should contact ECs individually for specific fees and payment instructions.

Guideline 5

Oversight of Ethics Committees

Last content review/update: September 30, 2025

Overview

As per the TGAct, the G-TrialsSOP, and the G-CTHandbook, the National Health and Medical Research Council (NHMRC) is responsible for receiving applications from ethics committees (ECs) (Human Research Ethics Committees (HRECs) in Australia) to be registered. The NHMRC was established by the NHMRCAct. Per the NHMRCAct, the NHMRC’s activities are designed to raise the standard of individual and public health throughout Australia; to foster the development of consistent health standards between the various states and territories; to foster medical and public health research and training throughout Australia; and to foster consideration of ethical issues relating to health.

Research Governance

Pursuant to the G-NatlStmt, institutions may fulfill their research governance responsibilities by establishing and overseeing different levels of ethics review. One (1) or more institutions can individually or jointly establish an EC or any other ethics review body. Institutions that establish an EC are responsible for adequately resourcing and maintaining it, including providing sufficient administrative support.

According to the G-NatlStmt, institutions should ensure that all ethics review processes and the criteria that are used for determining the appropriate process are clear, transparent, and published to enable researchers to submit their research proposals efficiently.

The G-NatlStmt further states that institutions should clearly publicize their policy for access to their EC or other ethics review processes by researchers who are not affiliated with the institution. Additionally, institutions should regularly assess all their ethics review processes, including the criteria for allocating research to different levels of review, to ensure that those processes continue to enable the institution to meet its responsibilities under the G-NatlStmt. Where possible this assessment should be informed by the documented experience of research participants and/or by involving participants or the wider community in the assessment.

Furthermore, as delineated in the G-NatlStmt, institutions should have in place an auditing process to confirm that research is being reviewed at the levels of review that their criteria require and research is being exempted from review only in accordance with the criteria set out in the G-NatlStmt. See the Scope of Review section for more information on exemption criteria.

Registration, Auditing, and Accreditation

According to the G-NatlStmt, institutions that have responsibility for oversight of research and maintain ECs must register their ECs with the NHMRC. ECs that are not associated with institutions must register themselves with the NHMRC.

Per AUS-20, registration means that the EC has notified the NHMRC of its existence and declared that it meets the requirements of the G-NatlStmt. In order to review and monitor clinical trials of unregistered therapeutic goods, an EC must be notified to the NHMRC, and constituted and operating in accordance with the G-NatlStmt. Forms for registering an EC, notifying the NHMRC of changes to the EC, or terminating an EC’s registration are available at AUS-20.

As per the G-NatlStmt, an institution and its EC must report annually, or upon request, to the NHMRC. The NHMRC, through the Australian Health Ethics Committee (AHEC), will review the activities of ECs to ensure conformance with the G-NatlStmt. Reportable information may include:

Membership/membership changes
Number of meetings
Confirmation of participation in meetings by members in minimum membership categories
The number of research proposals presented, the number approved, the number requiring modification prior to approval, and the number rejected
Monitoring procedures that are in place and any problems encountered with project monitoring
Complaints procedures and number of complaints handled
Any other relevant policies, procedures, or processes as determined by the NHMRC

The G-NatlStmt further indicates that failure to comply with the requirements of the G-NatlStmt may result in the EC being removed from the list of ECs registered with NHMRC. See AUS-20 for more information and the list of registered ECs.

National Certification Scheme

According to AUS-21, the NHMRC developed the National Certification Scheme of Institutional Processes Related to the Ethical Review of Multi-centre Research (National Certification Scheme) to enable the single ethics and scientific review of human research occurring at multiple institutions in Australia. Under this scheme, certified institutions can have their ethics review accepted by other institutions participating in the research project. As part of the National Certification Scheme, certified institutions and their ECs are required to report to the NHMRC on their multicenter research activities.

As per AUS-21, the NHMRC assesses each institution’s interest in certification on a case-by-case basis. Certification respects institutional decisions about research governance matters, including whether research should be conducted at a given site. Before commencing steps to apply for certification, institutions should contact HREC.admin@nhmrc.gov.au.

For more information on the National Certification Scheme and the NHMRC’s continuous certification process, see AUS-21.

As stated in AUS-68, EC certification under the National Certification Scheme is required in order for ethics reviews of human research to be accepted under the National Mutual Acceptance (NMA) scheme. The NMA scheme facilitates single scientific and ethical review of clinical trials conducted in participating jurisdiction’s public health organizations. See the Scope of Review section for more information on NMA.

Role of Human Research Ethics Committees (HRECs)

Terms

Section 5 (Introduction and Chapters 5.1 and 5.8)

Part 1 (3) and Part 2 (5B, 5C)

Chapter 1 (3)

Last content review/update: November 27, 2024

Overview

Order1250-ZKM043 indicates that the Democratic Republic of the Congo’s (DRC) national ethics committee (EC), the National Committee of Health Ethics (Comité National d'Éthique de la Santé (CNES)), is responsible for promoting the creation of and accrediting institutional ECs across the country.

According to Order1250-ZKM043, the CNES coordinates the national network of institutional ECs, both public and private, throughout the country, and mobilizes funds for the functioning of the network of ECs.

Registration, Auditing, and Accreditation

No information is available on registration, auditing, and accreditation responsibilities by the CNES.

Title II (Article 4)

Submission Process

Last content review/update: September 30, 2025

Overview

In accordance with the G-CTHandbook, the G-TrialsSOP, and AUS-86, Australia requires the sponsor to obtain clinical trial authorization from the Therapeutic Goods Administration (TGA) for the supply of unapproved therapeutic goods for clinical trials for experimental purposes in humans. The sponsor can apply under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme.

Under either regulatory scheme, per the TGR, the G-CTHandbook, the G-TrialsSOP, and AUS-86, an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve the research protocol. The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC.

AUS-87 notes that some ECs and institutions may need the TGA’s acknowledgement before beginning their own approval processes. In these cases, the TGA will accept a CTN submission while the sponsor gets the required approvals from the EC and institution. However, it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial. Additionally, AUS-88 indicates that the sponsor can, either following TGA approval or in parallel with the TGA’s evaluation, contact their chosen EC to initiate ethics review of the CTA scheme trial proposal. However, trials can only commence once both TGA and EC approvals have been received.

According to AUS-40, all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site, and whether it has the capacity to conduct the research at that site. Per the G-TrialsSOP, the SSA and ethics review may occur in parallel. However, EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted. While there is no submission language requirement stated in the requirements, the official language of Australia is English.

Regulatory Submission

Per AUS-92, sponsors may request pre-submission meetings with the TGA. A pre-submission meeting can help both the applicant and the TGA to obtain a common understanding of the therapeutic good and what supporting documentation is needed to evaluate the application, as well as any issues to resolve before submitting applications. A meeting can also help the applicant and the TGA plan for the submission and manage both timeframes and resources.

AUS-88 indicates that all sponsors considering a CTA application submission are encouraged to request a pre-submission meeting. In the meeting, the TGA can clarify any questions the applicant has about existing studies or the proposed data package for a CTA application and give specialized advice on the CTA application process (including the best ways to submit the application and dossier).

See AUS-92 for more information on pre-submission meetings and AUS-17 for the applicable forms.

CTN Scheme

According to AUS-87 and AUS-30, CTN forms are submitted online through the TGA Business Services (TBS) webpage (AUS-36). The sponsor must have or obtain a TGA Client Identification Number.

As per AUS-49, to submit the online CTN form successfully through AUS-36, the sponsor must accept a declaration to assume responsibility for the trial. After accepting the declaration, a webpage will advise the sponsor that the CTN submission has been successful.

AUS-49 indicates that the sponsor may delegate duties and correspondence with the TGA to an authorized agent, which is able to create and submit a CTN on behalf of a sponsor. If an agent has submitted a CTN on the sponsor’s behalf, the sponsor will not have access to view or vary the CTN. Access is only granted to the agent.

See AUS-30 and AUS-49 for additional information on using and submitting the online form.

CTA Scheme

According to AUS-88 and AUS-89, the sponsor must submit the application form (AUS-56) and supporting data to the TGA as part of a CTA application, followed by a trial commencement notification form (AUS-57). Per AUS-89, all CTA forms should be submitted to the TGA via email at clinical.trials@health.gov.au (PDFs or Word files). If sending the forms by email (the recommended method), the sponsor is not required to send physical copies to the mailing addresses detailed in each form. Electronic/digital signatures can be used.

AUS-89 indicates that the sponsor should submit the supporting data in an electronic dossier (searchable PDFs). This should be sent via email to clinical.trials@health.gov.au. The sponsor is encouraged to contact the TGA for advice if the file is too large. See AUS-94 for more information on electronic dossiers and submissions.

As stated in AUS-89, the sponsor must send the notification form (AUS-57) to the TGA within 28 days of commencing supply of the unapproved therapeutic goods at each site.

Ethics Review Submission

AUS-46 indicates that the National Health and Medical Research Council (NHMRC) developed the Human Research Ethics Application (HREA) form (AUS-9) as a concise application to facilitate timely and efficient ethics review for research involving humans. The HREA assists researchers in considering the ethical principles of the G-NatlStmt in relation to their research and is accepted by institutions that participate in the National Mutual Acceptance (NMA) scheme, which facilitates single ethics review by multiple public health organizations for most human research.

According to the G-CTHandbook, trial sponsors and researchers should use the HREA unless advised otherwise. AUS-19 contains resources for using the HREA.

Per AUS-46, research proposals should be submitted to ECs associated with public health institutions in New South Wales, Queensland, South Australia, Australian Capital Territory, and Victoria, as well as Mater Research, via the Research GEMS system (AUS-55), the Ethical Review Manager (ERM) website (AUS-8), and/or the Research Ethics and Governance Information System (REGIS) (AUS-10), depending on which jurisdictions are involved. For research in the Northern Territory, Tasmania, or Western Australia, the EC should be contacted for their local submission requirements.

The G-CTHandbook further states that ECs have a high level of independence and are responsible for establishing their own processes for receiving research proposals.

Research Governance

According to the G-NatlStmt, institutions should publish (such as on their website) clear policies and procedures for institutional authorization of research. As noted in the G-CTHandbook, individual jurisdictions have specific requirements as a part of their SSA and authorization processes. South Australia sites use the online SSA form found in the Research GEMS system (AUS-55), while the ERM website (AUS-8) is used for SSA form submission for Mater Research, Queensland, and Victoria. New South Wales and the Australian Capital Territory use REGIS (AUS-10) for site governance applications.

Authorised Agent and Manual Submission

About this Handbook, Clinical Trials Involving Therapeutic Goods (Determine if the product is ‘unapproved’), The Australian Regulatory Environment, The CTN and CTA schemes, and Responsibilities under the CTN and CTA schemes (Role of Human Research Ethics Committees (HRECs))

Terms and SOP 05

Purpose, Scope and Limits of this Document, and Section 5 (Chapter 5.5)

Part 3 (12 and 12AA-12AD) and Schedule 5A

Last content review/update: November 27, 2024

Overview

Per D-ACOREP and the G-EthicalEval, the Democratic Republic of the Congo (DRC) requires clinical trial authorization from the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention). According to DRC-12, the sponsor, through the principal investigator (PI), obtains this authorization from ACOREP. In addition, the G-EthicalEval indicates that the PI is required to obtain approval from an ethics committee (EC) for any research proposal involving human subjects. The study protocol must be submitted to the EC for review concurrently with a request to ACOREP for study authorization and registration. Therefore, regulatory and ethics reviews are conducted in parallel. However, ACOREP approval is contingent upon EC approval.

Regulatory Submission

Per DRC-12, ACOREP’s delivery address is:

Ministère de la Santé Publique, Hygiène et Prévention
Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)
4ème niveau, immeubles 5 à sec, boulevard du 30 juin
Kinshasa I, B.P. 11998, République Démocratique du Congo

Ethics Review Submission

The G-EthicalEval indicates that the EC is responsible for establishing well-defined procedures for submitting an application for review, including requirements for language and assembly. These procedures, as well as any standard forms, must be public and available to applicants. In order to aid researchers, it is desirable that these procedures and forms be harmonized between all the active ECs in the country. Applicants should contact ECs individually for specific submission instructions.

According to a subject matter expert as of March 2019, research protocols and relevant materials to be submitted to the national EC, the National Committee of Health Ethics (Comité National d'Éthique de la Santé (CNES)), should be sent to:

National Committee of Health Ethics
Local 5, Immeuble PNMLS, 1er Niveau, Commune of Kasa-Vubu
Kinshasa, Democratic Republic of the Congo

Per a subject matter expert as of March 2019, CNES requires one (1) copy of the dossier, in addition to seven (7) copies of the protocol. Documents submitted to CNES must be in French.

Title II (Articles 3-4)

Guidelines 4, 5, and 13

Submission Content

Last content review/update: September 30, 2025

Regulatory Authority Requirements

Clinical Trial Notification (CTN) Scheme

As delineated in AUS-49, the following information must be submitted to the Therapeutic Goods Administration (TGA) through the online form on the TGA Business Services (TBS) webpage (AUS-36):

Sponsor name and address
Sponsor declaration
Notification fee (See Regulatory Fees section)
Organization-nominated contact’s name, phone number, and email
An optional alternative contact, which may be chosen from the contacts for the agent or sponsor organization submitting the CTN. An Australian contact number is required to be listed with either the primary sponsor contact or the alternate sponsor contact
Protocol number
Expected trial start and completion dates
Potential use of restricted goods
Study title and description, which must be a minimum of 250 characters (spaces included) and up to a maximum of 2,500 characters
“This Trial” check boxes indicating whether the trial involves the use of a medicine, a medical device, and/or a biological. For a medicine or biological, additional information must be provided, such as dosage form, route of administration, indication, and the good manufacturing practice (GMP) license/clearance number of a relevant exemption
Trial type
Whether the trial is a first in human trial
Whether the trial, in part or as a whole, has been halted/stopped/withdrawn or rejected in another country due to safety concerns
Total number of trial participants
Therapeutic area
Investigational product (IP) details
Whether it is a multi-center trial
Whether the trial is being conducted in other countries
Preceding trial details
Trial site details

See AUS-49 for detailed descriptions of each required item.

Clinical Trial Approval (CTA) Scheme

AUS-89 states that the CTA scheme includes two (2) forms – Part 1: the CTA application (AUS-56), which is submitted along with supporting data, and Part 2: Notification of the conduct of a trial under the CTA scheme (AUS-57).

Part 1: the CTA application (AUS-56) requires general information (sponsor name, data details, and sponsor declaration) and details on the medicine (active ingredient)/biological be submitted to the TGA.

Part 2: Notification of the conduct of a trial under the CTA scheme (AUS-57) requires trial sponsor information (name and client ID code), the IP or biological, and the notification type, as well as trial and trial site details (title of study and trial type). The form also requires signed certifications from the sponsor, the principal investigator (PI), the ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia), and the authority approving the conduct of the trial.

Ethics Committee Requirements

Per the G-CTHandbook, the EC and the institution are responsible for establishing what information should be provided in support of an application. The EC should request any additional information that it believes is necessary to undertake review of the proposed research. Unless advised otherwise, trial sponsors and researchers should use the Human Research Ethics Application (HREA) for submitting proposals for research involving humans to ECs.

AUS-46 indicates that the HREA assists researchers in considering the ethical principles of the G-NatlStmt in relation to their research. The G-NatlStmt requires that those who conduct and approve human research to consider:

How the research question/theme is identified or developed
The alignment between the research aims and methods
How the researchers and the participants will engage with one another
How the research data or information are to be collected, stored, and used
How the results or outcomes will be communicated
What will happen to the data and information after the project is completed

For more information on the HREA, see the Submission Process section.

The G-NatlStmt further specifies that in an application for review of their research, researchers should determine and state in plain language:

The research question or questions that the project is intended to explore
The potential benefit of exploring the question or questions including to whom that potential benefit is likely to flow, and whether that benefit is a contribution to knowledge or understanding, improved social or individual wellbeing, or the skill and expertise of researchers
The basis for that potential benefit as described in either relevant literature or a review of prior research unless, due to the novelty of the question, there is scarce literature or prior research
How the design and methods of the project will enable adequate exploration of the research questions and achieve the aims of the research
How the design of the project will maintain respect for the participants
Where relevant, that the research meets the requirements of any relevant regulations or guidelines authorized by law (such as those related to privacy and reporting requirements for disclosure of child abuse)
Whether or not the project has been reviewed by a formally constituted academic, scientific, or professional review process, and, if so, the outcome of that review

Research Governance

According to the G-NatlStmt, institutions should publish (such as on their website) clear policies and procedures for institutional authorization of research. See the Research GEMS system (AUS-55), the Ethical Review Manager (ERM) (AUS-8), and the Research Ethics and Governance Information System (REGIS) (AUS-10) websites for public health organization site-specific assessment (SSA) forms, which may differ between institutions and states or territories.

Clinical Protocol

The G-TrialsSOP indicates that where the investigator is responsible for the protocol development, the investigator must ensure the protocol follows the outline in the AU-ICH-GCP. Specific content of a protocol will vary depending on the research area, the level of risk to participants, the phase of the research and study design, and whether a medicinal product or a device or a therapeutic intervention is being researched. If satellite sites for a teletrial are involved in the study, no specific additional wording is required in the protocol, as relevant considerations will be addressed in other study-specific documents which may be annexed to the protocol.

The AU-ICH-GCP provides the following outline of the protocol:

General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
Background information
Objectives and purpose
Trial design
Selection, withdrawal, and treatment of participants
Assessment of efficacy
Assessment of safety
A description of the statistical methods to be used in the trial
Direct access to source data and documents
Quality control and quality assurance
Ethical considerations
Data handling and recordkeeping
Financing and insurance
Publication policy

Creating a New CTN Form

Responsibilities under the CTN and CTA schemes (Role of Human Research Ethics Committees (HRECs))

SOP 04

Sections 3 (Introduction and Chapter 3.1) and 5 (Chapter 5.1)

Last content review/update: November 27, 2024

Regulatory Authority Requirements

Per DRC-12, the following documents are required in a clinical trial application to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention):

Cover letter
Non-refundable application fee in accordance with ACOREP’s prescribed fee schedule
Application forms completed by ACOREP for the conduct of clinical trials and signed by authorized persons (principal investigator (PI) and authorized representative of the sponsor)
Clinical trial protocol
Proof of enrollment in a clinical trial registry
Investigator's brochure (IB)
Investigational product (IP) dossier
Certificate of good manufacturing practice (GMP)
Certificate of good clinical practice (GCP) and PI curriculum vitae (CV) for each site
Ethics committee (EC) approval
Insurance cover
Financial statement
Data and Safety Monitoring Board (DSMB) information and signed charter
Sponsor/PI contractual agreement
Informed consent and assent forms (if applicable)
Statistical analysis plan (SAP)
Material transfer agreement (if applicable)
Labeling materials

According to DRC-12, applications submitted to ACOREP should also comply with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3).

Ethics Committee Requirements

As specified in the G-EthicalEval, the PI must file the request for ethics review. The requirements for the submission must be clearly described in the EC’s application procedures. These requirements must include or specify at least the following:

Name(s) and address(es) of the secretary of the EC or the member(s) to whom the application is to be filed
Application form(s), made available by the EC, with a list of the documentation requested by the EC
Format of the application, clearly referring to the title, date, and version of the protocol
Documentation, the study protocol, the informed consent form (ICF), the IB, the PI's CV, and the certificate of insurance obtained
Language(s) in which the (essential) documents are to be filed
Number of copies to be filed
Application deadlines, based on review dates (15 days prior to the meeting)
Means by which the receipt of applications will be acknowledged, including communication regarding incomplete applications
Deadline for notification of the decision after examination (within 15 days)
Time limit in case the EC requests additional information or changes to the documents from the PI
Application examination fee, if applicable
Standard procedure for requesting amendments to the protocol

As per the G-EthicalEval, the following documentation must be submitted to the EC for the proposed research:

Application form dated and signed by the PI
Proposed research protocol (clearly identified and dated), describing objectives, data collection procedures, ethical considerations, and details of the research process
Supporting documents for information not detailed in the protocol
When the research involves a product under study (such as a drug or medical device), an adequate summary of all available safety, pharmacological, pharmaceutical, and toxicological data available on the product being evaluated, as well as a summary of the clinical experience gained to date on this product
Current CVs of the investigator(s), dated and signed
Planned means (including classified advertising) for the recruitment of potential research participants, if not described in the protocol
Description of the procedure to obtain the informed consent of the subjects according to the degree of instruction, if not sufficiently described in the protocol
Information pamphlet (clearly identified and dated) and other forms of information for potential participants, in the language(s) understood by them and, if necessary, in other languages
ICF (clearly identified and dated) in the language(s) understood by potential participants and, if necessary, in other languages
Statement regarding possible compensation for research subjects, for their participation (including reimbursement of expenses and access to medical care), if not sufficiently described in the protocol
Description of arrangements made, if any, for compensation for injury, if not sufficiently described in the protocol or certificate of insurance
A copy of the sponsor’s insurance policy, for the insurance coverage of the participants (if in a language other than French, a translation into French must also be provided)
Statement by the investigator committing to respect the ethical principles set out in the applicable guidelines, if not sufficiently described in the protocol
Any significant prior decisions made by other ECs or regulatory authorities regarding the research in question (whether in the same research site or another) and an indication of the change(s) made to the protocol in this regard (reasons for previous adverse decisions must be provided)
Any other information, such as the establishment of a Tolerance Data Monitoring Committee, also known as DSMB or Independent Committee

Clinical Protocol

According to the G-EthicalEval, the protocol should be prepared by the researcher(s) and contain a summary of the project, general information, a brief justification of the project, bibliographical references, and a documentary review. The protocol should describe the goals and objectives of the study, as well as its design and the methodology used. In addition, the protocol should address safety or tolerability considerations, monitoring, statistical data management and analysis, quality assurance, expected results and dissemination, and publication policy.

The G-EthicalEval further requires that the protocol provide guidance on the duration of the project and anticipated problems, project management and ethical considerations, the documents used to gather informed consent from subjects, the budget and funding agencies, and collaborators. Finally, the protocol should attach the CV of each researcher, listing all the projects in which the researcher is currently participating, and the percentage of time to be devoted to the project. Possible financing or insurance arrangements should also be specified in documents presented to the EC.

Additionally, DRC-3 requires the following protocol contents:

General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
Background information
Objectives and purpose
Trial design
Selection, withdrawal, and treatment of participants
Assessment of efficacy
Assessment of safety
A description of the statistical methods to be used in the trial
Direct access to source data and documents
Quality control and quality assurance
Ethical considerations
Data handling and recordkeeping
Publication policy

6

Guidelines 4, 5, 13, and Glossary

Timeline of Review

Last content review/update: September 30, 2025

Overview

In accordance with the G-CTHandbook, the G-TrialsSOP, and AUS-86, the Therapeutic Goods Administration (TGA) is responsible for authorizing the supply of unapproved therapeutic goods for clinical trials under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. According to the TGR, the G-CTHandbook, the G-TrialsSOP, and AUS-86, under either regulatory scheme, an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve research protocols. The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC.

AUS-87 notes that some ECs and institutions may need the TGA’s acknowledgement before beginning their own approval processes. In these cases, the TGA will accept a CTN submission while the sponsor gets the required approvals from the EC and institution. However, it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial. Additionally, AUS-88 indicates that the sponsor can, either following TGA approval or in parallel with the TGA’s evaluation, contact their chosen EC to initiate ethics review of the CTA scheme trial proposal. However, trials can only commence once both TGA and EC approvals have been received.

According to AUS-40, all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. Per the G-TrialsSOP, the SSA and ethics review may occur in parallel.

Regulatory Authority Approval

No timeline information is available for applications under the CTN or CTA schemes.

For information on how to check the status of a CTN, see AUS-49. Per AUS-88, stakeholders seeking more information on the CTA process are encouraged to contact the TGA at clinical.trials@health.gov.au.

Ethics Committee Approval

The EC review and approval process timeline varies by institution. However, according to the G-NatlStmt, the institutional EC must implement standard operating procedures that promote good ethics review, including timely consideration of applications.

Research Governance

The G-GovHndbk indicates that ethical review and site assessment, both components of research governance, are two (2) distinct processes relating to the ethical approval and institutional authorization of research involving humans. However, because evidence of EC approval is a component of the site assessment process, institutional authorization of a research project cannot be given until EC approval has been provided. The G-TrialsSOP further specifies that EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted.

While some parts of the research governance review must occur after the EC review, the G-GovHndbk recommends that as part of the national approach to single ethical review, institutions establish processes to facilitate parallel review. Project documentation processes related to site assessment may be considered as falling into these categories:

That which can be assessed independent of ethical review, such as evidence of research qualifications, supporting department approval forms, contracts, budgets, and insurance and indemnity documents
That which is subject to ethical review, but can be submitted prior to or in parallel with ethical review to enable independent assessment of other documentation, such as initial project application documents
That which can only be assessed subsequent to ethical approval, such as approved project application documents, fully signed regulatory documents, and a certificate of ethical approval

See the G-GovHndbk for additional National Health and Medical Research Council (NHMRC) guidance on best practices in the governance of multicenter human research as part of the national approach to single ethical review.

The NHMRC also developed the GPP-SiteAssess to help institutions streamline the research governance process and shorten clinical trial start-up times. See the GPP-SiteAssess for more information.

Report of the pilot of the Good Practice Process – Executive summary

Responsibilities under the CTN and CTA schemes (Role of Human Research Ethics Committees (HRECs))

Terms and SOP 05

Purpose, Scope and Limits of this Document and Section 5 (Chapter 5.1)

Part 3 (12 and 12AA-12AD) and Schedule 5A

Last content review/update: November 27, 2024

Overview

As per D-ACOREP, the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) is the regulatory authority responsible for regulating clinical trials in the Democratic Republic of the Congo (DRC).

The G-EthicalEval indicates that for research involving human subjects, the study protocol must be submitted to an ethics committee (EC) for review concurrently with a request to ACOREP for study authorization and registration. Therefore, regulatory and ethics reviews are conducted in parallel. However, the principal investigator (PI) must obtain the EC’s approval of the protocol before ACOREP may approve the trial.

Regulatory Authority Approval

No official timelines are specified in the available regulatory documentation.

Ethics Committee Approval

As per the G-EthicalEval, the EC must communicate its opinion on the protocol to the PI within 15 days of making a decision, and send a copy to ACOREP.

The G-EthicalEval further requires that ECs establish procedures for expedited review of research proposals. These procedures must address certain processes, including the nature of the requests, amendments, and other considerations acceptable for expedited review, as well as the quorum requirements for expedited review.

There is no stated expiration date for an EC approval in the regulatory resources referenced for the DRC.

Title II (Articles 3-4)

Guidelines 4, 5, 13, and 17

Initiation, Agreements & Registration

Last content review/update: September 30, 2025

Overview

In accordance with the G-TrialsSOP, the G-CTHandbook, and AUS-86, clinical trials involving unapproved therapeutic goods can only commence under the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme. According to the G-GovHndbk and the G-TrialsSOP, under either scheme, both institutional ethics committee (EC) (Human Research Ethics Committees (HRECs) in Australia) approval and research governance authorization are required before a research project can commence at a site.

AUS-87 notes that for trials conducted under the CTN scheme, it is the sponsor’s responsibility to have all relevant approvals in place. All approvals must be obtained before supplying the unapproved therapeutic good(s) in the clinical trial. After submission of the online CTN form with payment of the relevant fee is made to the TGA, the clinical trial is deemed to have been notified. Once this notification occurs, the sponsor may lawfully supply the unapproved therapeutic good(s) for the purposes of the trial. A CTN acknowledgement from the TGA is not required before the trial can begin recruiting.

AUS-89 indicates that the sponsor must send a trial commencement notification form (AUS-57) to the TGA within 28 days of commencing supply of the good(s) at each site for each new trial conducted under the CTA scheme, as well as additional sites in ongoing CTA trials.

Research Governance

Per the G-GovHndbk, research must be governed by the institution at all stages of a project. Ethical review and site assessment, both components of research governance, are two (2) distinct processes relating to the ethical approval and institutional authorization of research involving humans. According to AUS-40, all public and private health organizations must undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site, and whether it has the capacity to conduct the research at that site. Pursuant to the G-NatlStmt, authorization of research by the institution should consider, but not re-review, any issues raised during the ethics review of the research proposal, and each institution should have a process or processes for assessing the risk level of the research. These processes may involve seeking advice from relevant clinical or administrative staff, members of an EC, or a full meeting of the EC. All research should be developed, reviewed, authorized, conducted, and monitored in accordance with a research governance framework as described in an institution’s policy. For more information on institutional responsibilities, see the Site/Investigator Selection section.

The G-TrialsSOP states that in the case of a teletrial, the principal investigator (PI) must ensure that a robust site assessment is undertaken that fully quantifies the capabilities of each satellite site to inform the extent to which trial related activities can be delegated to the site. This may include a pre-commencement assessment before a specific trial is proposed so that the process of trial start up is expedited when a suitable trial is identified.

Per the G-TrialsSOP, prior to a study’s commencement, the PI must:

Submit the primary site's Clinical Trial Research Agreement (CTRA), EC approval, the SSA form, evidence of any relevant good clinical practice (GCP) training, and any other required documentation to the institution’s research governance officer (RGO)
Ensure all documentation and correspondence pertaining to the submission and approval processes is filed in the study master file (SMF) (see Appendix 8 of the G-TrialsSOP)
Ensure each satellite site completes and submits to their RGO a clinical trial sub-contract and an SSA form
Await site specific RGO authorization before any study related activity can occur at that site
Ensure the satellite site files all documentation in the satellite site study file (SSSF)

The G-TrialsSOP further states that prior to the initiation of a study, the investigator must also mutually agree with the sponsor on a scheduled date, time, and location for a study initiation visit at the participating site to ensure the site is prepared to commence the study. In the case of a teletrial, this may be at the primary site only, or could include (remotely) the satellite site(s) as determined by the study complexity by the sponsor/PI.

See the G-TrialsSOP for more information on site initiation requirements for primary and satellite sites.

The G-GovHndbk further indicates that in the national approach to single ethical review, site assessment and project authorization are the responsibility of each institution participating in a multicenter human research project while ethical review is provided by a single EC using certified ethical review processes. Each institution collaborating in a multicenter project utilizing the outcome of a single ethical review must individually authorize the commencement of research at their institution. To avoid unnecessary delays in research commencing at all collaborating centers and sites, each institution should consider relevant local matters prior to or in parallel with ethical review.

Clinical Trial Agreement

As delineated in the AU-ICH-GCP, the sponsor must sign an agreement between all involved parties, including investigators, institutions, contract research organizations, and others for documentation purposes. Further, the sponsor should obtain the investigator’s/institution's agreement to:

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

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

For the purposes of the G-TrialsSOP, the CTRA for the primary site and the sub-contract for each satellite site constitute part of a research governance application, which is submitted to the RGO. The CTRA covers matters such as confidentiality, intellectual property, ownership of data, insurance, and indemnity. The Medicines Australia CTRA (see AUS-38) is the recommended standard form.

Clinical Trial Registration

The G-NatlStmt requires that clinical trials be registered on a publicly accessible register complying with international standards before recruitment of the first participant. For information on these standards, see the World Health Organization (WHO)’s International Clinical Trials Registry Platform (ICTRP) (AUS-67). Per AUS-15, the Australian and New Zealand Clinical Trials Registry (ANZCTR) (AUS-12) recommends applying for registration at the same time as ethics submission.

The CTN and CTA schemes

1.17, 5.1.2, 5.6.3, and 8.2.6

Terms; SOPs 03, 05, and 06; and Appendix 8

Sections 3 (Chapter 3.1) and 5 (Chapter 5.1)

Last content review/update: November 27, 2024

Overview

As per D-ACOREP and the G-EthicalEval, the Democratic Republic of the Congo (DRC) requires clinical trial authorization from the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention). According to DRC-12, the sponsor, through the principal investigator (PI), obtains this authorization from ACOREP. As stated in the G-EthicalEval, for research proposals involving human participants, the PI must also obtain approval from an ethics committee (EC) before ACOREP can approve the trial. Per DRC-12, ACOREP accepts ethics review from any approved local EC.

According to DRC-12, an import license is required for the shipment of the investigational product (IP) to be used in the trial. The sponsor may apply for IP import approval through ACOREP’s Digital Platform (DRC-13). (See the Manufacturing & Import section for additional information).

Clinical Trial Agreement

The G-EthicalEval states that before submitting a clinical trial application, a memorandum of understanding must be developed between the sponsor or PI and the partner research institutions. The PI must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3).

As per DRC-3, the sponsor should obtain the investigator's/institution's agreement to:

Conduct the trial in compliance with GCP, with the applicable regulatory requirement(s), and with the approved protocol
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 these documents are no longer needed

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

Clinical Trial Registration

As per DRC-12, proof of enrollment in a clinical trial registry is a required element of a clinical trial application to ACOREP.

5.6

Title II (Articles 3-4)

Guidelines 4 and 5

Safety Reporting

Last content review/update: September 30, 2025

Safety Reporting Definitions

According to the G-SftyRpt, the following definitions provide a basis for a common understanding of Australia’s safety reporting requirements:

Adverse Event (AE) – Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have to have a causal relationship with this treatment
Adverse Reaction (AR) – Any untoward and unintended response to an investigational medicinal product related to any dose administered
Unexpected Adverse Reaction (UAR) – An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator's brochure (IB) for an unapproved investigational medicinal product)
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) – Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect
Suspected Unexpected Serious Adverse Reaction (SUSAR) – An adverse reaction that is both serious and unexpected
Significant Safety Issue (SSI) – A safety issue that could adversely affect the safety of participants or materially impact the continued ethical acceptability or conduct of the trial
Urgent Safety Measure (USM) – A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety (Note: This type of SSI can be instigated by either the investigator or sponsor and can be implemented before seeking approval from ethics committees (ECs) or institutions)

Safety Reporting Requirements

Investigator Responsibilities

As specified in the G-SftyRpt, the investigator is responsible for recording and assessing all AEs that occur at the site. The investigator is also required to inform the sponsor of all SAEs, and all USMs instigated by the site, within 24 hours of becoming aware of the event. All safety critical events must be reported to the sponsor, and for reported deaths, the investigator should supply the sponsor with any additional requested information. Further, the investigator must report to the institution all SSIs and SUSARs arising from the local site within 72 hours of becoming aware of the event.

However, the G-TrialsSOP states that the investigator must also report any SUSARs to the sponsor within 24 hours of becoming aware of the event, and USMs instigated by the investigator or site must be reported to the sponsor within 72 hours. Furthermore, the investigator must report all other significant issues to the sponsor within 15 days of instigating or becoming aware of the event. The investigator must notify the sponsor promptly regarding any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. The investigator must also be available to meet with the sponsor to discuss study progress, issues, and safety.

The G-TrialsSOP requires that within 72 hours of instigating or becoming aware of the event, the investigator must notify the institution of:

USMs
SUSARs arising from the local site
Any information received from the sponsor that may be new and have an impact on the continued ethical acceptability of the trial or may indicate the need for amendments to the trial protocol, including monitoring of safety

The G-TrialsSOP indicates that for satellite site(s) in teletrials, staff must report safety issues directly to the sponsor as per the timelines specified in the clinical trial protocol and the safety monitoring plan or similar document, in the same way as the primary site. Certified copies of the relevant safety reports/documentation generated at the satellite site must be sent to the primary site for filing in a study master file.

According to the G-TrialsSOP, the principal investigator (PI) must ensure that study staff, including those at teletrial satellite sites, are trained in the protocol, investigator’s brochure (IB), study procedures, and AE/SAE reporting. The PI must also ensure that a system for safety reporting duties is in place for all study staff. For more information on investigator responsibilities related to standard operating procedures (SOPs), see the G-TrialsSOP.

Sponsor Responsibilities

As delineated in the G-SafetyDataMgt, the G-SftyRpt, and the G-CTHandbook, the sponsor is required to expedite reporting of SUSARs to the Therapeutic Goods Administration (TGA).

The G-SafetyDataMgt indicates that other situations requiring expedited reporting may include information that might materially influence the benefit-risk assessment of an investigational product, or that would be sufficient to consider changes in the administration or conduct of a clinical trial.

According to the G-SftyRpt and the G-TrialsSOP, expedited reporting requires the sponsor to file reports to the TGA in the following specified timelines:

For an Australian SUSAR that is fatal or life-threatening, immediately, but no later than seven (7) calendar days, with any follow-up information within eight (8) calendar days
For all other Australian SUSARs, no later than 15 calendar days after becoming aware of the case

The G-SftyRpt and the G-TrialsSOP further indicate that the TGA, the EC, and investigators must also be notified of all SSIs that adversely affect the safety of participants, or materially impact the continued ethical acceptability or conduct of the trial. SSIs that meet the definition of a USM should be reported within 72 hours, and all other SSIs should be reported within 15 calendar days of the sponsor being made aware of the issue. It is strongly recommended that the sponsor contact the TGA within 24 hours of a USM being taken, and if initial contact is by telephone, it should be followed up with a written notification provided by e-mail within 72 hours. See AUS-53 for additional information on SSIs and USMs.

Per the G-SftyRpt, submitting individual reports of AEs, SAEs, and SUSARs to ECs, institutions, and investigators are no longer required. However, according to the G-TrialsSOP, the sponsor must provide the EC with an updated IB at least annually that supports trial oversight, depicts a clear picture of the evolving trial safety profile, and provides evidence that the sponsor is conducting its safety monitoring appropriately.

The G-CTHandbook and the G-SftyRpt further require the sponsor to maintain records of all other single case AEs and submit them to the TGA upon request. The G-CTHandbook indicates that the TGA does not require sponsors to submit individual SUSARs from outside Australia. Sponsors should continually monitor the safety of their clinical program and advise the TGA of any SSIs that arise from their analysis of overseas reports, or of any action that has been taken by another country’s regulatory agency. Investigators and ECs should also be informed of this information, and sponsors must be able to provide the TGA with the clinical details of any individual overseas AE reports if requested.

According to the G-TrialsSOP, the sponsor’s plans for safety data monitoring should be documented in a safety monitoring plan or similar document and be given to the PI prior to commencement of the clinical trial. The plan must be continually reviewed and updated during the trial, as real-time assessments of safety data are performed, and outcomes are made available.

Other Safety Reports

The G-SftyRpt delineates that the sponsor must provide the EC with an annual safety report including a clear summary of the evolving trial safety profile. The annual safety report should generally include:

A brief description and analysis of new and relevant findings
For investigational products (IPs) not on the Australian Register of Therapeutic Goods (ARTG) (AUS-22), a brief analysis of the safety profile of the IP and its implications for participants
A brief discussion of the implications of the safety data to the trial’s risk-benefit ratio
A description of any measures taken or proposed to minimize risks

A Development Safety Update Report (DSUR) or other similar document may also serve as the annual safety report. See the G-SftyRpt for more information.

Form Completion & Delivery Requirements

As per the G-CTHandbook, all SUSARs from Australian sites must be reported to the TGA using one (1) of three (3) formats:

The Electronic Data Interchange (EDI) functionality, which allows sponsors to submit AE reports directly from their system to the TGA (more information can be found at AUS-26)
The online reporting form, which can be accessed from AUS-51
The CIOMS Form I (AUS-4) or the TGA’s Blue Card Adverse Reaction Reporting Form (AUS-3)

Per AUS-3, the Blue Card form may be emailed to adr.reports@tga.gov.au or mailed to Pharmacovigilance and Special Access Branch, PO Box 100, Woden ACT 2606. More information about reporting to the TGA may be found on the Adverse Event Management System (AEMS) (AUS-7).

See AUS-37 for the SSI/USM reporting form, which should be submitted to clinical.trials@health.gov.au.

Introduction, Definitions and Terminology Associated with Clinical Safety Experience, Standards for Expedited Reporting, and Attachment 1

Summary of Main Changes to Reporting Requirements and Part 1 - Investigational Medicinal Product (IMP) Trials (C. An Overview of Safety Monitoring and Reporting Responsibilities)

Safety reporting to TGA for CTN and CTA trials

SOPs 02, 05, and 12

Last content review/update: November 27, 2024

Safety Reporting Definitions

As delineated in the G-PV, the following definitions provide a basis for a common understanding of the Democratic Republic of the Congo’s (DRC) safety reporting requirements:

Adverse Event (AE) – Any medical event occurring after the administration of a drug to a patient or subject of a clinical trial, without necessarily being caused by that drug. This includes any harmful and unwanted reaction such as a clinical or paraclinical sign or symptom, or a disease associated with taking a drug
Adverse Drug Reaction (ADR) – Any response to the administration of a drug that is harmful and undesirable. An ADR may result from the use of a drug at therapeutic doses, overdose, misuse, or medication error
Serious Adverse Event (SAE) – Any adverse reaction that causes death, is life-threatening, requires hospitalization or prolongation of hospitalization, leads to significant or persistent disability, or causes congenital malformation
Unexpected Adverse Event (UAE) – Any adverse event that does not match the known information on the drug in nature, severity, or outcome

According to the G-PV, the requirements in the G-PV are based on the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). The G-EthicalEval further indicates that before the start of the trial, the principal investigator (PI) must ensure adequate safety reporting procedures in accordance with DRC-3 and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10).

Order1250-SP013 states that the DRC’s National System of Pharmacovigilance, implemented by the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention), aims to identify as early as possible all of the adverse effects of health products, especially those that are serious and unexpected. The National System of Pharmacovigilance includes the National Pharmacovigilance Center, which is responsible for collecting information from manufacturers, health professionals, and other individuals on the adverse effects of health products; establishing accountability; and assessing the relative risk.

Safety Reporting Requirements

The G-PV indicates that it is mandatory to report any AE, even when it is the result of abuse or misuse. All providers are required to systematically report AEs.

According to G-PV, all AEs that are both serious and unexpected must be reported through the expedited notification process. Any serious and unexpected AE that is fatal or life-threatening, including those occurring during a clinical trial, should be notified to the National Pharmacovigilance Center as soon as the notifier becomes aware of it, within seven (7) calendar days. Updated information may be provided within an additional period not exceeding 15 calendar days. All other serious and unexpected AEs should be reported immediately, but no later than 15 calendar days after becoming aware of them. All other AEs must be reported within 90 calendar days.

In addition, according to DRC-12, SAEs must be reported to the national ethics committee (EC), the National Committee of Health Ethics (Comité National d’Éthique de la Santé (CNES)), or to the EC that approved the study.

Form Completion & Delivery Requirements

As per the G-PV, all AEs must be reported on a form (See Annex I of G-PV) and submitted in a sealed envelope or via internet to the National Pharmacovigilance Center:

Clinical Pharmacology Unit
Faculty of Medicine and Pharmaceutical Sciences
University of Kinshasa
Tel: 0998110172 / 0813261360 / 0993547926 / 0815171991 / 0815171766
Email: cnpvrdc@yahoo.fr and pharmacoclinique@unikin.ac.cd

5.16-5.17

Guideline 35

Introduction, I (I.1), III (III.2 and III.5), and Annex I

Chapter I (Article 2), Chapter III (Article 6), and Chapter VII (Article 18)

Progress Reporting

Last content review/update: September 30, 2025

Interim and Annual Progress Reports

As per the AU-ICH-GCP, the G-NatlStmt, and the G-TrialsSOP, the investigator(s) is responsible for submitting progress reports to the ethics committee (EC) (known as Human Research Ethics Committee in Australia) annually, or more frequently if requested. The AU-ICH-GCP and the G-TrialsSOP state that if there are significant changes in trial conduct or safety, the investigator should submit a written report to the sponsor, the EC, and where applicable, the institution. The G-NatlStmt indicates that at regular periods (reflecting the degree of risk, and at least annually), researchers should provide reports to the relevant EC(s) and institution(s), including information on:

Progress to date
The security of project-related data and information
Compliance with the approved proposal
Compliance with any conditions of approval

According to the G-NatlStmt, progress report forms should be designed to collect information that can provide meaningful assistance to reviewers in determining whether continuation of ethics approval is warranted. See the G-NatlStmt for more details.

Final Report

AUS-88 indicates that for trials conducted under the Clinical Trial Approval (CTA) scheme, the CTA clinical trial completion advice form (AUS-58) is used to notify the Therapeutic Goods Administration (TGA) after the trial has been completed at all sites. There is no fee for this notification. AUS-58 indicates that upon completion, the form may be emailed to the TGA at clinical.trials@tga.gov.au (preferred) or faxed to 02 6232 8112.

Per AUS-49, for trials conducted under the Clinical Trial Notification (CTN) scheme, a completion advice should be submitted through the TGA Business Services (TBS) webpage (AUS-36). The completion advice must include the date the trial was completed at all Australian sites, as well as the completion reason. AUS-87 further notes that there is no fee to submit a CTN completion. See AUS-49 for additional information on the completion advice.

The AU-ICH-GCP and the G-TrialsSOP indicate that the investigator should provide the EC with a final clinical study report. As per the G-TrialsSOP, the investigator must also notify the research governance officer that the trial has been terminated/closed. At the completion of the project, a report with the same information as described above for progress reports (per G-NatlStmt) must also be provided to the relevant EC(s) and institution(s), but it should include information on the outcome of the completed research.

Additionally, the TGA has adopted the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s Topic E 3: Structure and Content of Clinical Study Reports (AUS-81). For more information, see AUS-81.

Submitting a Completion Advice

4

SOP 05

Section 5 (Chapter 5.4)

Last content review/update: November 27, 2024

Interim and Annual Progress Reports

The G-EthicalEval also indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3).

DRC-3 notes that the investigator should submit written summaries of the trial status to the institutional ethics committee (EC) annually, or more frequently, if requested by the EC. The investigator should also promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

As per the G-EthicalEval, the EC must establish a procedure for monitoring the progress of all research that has been approved, from the date the decision was made to the end of the research. The follow-up intervals should be determined by the nature of the study and other events, although each protocol should be monitored at least once a year during the recruitment period.

Final Report

According to the G-EthicalEval, the PI must notify the EC of the closure of a study, and the EC should receive a copy of the final summary or final report of the research.

The G-EthicalEval further requires that community leaders receive an adapted report specifically for their understanding, with the relevant information. The results of the clinical trial should be shared with the participants based on the context and budgetary constraints.

4.10 and 4.13

Guidelines 20, 35, and 36

Definition of Sponsor

Last content review/update: September 30, 2025

As per the AU-ICH-GCP and the G-TrialsSOP, a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

In accordance with the AU-ICH-GCP, Australia permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO). Any trial-related duties and functions transferred to a CRO should be specified in a written agreement, and the sponsor should ensure oversight of such transferred responsibilities. Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor. The sponsor retains overall responsibility for the trial data’s quality and integrity, as well as the conduct of the trial. As stated in the G-TrialsSOP, the sponsor is also responsible for ensuring that appropriate approvals are obtained prior to the commencement of the clinical trial, that conditions of any approvals are adhered to during the course of the clinical trial, and that the ethics principles of research merit and integrity, justice, beneficence, and respect are applied to the conduct of clinical trials.

According to the G-CTHandbook, if the investigator initiates and organizes the trial, the role of trial sponsor is assumed. If another party (such as a pharmaceutical company) provides the IP or other support for an investigator-led trial, that party is not required to assume the sponsor role.

As per the G-CTHandbook and the G-TrialsSOP, a sponsor must be an Australian entity.

Determine if the product is ‘unapproved’ and Role of trial sponsors

1.53 and 5.2

Terms

Last content review/update: November 27, 2024

As per the G-EthicalEval, the sponsor is defined as the person, company, institute, or organization responsible for launching, managing, and/or financing a clinical trial, as well as legally responsible for the trial. In non-commercial research, it is often the case that the sponsor and the funding agency are different entities. In this case, the legal responsibility rests with the sponsor.

The G-EthicalEval indicates that for biomedical research on humans, the sponsor is the person who initiates, manages, and verifies the funding of the research.

The G-EthicalEval also indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 specifies that a sponsor-investigator is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a participant. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

DRC-3 also notes that a sponsor may transfer any or all trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

According to the G-EthicalEval, a sponsor may be domestic or foreign.

1.53, 1.54, 5.1, and 5.2

Guideline 35 and Glossary

Site/Investigator Selection

Last content review/update: September 30, 2025

Overview

As set forth in the AU-ICH-GCP, the sponsor should select the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. Prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure.

According to the G-TrialsSOP, the principal investigator (PI) must ensure that all required staff who assist with the clinical trial are informed about and trained on the protocol, any investigational product (IP), and their research-related duties and functions. This can be in the form of an initiation meeting held by any communication means, including face-to-face, videoconference, telehealth, etc. The PI must also have sufficient time to properly conduct and complete the research within the specified period, as well as an adequate number of qualified staff and adequate facilities for the foreseen duration of the research. When a teletrial is being conducted, the PI, who is always at the primary site and never at the satellite site, remains responsible for the trial across the cluster. For more information on PI site staff training and qualification requirements, see the G-TrialsSOP.

See AUS-64 for additional clinical trial and researcher resources.

Research Governance

The G-NatlStmt indicates that institutions must ensure that any human research for which they are responsible is designed, reviewed, approved, authorized, conducted, and monitored in accordance with the G-CodeConduct and the G-NatlStmt, along with any policies that they have developed that form part of their research governance framework. Each institution should be satisfied that the human research for which it is responsible meets both relevant ethical standards and scholarly or scientific standards, and ensure that those conducting the research (i) are either adequately experienced and qualified, or supervised; (ii) understand the need to assess risks to their own safety and that of participants; and (iii) are aware they are free to withdraw from research on conscientious grounds. Institutions should publish (such as on their website) clear policies and procedures for ethics review and approval and institutional authorization of research. They may establish their own processes for ethics review of research or use the review processes of another institution or external ethics review body.

Per AUS-63, the Australian Commission on Safety and Quality in Health Care developed the National Clinical Trials Governance Framework (AUS-63), which embeds clinical trials into routine health service provisions and strengthens the clinical and corporate governance arrangements for parties that deliver clinical trials. All jurisdictions have agreed to implement the framework in health service organizations, meaning the organizations will be assessed concurrently for clinical and corporate services and clinical trial service provisions. The framework describes the systems and processes that should be in place to implement an effective governance system considering local needs, values, and the context in which services are provided. For more information about implementation timing and assessments under the National Safety and Quality Health Service (NSQHS) standards, see AUS-63.

Foreign Sponsor Responsibilities

As per the G-CTHandbook and the G-TrialsSOP, a sponsor must be an Australian entity.

Data Safety Monitoring Boards

G-DSMB indicates that the sponsor may establish a Data Safety Monitoring Board (DSMB) (also referred to as Data Monitoring Committees (DMCs)) to review accumulating trial data in order to monitor the progress of a trial. The role of a DSMB is to provide advice on safety and/or trial conduct issues by making recommendations to the sponsor or trial steering committee on whether to continue, modify, or stop a trial. Per the AU-ICH-GCP, the DSMB should have written standard operating procedures (SOPs) and maintain written records of all its meetings.

According to the G-TrialsSOP, the sponsor may utilize a DSMB or independent individuals (e.g., a medical monitor) to:

Review accruing trial safety data in either an unblinded or blinded manner to assess treatment exposure
Access, assess, and review emerging efficacy data for the trial
Assess the balance of risks and benefits within the trial
Document the outcome of these reviews

Additionally, the Therapeutic Goods Administration (TGA) has adopted the European Medicines Agency (EMA)’s Guideline on Data Monitoring Committees (AUS-78), which discusses the key issues involved when sponsors include DSMBs as part of their trial management. For more information, see AUS-78.

Multicenter Studies

As delineated in the AU-ICH-GCP, in the event of a multicenter trial, the sponsor must ensure that:

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

As noted in the G-TeletrialPrncpls, Australian jurisdictions agree that “traditionally” multicenter clinical trials assume one (1) PI per geographic site, differing from teletrials. However, for the purposes of teletrials, multicenter trials may include some sites that have satellite sites supervised under teletrial guidance, including the Clinical Oncology Society of Australia (COSA)’s Australasian Tele-trial Model (AUS-2), the G-TeletrialPrncpls, and the G-TrialsSOP. Sponsor responsibilities in teletrials, as described in the G-TrialsSOP, are discussed throughout the Australia profile alongside other clinical trial regulations and guidance. See each section of the Sponsorship topic for additional applicable information.

National Clinical Trials Governance Framework and User Guide

What is a DSMB and what is its role?

Role of trial sponsors

5

Introduction, Terms, SOP 03, and SOP 12

Section 5 (Chapter 5.1)

Last content review/update: November 27, 2024

Overview

According to the G-EthicalEval, the principal investigator (PI) must be a qualified and experienced person in the relevant field of research, with an understanding of the concepts and research activities, the drug, its toxicity, and its safety. The PI reports to the sponsor, as well as to the regulatory authorities and the ethics committees (ECs).

Per the G-EthicalEval, before a trial begins, the PI must:

Be based in the Democratic Republic of the Congo (DRC), with some exceptions
Ensure that the approval of a recognized EC and regulatory authority are obtained, and that the information package developed by the sponsor regarding clinical trials has been read and accepted
Have a good knowledge of the protocol, related documents, and regulatory requirements of the regulatory authority or other regulatory body
Have read, understood, and agreed to work in accordance with the protocol, the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), or other applicable legal and regulatory documents
Use the investigational product (IP) only for the purpose of the study as described in the protocol
Take responsibility for the IP
Document the sequence of events to be followed in the conduct of the clinical trial, including the timeline, roles, and responsibilities
Ensure the availability of all necessary infrastructure, equipment, and finances for the conduct of the test or study
Develop any appropriate mechanism to obtain informed consent from the participant
Accept the involvement of the instructors to review and verify the quality control procedures and the conduct of the data
Accept the possibility of an audit and/or inspection by an independent auditor engaged by the sponsor, the regulator, or the EC
Obtain the right to publish (it is unethical for the sponsor to reserve the right to publish the research data)
Ensure adequate safety reporting procedures, etc. (see DRC-3 and DRC-10)

As per DRC-3, the sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources to properly conduct the trial for which the investigator is selected. If the organization of a coordinating committee and/or the selection of coordinating investigator(s) are to be utilized in multicenter trials, their organization and/or selection are the sponsor's responsibility. Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date investigator's brochure, and the sponsor should provide sufficient time for the investigator/institution to review the protocol and the information provided.

Foreign Sponsor Responsibilities

The G-EthicalEval requires that if a sponsor is a foreign person or entity, the sponsor must work closely with the PI(s) from the partner institution(s) with which the sponsor has signed a memorandum of understanding. Each PI, who must be based in the DRC, in turn works with one (1) or more local investigators at their site.

Data and Safety Monitoring Board

The G-EthicalEval indicates that, as appropriate, the EC should evaluate the adequacy of the arrangements made for monitoring and auditing research, including setting up a Data and Safety Monitoring Board (DSMB). Any information regarding the establishment of a DSMB should also be included in the documentation submitted to the EC in the clinical trial application packet. Per DRC-12, any DSMB information must also be included in the clinical trial application to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention).

DRC-3 notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Multicenter Studies

As delineated in DRC-3, in the event of a multicenter clinical trial, the sponsor must ensure that:

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and given EC approval
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 among investigators is facilitated

The G-EthicalEval also states that a coordinating investigator should be appointed to coordinate activities of PIs at each site of a multicenter trial.

1.25, 4, 5.5, 5.6, and 5.23

Guidelines 13, 16, and 35

Insurance & Compensation

Last content review/update: September 30, 2025

Insurance

The AU-ICH-GCP and the G-NatlStmt state that the sponsor should provide insurance in accordance with applicable regulatory requirements. In addition, according to the G-NatlStmt, institutions must ensure that sponsors have insurance arrangements in accordance with applicable regulatory requirements. The federal documents cited here do not explicitly require insurance.

Per the G-GovHndbk, the institution and investigator are responsible for managing risks of any proposed research, including providing appropriate insurance coverage.

Compensation

Injury or Death

According to the G-NatlStmt, institutions must ensure that sponsors have indemnity and compensation arrangements in accordance with applicable regulatory requirements, and that arrangements are in place to compensate trial participants for harm resulting from negligence in research. The AU-ICH-GCP further indicates that the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries. The federal documents cited here do not explicitly require indemnity.

The G-TrialsSOP states that if the investigator is notified or becomes aware that a trial participant intends to make a claim against the institution or sponsor for injuries arising as a result of participating in a clinical trial undertaken at the institution (or any of the satellite sites under supervision by the institution in a teletrial), the investigator must promptly notify the following parties in writing that such an action is intended:

The institution’s authority
The coordinating principal investigator (CPI)/principal investigator (PI)/associate investigator, as relevant
The sponsor

In addition, if the institution is notified or becomes aware that a trial participant intends to make a claim for compensation against the institution or sponsor for injuries arising as a result of participating in a clinical trial undertaken at the institution (or any of the satellite sites under supervision by the institution in a teletrial), the institution must promptly notify the institution’s insurer in writing that such an action is intended.

See AUS-39 for indemnity and injury compensation guidelines for commercially-sponsored trials.

Trial Participation

The G-NatlStmt states that it is generally appropriate to reimburse participants for the costs associated with taking part in research including travel, accommodations, and parking. Sometimes participants may also be paid for time involved. However, payment may not be disproportionate to the time involved, or include other incentives that encourage participants to take risks. Further, payment or reimbursement decisions should consider customs and practices of the community in which the trial will be conducted.

According to the G-ResearchPayment, any proposal for payment of participants should be considered by the ethics committee (EC) reviewing the research. The EC should be provided with a payment plan that includes:

A rationale for the proposed payments
The method and timing of any disbursements, including how they have been calculated, and
Information about how prospective participants will be advised of the provision of payment

Payment of participants is ethically appropriate if it is equitable and proportionate to the burden of the research, and does not:

Undermine a participant’s capacity to provide voluntary and informed consent
Unduly influence a participant to accept a risk or burden that is greater than they would otherwise accept in everyday living or to compromise their fundamental values
Unduly influence a participant to make false representations about or conceal information that is relevant to their eligibility for the research, their contribution to the research, or the risks related to participation

To minimize the likelihood of a payment acting as an undue influence, the G-ResearchPayment further indicates that payment of participants should generally be limited to reimbursement of documented expenses and remuneration for time and inconvenience. Payment may be offered as an incentive to participate in cases where the research offers little or no benefit to individuals or where the research requires the participation of target populations that are difficult to recruit. In these cases, adequate processes must be in place to promote valid consent. For more information and examples of payment models, see the G-ResearchPayment.

According to the AU-ICH-GCP, payments to a participant should be prorated and not wholly contingent on completion of the trial by the participant.

Post-Trial Access

Per the G-NatlStmt, researchers must make clear to the participant if there are any intended therapeutic benefits from the trial, and if the treatment will be available only through participation in the trial. In addition, researchers must make it clear to the participant whether they will have access to the treatment or information they received after completion of the trial.

Guidance Statements

IV

3, 4, 5, and 8

SOP 05

Sections 2 (Chapter 2.2), 3 (Chapter 3.1), and 5 (Chapter 5.1)

Last content review/update: November 27, 2024

Insurance

As per the G-EthicalEval, the sponsor is required to carry a valid insurance policy to cover research participants. A copy of the sponsor’s insurance policy must be submitted to the ethics committee (EC) as part of the application for ethics review of the proposed research. If the insurance policy is in a language other than French, a French translation must also be provided.

Per DRC-12, insurance cover documentation must also be included in the clinical trial application to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention).

Compensation

The G-EthicalEval indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 provides guidance for sponsors on providing compensation to research participants.

Injury or Death

The G-EthicalEval indicates that the clinical trial application packet submitted to the ethics committee (EC) must include a description of arrangements made, if any, for compensation for injury, if not sufficiently described in the protocol or certificate of insurance.

DRC-3 states that the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Trial Participation

As per the G-EthicalEval, the application packet submitted to the EC must also include a statement regarding possible compensation for research subjects for their participation (including reimbursement of expenses and access to medical care), if not sufficiently described in the protocol.

4.8 and 5.8

Guidelines 13 and 35

Risk & Quality Management

Last content review/update: September 30, 2025

Quality Assurance/Quality Control

As per the AU-ICH-GCP, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

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

The G-RBMgmtMntring provides further guidance on the application of risk-based trial processes, particularly as a reference to sponsors of non-commercial trials.

The AU-ICH-GCP further indicates that the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data generated, recorded, and reported in compliance with the protocol, the AU-ICH-GCP, and the applicable regulatory requirements. The sponsor is responsible for obtaining agreement from all involved parties to ensure direct access to all trial-related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. The sponsor should implement a system to manage quality throughout all stages of the trial process, and QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. Any agreements between the sponsor and investigator, or with any other parties involved in the clinical trial, should be written, either within the protocol or in a separate agreement.

As per AUS-74, the Therapeutic Goods Administration (TGA) has adopted certain guidelines released by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), and the United States Food & Drug Administration (FDA) regarding quality management and technical aspects of clinical trials. See each of these documents for additional details:

ICH Guideline E8 (R1) on General Considerations for Clinical Studies (AUS-76)
Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products (AUS-77)
Guideline on Clinical Trials in Small Populations (AUS-79)
ICH E11(R1) Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population (AUS-80)
Use of Electronic Health Record Data in Clinical Investigations - Guidance for Industry (AUS-82)
Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products - Guidance for Industry (AUS-83)
ICH Topic E 10 Choice of Control Group in Clinical Trials (AUS-84)
ICH Topic E 9 - Statistical Principles for Clinical Trials (AUS-85)

See AUS-74 for more information on, as well as a list of, the international scientific guidelines adopted by the TGA.

Responsible Research Conduct

The G-CodeConduct outlines principles, responsibilities, and expectations for institutions and researchers to facilitate responsible research practices. Australian institutions must establish and maintain good governance and management practices for responsible research conduct. In addition, researchers must comply with the relevant laws, regulations, disciplinary standards, ethics guidelines, and institutional policies related to responsible research conduct. Compliance with the G-CodeConduct is a requirement to receiving funding from the National Health and Medical Research Council (NHMRC) or the Australian Research Council (ARC).

The G-CodeBreaches describes the preferred model for institutions to use to investigate and manage potential code breaches, to determine any corrective actions, and when a finding of research misconduct may be made. The Australian Research Integrity Committee uses the G-CodeBreaches as a guide for reviewing how NHMRC- and ARC-funded institutions manage potential code breaches.

The G-RptBreachGCP requires the sponsor to notify the reviewing ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) within seven (7) days of confirming a serious breach of good clinical practice (GCP). A serious breach is defined as one that is likely to affect to a significant degree: the safety or rights of a trial participant or the reliability and robustness of the data generated in the trial. Sponsors should also develop documented processes for managing serious breaches. The G-TrialsSOP notes that although all deviations or breaches of the protocol must be reported by the investigator to the sponsor, only serious breaches must be reported to the EC. Serious breaches should also be reported by the principal investigator (PI) to their institution, as they may have an impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.

The supplementary guidance G-RptBreachGCP should be read alongside the G-CodeConduct and the G-CodeBreaches.

Monitoring Requirements

As part of its QA system, the AU-ICH-GCP notes that the sponsor should ensure the trial is monitored and audited. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, the AU-ICH-GCP, and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial. The sponsor should ensure that the auditors are qualified by training and experience, and the auditor’s qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with its own SOPs and that the auditor’s observations are documented.

Per the G-TrialsSOP, the PI must ensure audit/inspection readiness throughout the study, have oversight of any audit or inspection of the trial at both primary and satellite sites, and ensure any deficiencies identified through audit or inspection are actively managed to ensure continuous improvement.

The TGR further states that the sponsor must provide a written assurance to comply with any trial-related requests by an authorized TGA officer(s), which includes allowing inspection of clinical trial sites. The PI is required to comply with requests and answer any questions the authorized officer(s) may have. According to the G-GCP-Inspect, clinical trial sites that have been notified of a GCP inspection should prepare for the inspection by:

Ensuring their authorizing institution, trial sponsor, and clinical team are advised of the inspection (the G-GCP-Inspect notes that although the TGA does not require that the sponsor be informed, there is generally a requirement in the contract between the site and the sponsor to share this type of information)
Ensuring access for the inspectors to clinical trial records and source documents is arranged for the time of the inspection
Ensuring their IT processes allow them to grant view-only access to the inspectors

The G-GCP-Inspect adds that ECs and trial sponsors are not included in the scope of the TGA’s GCP inspection program. The site PI can invite other personnel, including the sponsor and institution/EC representative(s), to attend the inspection opening and closing meeting. See the Scope of Assessment section, the G-GCP-Inspect, and AUS-90 for more information on TGA inspections.

Premature Study Termination/Suspension

As per the G-CTHandbook, procedures following the TGA’s revocation of approval under the Clinical Trial Approval (CTA) scheme or a breach of the conditions of the Clinical Trial Notification (CTN) scheme would be determined on a case-by-case basis based on the impact on participants and their ongoing safety. The AU-ICH-GCP states that if a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigator(s), institution(s), the EC, and the TGA. The sponsor should provide the reason(s) for the termination or suspension. Additionally, as indicated in the G-CTHandbook, the sponsor must notify all sites in the case of a multicenter trial. A lead EC in a multicenter study will need to liaise with the sites and the sponsor when determining which, if any, are affected and the actions they need to apply.

According to the G-TrialsSOP, if a trial is prematurely terminated or suspended for any reason, the investigator must:

Promptly inform the sponsor, EC, research governance officer, associate investigator, any satellite site, and the TGA by providing a detailed written explanation of the premature termination or suspension
Promptly inform the trial participant and the participant’s primary care physician where the trial participant has consented, of the termination or suspension and, if applicable, of the investigational product (IP) and dose that was administered
Assure appropriate therapy and follow up for the participant’s continued care

As per the G-NatlStmt, if an institution or EC considers that suspension of research is necessary, the instruction to stop should come from the management of the institution. Where ethics approval for a research project is suspended:

The institution must ensure that the researcher promptly suspends the research and makes arrangements to meet the needs of participants, such as ensuring that appropriate counselling support or the provision of standard care continues
The research may not be resumed unless: (i) the research is modified to provide sufficient protection or participants or address the concerns that led to the suspension; or (ii) the researcher establishes to the satisfaction of the EC that continuation of the research will not compromise participants’ welfare; and (iii) the institution authorizes the continuation of the research

The G-NatlStmt further indicates that if ethics approval for a research project is withdrawn, the researcher must promptly halt the research, make arrangements to meet the needs of participants, and notify the institution that these steps have been taken.

Preamble, Responsibilities of institutions, and Responsibilities of researchers

Introduction

Responsibilities under the CTN and CTA schemes

5

SOPs 02, 05, and 13

Section 5 (Chapter 5.4)

About the Good Clinical Practice (GCP) Inspection Program and Preparing for an Inspection

Background and Scope

Part 3 (12AB and 12AC)

Last content review/update: November 27, 2024

Quality Assurance/Quality Control

The G-EthicalEval indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 provides guidance for sponsors on clinical trial quality management.

Per DRC-3, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

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

Monitoring Requirements

Per DRC-3, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Premature Study Termination/Suspension

The G-EthicalEval indicates that in the event of suspension or premature termination of a trial, the PI must inform the ethics committee (EC) of the reasons for the decision. A summary of the results up to that point must then be submitted to the EC.

According to DRC-3, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

5.0, 5.1, 5.2, 5.5, 5.18, 5.19, 5.21, and 6.10

Guidelines 20 and Glossary

Data & Records Management

Last content review/update: September 30, 2025

Electronic Data Processing System

When using electronic trial data handling systems, the sponsor must ensure and document that the electronic data processing system conforms to its established requirements for completeness, accuracy, reliability, and consistent intended performance, and that standard operating procedures (SOPs) are maintained for using these systems. Refer to the AU-ICH-GCP for additional information.

The Therapeutic Goods Administration (TGA) has adopted the United States Food & Drug Administration (FDA)’s Use of Electronic Health Record Data in Clinical Investigations - Guidance for Industry (AUS-82). For more information, see AUS-82.

Records Management

According to the G-CodeConduct and the G-DataInfoMgt, institutions must provide access to facilities for the safe and secure storage and management of research data, records, and primary materials.

The G-DataInfoMgt requires that institutional policy include guidance for managing research data and primary materials that addresses the following:

Ownership, stewardship, and control
Storage, retention, and disposal
Safety, security, and confidentiality
Access by interested parties

Furthermore, institutional policies on ownership of, and access to, databases and archives must require that:

Researchers are informed of relevant confidentiality agreements and restrictions on the use of research data
Computing systems are secure
Information technology personnel understand their responsibilities for network security and access control
Those holding primary material, including electronic material, understand their responsibilities for security and access

The G-CodeConduct and the G-DataInfoMgt further state that researchers must retain clear, accurate, secure, and complete records of all research including research data and primary materials. Additionally, the G-NatlStmt indicates that when multiple researchers are collaborating on the collection, storage, and/or analysis of data or information, they should agree to the arrangements for custodianship, storage, retention, and destruction of those materials, as well as the rights of access, rights to analyze/use and re-use the data or information, and the right to produce research outputs based upon them.

According to the G-TrialsSOP, the investigator must maintain adequate source documents and trial records, including all key observations on each of the trial participants. The investigator must also store all trial related documents in a study master file (SMF) and take measures to prevent accidental or premature destruction of these documents. In the case of a teletrial, the SMF is stored at the primary site, and the principal investigator (PI) must have control of all essential documents and records generated by the investigator(s), institution, and satellite site(s) before, during, and after the trial. The PI must also establish the maintenance rules of the SMF and relationship between the primary site’s SMF and any satellite site study files. For more information on the SMF, see the G-TrialsSOP.

As set forth in the annotated AU-ICH-GCP, the TGA requires that the sponsor retain records for 15 years following the completion of a clinical trial. However, product liability is the overriding consideration, and the sponsor should be able to produce records at any time, including possibly beyond the life of a product, in the event of an adverse event claim. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

The TGA has adopted the European Medicines Agency (EMA)’s Guideline on the Content, Management and Archiving of the Clinical Master File (Paper and/or Electronic) (AUS-75). For more information on the clinical trial master file, see AUS-75.

Data Management Plan

According to the G-NatlStmt and the G-DataInfoMgt, researchers should create a data management plan, which should be developed as early as possible in the research process and should include details regarding:

Physical, network, system security, and any other technological security measures
Policies and procedures
Contractual and licensing arrangements and confidentiality agreements
Training for members of the project team and others, as appropriate
The form in which the data or information will be stored
The purposes for which the data or information will be used and/or disclosed
The conditions under which access to the data or information may be granted to others
What information from the data management plan, if any, needs to be communicated to potential participants

The G-NatlStmt states that in the data management plan, researchers should also clarify whether they will seek extended or unspecified consent for future research, or permission from a review body to waive the requirement for consent. In addition, the security arrangements specified in the plan should be proportional to the risks of the research project and the sensitivity of the information.

In accordance with the G-NatlStmt, researchers must comply with all relevant legal and regulatory requirements that pertain to the data or information collected, used, or disclosed as well as the conditions of the consent provided by participants. Data, information, and biospecimens used in research should be disposed of in a manner that is safe and secure, consistent with the consent obtained and any legal requirements, and appropriate to the research design.

The G-NatlStmt indicates that in the absence of justifiable ethical reasons and to promote access to the benefits of research, researchers should collect and store data, or information generated by research projects, in such a way that they can be used in future research projects. A justification must be provided when a researcher believes there are valid reasons for not making data or information accessible. More details are provided in the G-NatlStmt.

In addition, for details related to secondary use and sharing of data or information, see the G-NatlStmt.

Preamble, Responsibilities of Institutions, and Responsibilities of Researchers

5

Responsibilities of Institutions and Responsibilities of Researchers

SOPs 07 and 08

Section 3 (Chapter 3.1)

Last content review/update: November 27, 2024

Electronic Data Processing System

The G-EthicalEval indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 provides guidance for sponsors on clinical trial data and records management.

As per DRC-3, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to DRC-3 for additional information.

Records Management

According to the G-EthicalEval, the research protocol should address monitoring, statistical data management and analysis, quality assurance, expected results and dissemination, and publication policy.

As set forth in DRC-3, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, DRC-3 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

1.65, 5.5, and 8

Guidelines 20 and Glossary

Personal Data Protection

Last content review/update: September 30, 2025

Responsible Parties

Per AUS-70, the PrivacyAct regulates how certain health service providing organizations collect and handle personal information, including health information. It also includes provisions that generally allow an individual to access information held about them.

According to the PrivacyAct, agencies and organizations as defined in the PrivacyAct must comply with the Act and the Australian Privacy Principles (APP), found in Schedule 1, and are referred to as APP entities.

Data Protection

Per the PrivacyAct’s APP, an APP entity must have a clearly expressed and up-to-date policy about the management of personal information by the entity. Individuals must have the option of not identifying themselves or of using a pseudonym, and an APP entity must not collect sensitive information about an individual unless the individual consents to the collection of the information.

The APP outline further requirements for the consideration of personal information privacy; the collection of personal information; dealing with personal information; the integrity of personal information; and access to, and correction of, personal information. For the full list of APP, see Schedule 1 of the PrivacyAct. Additionally, see the Office of the Australian Information Commissioner (OAIC)’s guidelines on the APP (G-APP) for more information.

Consent for Processing Personal Data

The PrivacyAct’s APP indicate that if an APP entity holds personal information about an individual that was collected for a particular purpose, the entity must not use or disclose the information for another purpose unless consent is obtained from the individual. There are limited exceptions to this requirement, which can be found in Schedule 1 of the PrivacyAct.

AUS-70 notes that in certain circumstances, the PrivacyAct permits the handling of health information and personal information for health and medical research purposes, where it is impracticable for researchers to obtain individuals' consent, recognizing: the need to protect health information from unexpected uses beyond individual healthcare, and the important role of health and medical research in advancing public health. To promote these ends, the OAIC approved the National Health and Medical Research Council (NHMRC)’s legally binding guidelines, G-PrivacyAct95 and G-PrivacyAct95A, which researchers must follow when handling health information for research purposes without individuals' consent. The guidelines also assist ethics committees (ECs) (known as the Human Research Ethics Committees in Australia) in deciding whether to approve research applications. The guidelines are:

G-PrivacyAct95, which sets out procedures that ECs and researchers must follow when personal information is disclosed from a federal agency for medical research purposes
G-PrivacyAct95A, which provides a framework for ECs to assess proposals to handle health information held by organizations for health research (without individuals' consent). It ensures that the public interest in the research activities substantially outweighs the public interest in the protection of privacy

See the PrivacyAct, the G-PrivacyAct95, and the G-PrivacyAct95A for more information.

Part II (6), Part III (15 and 16B), and Schedule 1

Last content review/update: November 27, 2024

Responsible Parties

As per the DigiCode, the data controller is a natural or legal person, public authority, agency, or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data. The representative of the data controller is a natural or legal person permanently established in the territory of the country, who replaces the data controller in fulfilling the obligations provided for in the DigiCode. Additionally, the data controller must appoint a data protection officer to ensure that any processing of personal data is not likely to infringe on the rights and freedoms of the data subjects. The data protection officer is responsible for ensuring, in an independent manner, the internal application of the provisions of the DigiCode, and for keeping a register of the processing carried out by the data controller.

Additionally, the DigiCode provides for the establishment of the Data Protection Authority (APD), which will be responsible for monitoring compliance with the DigiCode provisions related to the processing of public and personal data hosted in the Democratic Republic of Congo (DRC). As of November 2024, there is no information available on the establishment of the APD. See the DigiCode for more information on the APD.

Data Protection

As stated in the DigiCode, personal data must be treated confidentially and protected, in particular when the processing involves transmissions of data over a network. The personal data must be kept in a form that permits identification of the persons concerned for a period not exceeding that necessary to achieve the purposes for which they are collected or for which they are processed. Personal data may be kept for longer periods to the extent that they will be processed exclusively for archival purposes in the public interest, for scientific or historical research purposes, or for statistical purposes, provided that the appropriate technical and organizational measures are implemented to guarantee the rights and freedoms of the person concerned. The personal data collected must be reliable, adequate, relevant, accurate, complete, and not excessive. All appropriate measures must be taken to ensure that data that is inaccurate or incomplete, in relation to the purposes for which it was collected or for which it is subsequently processed, is erased or rectified.

According to the DigiCode, the processing of personal data is subject to a prior declaration to the APD. The declaration, which includes an undertaking that the processing meets the requirements of the DigiCode, is made by the data controller or their representative. Additionally, the processing of personal data relating to genetic and medical data, as well as scientific research in these areas, requires prior authorization from the APD before any implementation. The intended transfer of personal data to a third country also requires prior authorization. The request for authorization is submitted by the data controller or their representative. See the DigiCode for more information on declarations and authorizations.

The DigiCode indicates that the request for declaration or authorization may be sent to the APD electronically, by post, or by any other means where the receipt is acknowledged by the APD. The APD will make a decision within 30 days of receipt of the request for declaration or authorization. This period may be extended once by 30 days upon reasoned decision of the APD. If the declaration or authorization requested from the APD is not made within the prescribed period, the silence of the APD will be deemed to be acceptance. In the event of refusal by the APD, the data controller may appeal within 15 days of notification of the refusal decision.

The DigiCode states that the processing of personal data is carried out within the framework of respect for human dignity, privacy, and public freedoms. The processing of personal data, whatever its origin or form, must not infringe the rights of persons protected by the laws and regulations in force and it is, in all cases, prohibited to use this data to harm persons or their reputation. Additionally, the personal data must be processed in a manner that ensures appropriate security, including protection against unauthorized or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organizational measures.

See the DigiCode for more information on the responsibilities of the data controller and the data protection officer.

Consent for Processing Personal Data

The DigiCode indicates that the processing of personal data will be lawful only to the extent that the data subject has consented to the processing of their personal data or if the processing is necessary for the performance of a legal obligation to which the controller is subject. If the data subject is incapable of giving consent, consent is governed by the principle of common law.

Per the DigiCode, where processing is based on consent, the controller must be able to demonstrate that the data subject has given consent for the processing of their personal data. Where the data subject's consent is given in the context of a written statement which also concerns other matters, the request for consent must be completed in a form which clearly distinguishes it from these other matters, in a comprehensible and easily accessible manner, and formulated in clear and simple terms. The data subject has the right to withdraw consent at any time, by the same means used to give it. Withdrawal of consent will not affect the lawfulness of processing based on consent prior to its withdrawal. The data subject must be informed of this before giving consent. Withdrawal should be as simple as giving consent. When determining whether consent is freely given, the utmost regard should be given, among other things, to whether the performance of a contract (including the provision of a service) is subject to consent for personal data processing, but such processing is not necessary for the performance of that contract.

According to the DigiCode, the data subject may request from the controller:

Information allowing them to know and contest the processing of their personal data
Confirmation as to whether or not personal data concerning them are being processed, as well as information on the purposes of the processing; the categories of data to which it relates and the categories of recipients to whom the data is communicated; the recipients or categories of recipients to whom the personal data have been or will be communicated, where possible; and the existence of automated decision-making, including profiling, and, at least in those cases, meaningful information about the logic involved, as well as the significance and envisaged consequences of such processing for the data subject
The communication in intelligible form of personal data concerning them, as well as any available information as to the origin of such data
Where applicable, information relating to the transfers of personal data envisaged to a third party, after consultation with APD
Where possible, the envisaged period for which the personal data will be retained or, where this is not possible, the criteria used to determine that period
The existence of the right to request from the controller rectification or erasure of personal data, or restriction of processing of personal data concerning the data subject, or to object to such processing
The right to lodge a complaint with the competent authority
Any available information as to their source, where the personal data are not collected from the data subject

See the DigiCode for additional details on data subject rights.

Preliminary Book (Article 2), Book I (Articles 15-18), and Book III – Digital Content (Articles 187, 189-194, 196, 209-216, 222, and 262-270)

Documentation Requirements

Last content review/update: September 30, 2025

Obtaining Consent

In all Australian clinical trials, valid consent is required from each participant in accordance with the requirements set forth in the AU-ICH-GCP and the G-NatlStmt. According to the AU-ICH-GCP, if requirements specified in the G-NatlStmt appear to differ from those specified in the AU-ICH-GCP, the Therapeutic Goods Administration (TGA) recommends compliance with the G-NatlStmt.

As per the AU-ICH-GCP, the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (known as a Human Research Ethics Committee in Australia) and kept on file before the trial commences. (See the Required Elements section for details on what should be included in the form.)

According to the G-TrialsSOP, the principal investigator (PI) for any research project retains overall responsibility for ensuring a participant’s consent has been obtained in the correct manner prior to the participant’s entry into the project. This includes where consent is obtained from participants at satellite sites in a teletrial. The PI can delegate the duty for obtaining consent to a suitably qualified associate investigator at the PI’s discretion, but the PI remains responsible for any delegated activity. Furthermore, the investigator must ensure that institutional authorization is obtained, inclusive of approval by an appropriate EC, for all written information and any other media used to provide information to potential participants prior to their usage to obtain consent from any participant.

The AU-ICH-GCP states that the investigator must provide detailed research study information to the participant or legal representative/guardian. The ICF content should be as non-technical as practical and understandable to the participant or legal representative/guardian. The G-TrialsSOP further indicates that the ICF and relevant EC-approved participant information documents can be provided in person, by telehealth, or by telephone and email or weblink. If informed consent is obtained by telephone, this must be recorded on the ICF and in the participant’s health and medical record, and/or source document, stating (as an example): “The protocol was discussed with [participant’s name] via telephone on [DD/MM/YYYY].”

According to the G-TrialsSOP, e-consent may be the preferable option for teletrials, as consent signatures can be obtained contemporaneously at both primary and satellite sites. For more information on obtaining consent using telehealth, see the G-TrialsSOP.

As per the AU-ICH-GCP, the ICF content should be clearly presented orally, or in a written language that is easy to understand, and commensurate with the age and comprehension level of the research participant. The participant and legal representative/guardian should also be given adequate time to consider whether to participate. According to the G-NatlStmt, information should also be presented to potential participants in ways that help them make informed choices. To this end, the researcher should take into account cultural and language barriers, the need for accurate and reliable translation, the participant’s educational background, the participant’s age and maturity level, and whether there is a visual, hearing, or communication impairment. See AUS-65 for researcher guidance on how to talk to potential participants.

Furthermore, as delineated in the G-TrialsSOP, the PI or delegate must assess the potential participant’s understanding of what they are agreeing to, that they are aware of the purpose of the study, what will be involved, and any risks that may exist. The participants must demonstrate that they fully understand the implications of decisions that may be made within the course of the research.

Per the G-NatlStmt, where a potential participant lacks the capacity to consent, a person or appropriate statutory body exercising lawful authority for the potential participant should be provided with relevant information and decide whether the individual will participate. That decision must not be contrary to the individual’s best interests. Researchers should bear in mind that the capacity to consent may fluctuate, and even without that capacity, people may have some understanding of the research and the benefits and burdens of their participation. Additionally, within some communities, decisions about participation in research may involve not only individuals but also properly interested parties such as formally constituted bodies, institutions, families, or community elders. See the Emergencies, Vulnerable Populations, Children/Minors, Prisoners, and Mentally Impaired sections for additional information about these populations.

As per the AU-ICH-GCP, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or to appear to waive their legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representative(s) from liability for negligence. Per the G-NatlStmt, no person should be subject to coercion or pressure in deciding whether to participate in a trial.

The G-NatlStmt indicates that consent may be:

Specific – limited to the specific project under consideration
Extended – given for the use of data or tissue in future research projects that are: (i) an extension of, or closely related to, the original project; or (ii) in the same general area of research (for example, genealogical, ethnographical, epidemiological, or chronic illness research)
Unspecified – given for the use of data or tissue in any future research

The G-NatlStmt further states that when unspecified consent is sought, its terms and wide-ranging implications should be clearly explained to potential participants. When such consent is given, its terms should be clearly recorded. Subsequent reliance, in a research proposal, on existing unspecified consent should describe the terms of that unspecified consent. See the G-NatlStmt for more information on consent to future use of data and tissue in research. Additionally, see the Consent for Specimen section for more information on consent related to use of tissue in research.

Re-Consent

According to the AU-ICH-GCP and the G-TrialsSOP, any change in the ICF that is relevant to the participant’s consent should be approved by the EC prior to implementing any changes. The participant or legal representative/guardian should also be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented. The G-TrialsSOP further specifies that unless there is a significant safety concern, ECs will not usually require that participants be recontacted immediately since there are potential implications related to blinding. If approved by the EC, continued consent may be obtained verbally and recorded in the participant’s medical records and relevant documents. Re-consent may also be obtained by telephone if approved by an EC.

The G-NatlStmt notes that in some research, consent may occasionally need to be renegotiated or confirmed, especially where projects are complex or long-running, or participants are vulnerable. Research participants should be told if there are changes to the terms to which they originally agreed and given the opportunity to continue their participation or withdraw.

Language Requirements

Pursuant to the G-NatlStmt, methods for presenting research information to participants should take into account the need for accurate and reliable translation into the participant’s first language or dialect, as well as culture and its effects on the communication process. According to the G-TrialsSOP, in cases where translation is required, a professional interpreter should facilitate the process.

Documenting Consent

The AU-ICH-GCP and the G-TrialsSOP state that the participant or legal representative(s)/guardian(s) and the investigator(s) must sign and date the ICF. Where the participant is unable to read or the legal representative/guardian is unable to read, an impartial witness should be present during the entire informed consent discussion. After the following steps have occurred, the witness should sign and date the ICF attesting that the information in the ICF was accurately explained to, and apparently understood by the participant or legal representative/guardian:

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

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

The G-TrialsSOP further indicates that where consent is obtained by telehealth or telephone, once the ICF is signed and dated by both the participant and the investigator (and any other person present, for example an interpreter), the participant must select the statement identifying that consent was obtained by telehealth or telephone with the name of the investigator. Similarly, the investigator must select the statement identifying that consent was obtained by telehealth or telephone with the name of the participant. For more information on informed consent documentation, see the G-TrialsSOP.

According to the G-NatlStmt, consent may be expressed orally, in writing, or by some other means (such as return of a survey or conduct implying consent), depending on the nature, complexity, and level of risk of the research, and the participant’s personal and cultural circumstances.

Waiver of Consent

The G-NatlStmt specifies that although voluntary consent is a requirement for every trial, the EC may approve an alteration to the consent requirements. Limited disclosure to participants of the aims and/or methods of research may be justifiable. However, only an EC can review and approve research that involves active concealment or planned deception or aims to expose illegal activity.

Per the G-NatlStmt, it may be appropriate to use an opt-out approach for participant recruitment when obtaining explicit consent is neither practical nor feasible. An opt-out approach is a method used in the recruitment of research participants where information is provided to the potential participant regarding the research and their involvement, and where their participation is presumed unless they take action to decline to participate. An EC may approve the use of an opt-out approach for research if the study satisfies all of the following conditions:

It involves only low risk to participants
The public interest in the proposed activity substantially outweighs the public interest in the protection of privacy
The research activity is likely to be compromised if the participation rate is not near complete, and the requirement for explicit consent would compromise the necessary level of participation
Reasonable attempts are made to provide participants with appropriate plain language information explaining the nature of the information to be collected, the purpose of collecting it, and procedure to decline participation or withdraw from the research
A reasonable time period is allowed between the provision of information to prospective participants and the use of their data so that an opportunity for them to decline to participate is provided before the research begins
A mechanism is provided for prospective participants to obtain further information and decline to participate
The data collected will be managed and maintained in accordance with relevant security standards
There is a governance process in place that delineates specific responsibility for the project and for the appropriate management of the data
The opt-out approach is not prohibited by state, federal, or international law

According to the G-NatlStmt, only an EC may grant a waiver of consent for research using personal information in medical research, or personal health information. However, other review bodies may grant a waiver of consent for other research. In order to help maintain public confidence in the research process, each institution must make publicly accessible summary descriptions of all its research projects for which consent has been waived.

As stated in the G-NatlStmt, an EC may waive the requirement for consent if the study satisfies all of the following conditions:

Involvement in the research carries no more than low risk to participants
The benefits from the research justify any risks of harm associated with not seeking consent
It is impracticable to obtain consent (for example, due to the quantity, age, or accessibility of records)
There is no known or likely reason for thinking that participants would not have consented if they had been asked
There is sufficient protection of their privacy
There is an adequate plan to protect the confidentiality of data
There is, where practicable, a plan for making information arising from the research available to participants in cases where the results have significance for their welfare
The possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled
The waiver is not prohibited by state, federal, or international law

See the G-NatlStmt for more information on conditions for the opt-out approach or waiving consent.

1, 3, 4, and 8

SOP 09

Sections 2 (Chapters 2.2 and 2.3), 3 (Chapter 3.1), and 5 (Chapter 5.3)

Last content review/update: November 27, 2024

Obtaining Consent

For any biomedical research involving humans in the Democratic Republic of the Congo (DRC), the investigator must obtain the free and informed consent of the prospective participant in accordance with the requirements set forth in the G-EthicalEval, the Declaration of Helsinki (DRC-11), the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10).

As per the G-EthicalEval and DRC-3, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an ethics committee (EC). The G-EthicalEval further states that when reviewing the informed consent process, the EC should review the arrangements for receiving and responding to requests and complaints from research participants or their representatives during the course of a study. (See the Required Elements section for details on what should be included in the form.)

In addition, DRC-3 states that that the participant or legal representative/guardian must be provided with detailed research study information. None of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or to appear to waive their legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

The G-EthicalEval indicates that in the process of obtaining informed consent, sponsors and investigators must refrain from unjustified deception, attempts to exert undue influence, or intimidation. The sponsor and investigator may solicit consent only after making sure that the potential participant understands the details of participation and has been given time to consider it.

Re-Consent

The G-EthicalEval indicates that when material changes occur in the modalities or procedures of a study, or periodically for long-term studies, the investigator must again seek the informed consent of the participants. Sponsors and investigators have a duty to obtain the informed consent of each participant in the event of a significant change in the terms and conditions of the research, or if new information emerges that may affect the willingness of the participants to continue. For example, new pieces of information may have emerged from the study or from other sources (other studies or pharmacovigilance) about the risks or benefits of the products being investigated or about products to replace them. If it changes the risk, then this information must be promptly communicated to the participants. However, the results of the study will be disclosed at the end of the research after analysis of the data.

The sponsor and investigator must also seek renewed informed consent for each participant in long-term studies at predetermined intervals, even if there is no change in the design or objectives of the research.

Language Requirements

The G-EthicalEval requires that the ICF be provided in the language(s) understood by potential participants and, if necessary, in other languages. The investigator must convey the information in the informed consent process, orally and in writing, in a language that corresponds with the level of understanding of the participant. The investigator should also consider that the participant’s ability to understand the information required to express informed consent depends on the maturity, comprehension ability, level of education, and belief system of the participant.

Documenting Consent

According to the G-EthicalEval and DRC-3, the participant or legal representative/guardian must sign the ICF. The G-EthicalEval states that it is advisable to give participants information sheets to keep that may be similar to ICFs, but do not require a signature. The EC must approve the content of the informed consent material. When consent has been obtained orally, investigators are required to provide documentation or evidence of consent.

The G-EthicalEval indicates that if the participant is illiterate, an independent witness must sign the consent. DRC-3 further specifies that where the participant is illiterate or the legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

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

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

Waiver of Consent

The G-EthicalEval states that the EC may authorize, in extraordinary cases, the waiver of a signed consent form, such as in a case where the existence of a signed consent form would constitute an unreasonable threat to the privacy of the participant.

2, 4.4, 4.8, 8.2, and 8.3

Guidelines 13, 16, 24-26, and 35

Required Elements

Last content review/update: September 30, 2025

Based on the AU-ICH-GCP and the G-NatlStmt, both the informed consent discussion and the written informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

That the trial involves research
The purpose of the trial
The trial treatment(s) and the probability for random assignment to each treatment
The trial procedures to be followed, including all invasive procedures
The participant's responsibilities
Those aspects of the trial that are experimental
The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
The reasonably expected benefits, including to the wider community. When there is no intended clinical benefit to the participant, the participant should be made aware of this
The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks
The compensation and/or treatment available to the participant in the event of trial-related injury, including provision of services to participants adversely affected by the research
The amounts and sources of funding for the research, as well as financial or other relevant declarations of interests of researchers, sponsors, or institutions
The anticipated prorated payment, if any, to the participant for participating in the trial
The anticipated expenses, if any, to the subject for participating in the trial
That participation in the trial is voluntary and that the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled
Any implications of withdrawal from the trial, and whether it will be possible to withdraw data
How the research will be monitored
That the monitor(s), the auditor(s), the ethics committee (EC), and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written ICF, the participant or legal representative/guardian is authorizing such access
That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant’s identity will remain confidential
That the participant or legal representative/guardian will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the trial
The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury
Contact details of a person to receive complaints and of the researchers
The foreseeable circumstances and/or reasons under which participation in the trial may be terminated
The expected duration of participation in the trial
The approximate number of participants involved in the trial
The likelihood and form of dissemination of the research results, including publication
Any other relevant information, including research-specific information required under other chapters of the G-NatlStmt

4.8.10

Section 2 (Chapter 2.2)

Last content review/update: November 27, 2024

The G-EthicalEval indicates that the principal investigator must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 provides guidance on the elements to include in the informed consent form (ICF) and states that information about the research study should be clearly presented in both written and oral form.

The G-EthicalEval and DRC-3 state that before seeking the consent of a person to participate in research, the investigator must indicate the following to the person using language or any other form of intelligible communication (Note: the sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each):

That the person is invited to participate in the research as a subject, the reasons for which the person is eligible, and that participation is voluntary
That the person is free to refuse to participate and may at any time terminate participation without being penalized or losing any advantage to which the person would normally have been entitled
The purpose of the research and the procedures to be used by the investigator and the participant, and how the research departs from the usual medical care
For controlled trials, the modalities of the research (randomization, double-blind, etc.) and that the participant will only be informed of the assigned treatment once the study has been completed and the double-blind procedure has ended
The expected duration of participation (including the number and duration of visits to the research center and the resulting total duration) and the possibility of early termination of the trial or participation in the trial
Whether money or other types of material gratuity will be given in return for participation and, if so, their nature and amount
The anticipated expenses, if any, to the participant for participating in the trial
That, after completion of the study, the participant will be informed of the findings of the research in general terms and will be individually informed of any findings regarding the participant’s personal health status
That the participant will be able to access, upon request, data concerning the participant even if these data have no immediate clinical utility
That the participant or legal representative/guardian will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the trial
All risks, pain, or discomfort foreseeable for the participant (or other persons) arising from participation in the research, including risks to the health or well-being of the spouse or partner of the participant
The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
Where appropriate, the direct benefits that the participant can expect from participation in the research
The expected benefits of research for the community or society, or the contributions of this research to scientific knowledge
If, when, and how any of the products or interventions that research has shown to be safe and effective will most likely be made available to the participant after ending participation in the research
Any intervention or alternative treatment currently available
That the monitor(s), the auditor(s), the ethics committee (EC), and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written ICF, the participant or legal representative/guardian is authorizing such access
The arrangements that will be made to ensure the participant’s privacy and the confidentiality of the files where the participant is identified
The legal or other limitations of the investigators' ability to maintain confidentiality and the potential consequences of breaches of confidentiality
The rules applicable to the use of genetic test results and family genetic information, and the precautions taken to prevent the disclosure of genetic test results of a participant to the close family or to third parties without the participant’s consent
The proponents of the research, the institution to which the investigators report, and the nature and sources of funding for the research
Possible uses, direct or secondary, of the participant’s medical record and biological samples collected as part of clinical care
If it is anticipated that the biological samples taken from the research will be destroyed when the research is completed, and if not, a detailed description of how they will be preserved (where, how, for how long, and how it will be disposed of) and the future uses envisaged, and whether the participant has the right to decide on these future uses, to refuse the conservation, and to demand the destruction of the material in question
Whether commercial products can be derived from biological samples, and whether the participant will receive pecuniary or other benefits from the development of such products
If the investigator's sole function is to be an investigator, or both an investigator and the treating physician of the participant
The extent of the investigator's responsibility for providing medical benefits to the participant
That treatment will be provided free of charge for specified types of physical injury related to research or for research-related complications, the nature and duration of such treatment, the name of the organization or individual treatment, and if there are uncertainties about the funding of the treatment
How and by which organization the participant or family, or dependents of the participant, will be compensated for any disability or death resulting from such bodily injury (or, if applicable, that nothing is provided for this purpose)
That an EC has approved or authorized the research protocol (name and date)
Foreseeable circumstances under which the investigator(s) may remove the participant without the participant’s consent
Approximate number of participants involved in the study
The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury

The G-EthicalEval further indicates that this list is not exhaustive, and it is recommended to follow the latest edition of DRC-11, DRC-10, and DRC-3.

4.4 and 4.8

Guidelines 25 and 35

Participant Rights

Last content review/update: September 30, 2025

Overview

In accordance with the AU-ICH-GCP and the G-NatlStmt, Australia’s ethical standards protect participants’ rights and promote respect for human beings, research merit and integrity, justice, and beneficence. The G-NatlStmt further recognizes that state or territory authorities may have additional statutes regarding the use of human tissues, guardianship, and illegal and unprofessional conduct. Furthermore, a participant’s rights must be clearly addressed in the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia).

The Right to Participate, Abstain, or Withdraw

As stated in the AU-ICH-GCP and the G-NatlStmt, the participant or the legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. The G-TrialsSOP further specifies that participants may withdraw their consent at any time without giving a reason.

Per the G-NatlStmt, the participant should be informed of any implications of withdrawal and whether it is possible to withdraw data.

The Right to Information

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

The Right to Privacy and Confidentiality

According to the AU-ICH-GCP and the G-NatlStmt, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. Privacy is also subject to national, state, and territory laws, including the PrivacyAct. As per the G-TrialsSOP, if telehealth is used, all measures must be taken to ensure privacy and confidentiality of the participant’s identity.

See the Personal Data Protection section for more details on personal information collection and handling requirements.

The Right of Inquiry/Appeal

The AU-ICH-GCP and the G-NatlStmt state that the research participant or the legal representative/guardian should be provided with contact information for the individual responsible for addressing trial-related inquiries and/or rights.

AUS-45 provides information on who the participant or the legal representative/guardian may contact regarding a concern with the clinical trial. The options include contacting the researcher(s) directly, the ethics committee (EC) (known as Human Research Ethics Committee in Australia), the institution, the healthcare complaints entity in the state or territory, or the National Health and Medical Research Council (NHMRC). Concerns may also be reported to the Therapeutic Goods Administration (TGA). See AUS-45 for more information on the types of concerns that may be reported to each party.

See the G-NatlStmt for more information on institutional requirements for receipt of complaints.

The Right to Safety and Welfare

The AU-ICH-GCP (which upholds the Declaration of Helsinki (AUS-52)) and the G-NatlStmt clearly state that a research participant’s right to safety and protection of health and welfare must take precedence over the interests of science and society.

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

Introduction, 2, and 4

SOP 09

Purpose, Scope, and Limits of this Document, Section 1, Section 2 (Chapters 2.2 and 2.3), and Section 5 (Chapter 5.7)

Part II

Last content review/update: November 27, 2024

Overview

As delineated in the G-EthicalEval, a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process.

In addition, the G-EthicalEval states that the principal investigator (PI) should closely follow the guidelines provided by the Declaration of Helsinki (DRC-11), the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the Council for International Organizations of Medical Sciences’ (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects (DRC-2).

(See the Required Elements, Vulnerable Populations, and Children/Minors sections for additional information regarding requirements for participant rights.)

The Right to Participate, Abstain, or Withdraw

As set forth in the G-EthicalEval and DRC-3, the participant should be informed that participation is voluntary, and that the participant may withdraw from the research study at any time without being penalized or losing any advantage to which the participant would normally have been entitled.

The Right to Information

As delineated in the G-EthicalEval and DRC-3, a potential research participant has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, and any potential benefits, risks, or constraints. (See the Required Elements section for more detailed information regarding participant rights.)

The G-EthicalEval further states that information collected during the study should be shared with the indigenous community in the research community. Researchers must consider community input and allow dissenting voices to speak in public if differences of opinion were not resolved earlier.

The Right to Privacy and Confidentiality

According to the G-EthicalEval and DRC-3, the participant should be informed of arrangements that will be made to ensure the participant’s privacy and the confidentiality of the files where the participant is identified.

The Right of Inquiry/Appeal

DRC-3 states that the research participant or legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of the participant’s rights. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Safety and Welfare

The G-EthicalEval states that the PI is responsible for the well-being and integrity of the participants. In addition, the principles in DRC-3 state that a research participant’s right to safety and the protection of the participant’s health and welfare must take precedence over the interests of science and society.

2, 3.1, and 4.8

Guidelines 25, 35, and 36

Emergencies

Last content review/update: September 30, 2025

The AU-ICH-GCP states that in emergency situations, when prior consent of the participant is not possible, the consent of the legal representative/guardian, if present, should be requested. When prior consent of the participant is not possible, and the legal representative/guardian is not available, enrollment of the participant should require measures described in the protocol and/or elsewhere, with documented approval/favorable opinion by the ethics committee (EC) (known as the Human Research Ethics Committee in Australia), to protect the rights, safety, and well-being of the participant and to ensure compliance with applicable regulatory requirements, including the G-NatlStmt. Per the AU-ICH-GCP, the participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

The G-NatlStmt recognizes that in emergency care research, recruitment into a research project often must be achieved rapidly. Where the research involves emergency treatment and meets the G-NatlStmt’s requirements for research involving people highly dependent on medical care, consent for the research may be waived. See the Vulnerable Populations section for more information on people highly dependent on medical care, and the Documentation Requirements section for more details on waiver of consent.

4.8.15

Section 4 (Chapter 4.4)

Last content review/update: November 27, 2024

According to the G-EthicalEval, the principal investigator must agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by emergencies.

Per DRC-3, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or legal representative/guardian, or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

4.8

Guideline 35

Vulnerable Populations

Last content review/update: September 30, 2025

Overview

The AU-ICH-GCP characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation in a clinical trial, or of a retaliatory response for not participating. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, residents of nursing homes, unemployed or impoverished persons, patients in emergency situations, homeless persons, nomads, refugees, minors, and those incapable of giving consent. Per the G-NatlStmt, people who may be involved in illegal activities, Aboriginal and Torres Strait Islander peoples, ethnic minority groups, and people in other countries are other groups for which specific ethical considerations are required.

People Highly Dependent on Medical Care

According to the G-NatlStmt, research involving people who are highly dependent on medical care may be approved where:

It is likely that the research will lead to increased understanding about, or improvements in, the care of this population
The requirements of relevant jurisdictional laws are taken into account
Either: 1) any risk or burden of the proposed research to this particular participant is justified by the potential benefits, or 2) where participants have capacity to consent, any risk or burden is acceptable to them and justified by the potential benefits of the research

The G-NatlStmt indicates that when a researcher is also the treating health professional, it should be considered whether an independent person should seek the consent of potential participants who are highly dependent on medical care. In addition, the participant and/or the participant’s relatives and an authorized representative should be informed of the participant’s inclusion in the research and of the option to withdraw from it without any reduction in quality of care.

The G-NatlStmt states that when neither the potential participant nor the legal representative/guardian can consider the proposal and give consent, an ethics committee (EC) (known as the Human Research Ethics Committee in Australia) may, having taken account of relevant jurisdictional laws, approve a research project without prior consent if:

There is no reason to believe that, were the participant or legal representative/guardian to be informed of the proposal, the participant would be unwilling to consent
The risks of harm to individuals, families, or groups linked to the participant, or to their financial or social interests, are minimized
The project is not controversial and does not involve significant moral or cultural sensitivities in the community

And, where the research is interventional, these additional conditions apply:

The research supports a reasonable possibility of benefit over standard care
Any risk or burden of the intervention to the participant is justified by its potential benefits
Inclusion in the research project is not contrary to the interests of the participant

The G-NatlStmt further provides specific requirements related to conducting research on participants in terminal care, which is characterized by the short remaining life expectancy of the participants and their vulnerability to unrealistic expectations of benefits. Terminal care research should be designed so that the benefits of research justify any burden, discomfort, or inconvenience to the participants; the prospect of benefit from research participation is not exaggerated; the needs and wishes of participants to spend time as they choose are respected; and the entitlement of those receiving palliative care to participate is recognized.

Aboriginal and Torres Strait Islander Peoples

The G-NatlStmt states that research involving Aboriginal and Torres Strait Islander Peoples must be reviewed and approved by an EC and include assessment and advice from: people who have networks with and/or knowledge of Aboriginal and Torres Strait Islander Peoples; and people familiar with the culture and practices of the relevant Aboriginal and Torres Strait Islander community(ies). In addition, the researcher should ensure the following:

Research methods are respectful and acknowledge the cultural distinctiveness of participating Aboriginal and Torres Strait Islander communities and groups
There is evidence of support for the research project from relevant Aboriginal and Torres Strait Islander communities or groups and the research methodology engages with their social and cultural practices
The research methods provide for mutually agreed upon mechanisms for recruitment, information provided about the research, notification of participants’ consent and of research progress, and final reporting
Procedures and actions have been taken to monitor and, where appropriate, minimize any potential negative consequences of the proposed research

For more information on research involving Aboriginal and Torres Strait Islander Peoples, see the G-AboriginalEthic, the G-EthicsRsrchTrackII, and the G-AIATSISCode.

People in Dependent Groups

The G-NatlStmt cautions that dependent or unequal relationships that might compromise the voluntary character of a participant’s decision should be considered. Examples of such relationships include caregivers and people with chronic conditions/disabilities; health care professionals and their patients; teachers and their students; prison authorities and prisoners; governmental authorities and refugees; employers/supervisors and their employees (including members of police and Defense Forces); and service-providers and especially vulnerable communities to whom the services are provided. Where potential participants are especially vulnerable or powerless, consideration should be given to the appointment of a participant advocate.

Per the G-NatlStmt, when a researcher and potential participant have a pre-existing relationship, it should be considered whether an independent person should seek the consent of the participant.

People Who May Be Involved in Illegal Activities

The G-NatlStmt provides specific requirements related to conducting research on participants who may be involved in illegal activities. Research that is intended to study or expose, or likely to expose, illegal activity should be reviewed and approved by an EC. Researchers should be satisfied that participants who are subject to criminal justice processes are aware that the research may discover illegal activity and do not have unrealistic expectations of benefit from their participation. Finally, research designed to expose illegal activity should only be approved where the illegal activity bears on the discharge of a public responsibility or the fitness to hold public office, the risks are justified by the benefits, and the research meets the other requirements in the G-NatlStmt.

People in Other Countries

The G-NatlStmt states that research involving people in other countries must be reviewed and approved by an EC and comply with the G-NatlStmt. The research design, protocol, and consent process should take into consideration the local cultural values, yet still result in participants being treated with no less respect and protection than what is provided in the G-NatlStmt. Additional details are provided in the G-NatlStmt.

1

Section 4 (Introduction and Chapters 4.1, 4.3-4.4, and 4.6-4.8)

Last content review/update: November 27, 2024

Overview

In all clinical trials in the Democratic Republic of the Congo (DRC), research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process in accordance with the G-EthicalEval. Vulnerable populations, which have a limited ability to give informed consent, include children and adolescents, adults with serious mental or behavioral disorders, people with reduced levels of consciousness, pregnant women, prisoners, and socio-economically disadvantaged individuals. Research on these populations must be justified in detail, and efforts must be made to obtain the consent of the legal guardian(s) of these participants.

In addition, the G-EthicalEval requires principal investigators to work in accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 includes the following as vulnerable populations: members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students; subordinate hospital and laboratory personnel; employees of the pharmaceutical industry; members of the armed forces; and persons kept in detention. Other vulnerable populations include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

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

Indigenous Peoples

According to the G-EthicalEval, special provisions must also be made for research related to the traditional or sacred knowledge of an indigenous community, or its members as indigenous people. The researcher should consult with community leaders and obtain their consent before approaching members individually. After obtaining the consent of the community, the researcher must still make sure to have the prior free and informed consent of each participant.

The G-EthicalEval further states that it is advisable to establish an informed consent process for communities and individual participants early in the research process or authorization, which should take into account the legitimate decision-making processes of communities at all stages of the process.

1.61 and 4.8

Guidelines 24, 28, and 35, and Glossary

Children/Minors

Last content review/update: September 30, 2025

The FamLawAct defines a child as a person who is under 18 years of age. Per AUS-71, different states or territories may have specific legislation about a parent/guardian providing consent to medical treatment for a minor; otherwise, the FamLawAct has provisions that may apply.

According to AUS-71, children under 16 cannot give legal consent, which must be given by a parent/guardian, but they can and should be involved in the decision. Young people over 16 can give legal consent to medical treatment; however, they usually cannot provide legal consent to participate in research until they are 18. Nonetheless, some ethics committees (ECs) (known as Human Research Ethics Committees in Australia) do allow mature young people under 18 to give their consent for some kinds of research.

The AU-ICH-GCP states that minors should be informed to the extent compatible with their maturity and understanding, and if capable, they should sign and personally date the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia). In accordance with the G-NatlStmt, consent requirements for conducting clinical trials follow the general requirements listed in the Required Elements section.

The G-NatlStmt states before including a child or young person in research, researchers must establish that there is no reason to believe that such participation is contrary to that child's or young person's best interest. Furthermore, a child or young person's refusal to participate in research should be respected wherever the child or young person has the capacity to give consent to that same research. Where a child or young person lacks this capacity, the child or young person’s refusal may be overridden by the judgement of the parent/guardian as to what is in the child's best interest.

The G-NatlStmt indicates that an EC may approve research to which only the child or young person consents if it is satisfied that:

The child or young person is mature enough to understand the relevant information and give consent
The research involves low risk
The research aims to benefit children or young people
The child or young person is estranged or separated from the parent/guardian and the researcher ensures the child or young person’s safety, security, and well-being in the research conduct; or it would be contrary to the best interests of the child or young person to seek consent from the parent/guardian, and the researcher ensures the child or young person’s safety, security, and well-being in the research conduct

In addition, as stated in the G-NatlStmt, children and young people who are not of sufficient maturity to consent should only participate in clinical studies when: the research is likely to advance knowledge about the health or welfare of, other matters relevant to, children and young people; or their participation is indispensable to the conduct of the research. When considering the inclusion of children and young people in research, the researchers and EC must consider their level of maturity to ensure adequate protections for their welfare.

Assent Requirements

AUS-71 indicates that when a parent/guardian gives consent for their child to take part in a clinical trial, researchers may also ask the child for their permission or agreement, also referred to as assent. The researchers must do this in an age-appropriate manner. Both the parent/guardian and the child should have the chance to ask any questions before agreeing to participate and at any time during a trial. In order for a child to provide their consent or assent they must:

Understand the research process
Understand the purpose of the trial
Be told what they are expected to do or what will happen to them during the trial

AUS-71 further states that children should be able to express their views and any worries they might have about participating in a trial, and have their questions answered. Children should always be given information in a form that they can understand. Additionally, AUS-80 indicates that refusal to assent or withdrawal of assent by a child should be respected. Over the course of a clinical study, it may be necessary to reassess the assent of a child in recognition of their advancing age, evolving maturity, and competency, especially for long-term studies or studies that may require sample retention. During clinical studies, it is required to obtain adequate informed consent for continued participation from pediatric participants once a child reaches the age of legal consent. Local regulations related to confidentiality and privacy of pediatric participants must be followed.

Furthermore, the G-NatlStmt states that except in cases involving standing parental consent, specific consent must be obtained from the child or young person whenever the child or young person has the capacity to make this decision, and either one (1) parent, except when the EC decides that the risks require the consent of both parents, or the child or young person’s parent/guardian.

Per the G-NatlStmt, researchers must respect the developing capacity of children and young people to be involved in decisions about participation in research. The child or young person's particular level of maturity has implications for whether consent is necessary and/or sufficient to authorize participation. However, it is not possible to attach fixed ages to each level of maturity, which may vary from child to child. The following guidelines on maturity and corresponding capacity to consent are provided:

Infants, who are unable to take part in discussion about the research and its effects
Young children, who are able to understand some relevant information and take part in limited discussion about the research, but whose consent is not required
Young people of developing maturity, who are able to understand the relevant information but whose relative immaturity means that they remain vulnerable; the consent of these young people is required, in addition to consent from a parent or guardian
Young people who are mature enough to understand and consent, and are not vulnerable through immaturity in ways that warrant additional consent from a parent or guardian

See the G-NatlStmt for more information on consent and assent involving children and young people.

Clinical trials and children

4

Section 4 (Chapter 4.2)

Part I-Preliminary (4 Interpretation)

Last content review/update: November 27, 2024

According to the FamilyCodeMemo, the age of majority is 18 years old in the Democratic Republic of the Congo (DRC).

The G-EthicalEval recommends that children be included in the decision to participate in research based on their physical, psychological, and social developmental abilities. In addition, the G-EthicalEval requires principal investigators to work in accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), which states that when a clinical trial includes minors, the minors should be informed about the trial to the extent compatible with their understanding and, if capable, should sign and personally date the written informed consent.

Assent Requirements

As per the G-EthicalEval, a child's ability to give informed assent to participate in research is globally established at the minimum age of 13. The research team should consider the complexity of the research and other aspects to raise this age, but never go below it. A minor’s parent/legal guardian must provide consent for the minor to participate in the research. Once the minor reaches the minimum age of 13, the minor must also give assent. It is therefore necessary to first obtain the consent of the parent/legal guardian, and then the assent of the child.

The G-EthicalEval further indicates that the refusal of the parent/legal guardian or child constitutes dissent and precludes the child's participation in the research.

4.8

Guidelines 27 and 35

Book II (Section 3)

Pregnant Women, Fetuses & Neonates

Last content review/update: September 30, 2025

As per the G-NatlStmt, studies involving pregnant women, fetuses, and neonates require additional safeguards to ensure that the research assesses the risks to the pregnant women, fetuses, and neonates. The wellbeing and care of the woman who is pregnant and of her fetus always takes precedence over research considerations, and research involving a fetus or fetal tissue should be conducted in a manner that maintains a clear separation between the woman’s clinical care and the research. Additionally, research should be designed to minimize pain or distress for the fetus, include steps for monitoring for signs of fetal pain or distress, and include steps for suspending or ceasing the research if necessary.

In accordance with the G-NatlStmt, consent requirements for conducting clinical trials follow the general requirements listed in the Required Elements section. However, except for therapeutic innovative therapy cases, the process of providing information and obtaining consent for participating in research should be clearly separate from clinical care if the woman is pregnant and the fetus is in utero. Further, per the G-NatlStmt, the woman should be informed of the following:

That she should consider whether to seek consent to the proposed research from any other person (e.g., the other parent)
Whether it is possible to store the fetus or fetal tissues for later use in research
That she is free to withdraw her consent to the research at any time, whether before or after a termination or other loss of a fetus
Whether there is potential for commercial application of outcomes of the research, including the development of cell lines
That she will not be entitled to a share in the profits of any commercial applications
Whether fetal organs or stem cell lines developed from them will be exported to another country

In addition, the G-NatlStmt states that if, for research purposes, fetal cells are to be derived from the fetal tissue and stored or propagated in tissue culture, or tissues or cells are to be used in human transplantation, the woman's consent is required. Others whom the woman identifies may also need to be involved in decisions about these matters.

For requirements related to assisted reproductive technology, including research involving the creation of human embryos using precursor cells from a human embryo or a human fetus, see the G-EthicsART.

Section 4 (Chapter 4.1)

Last content review/update: November 27, 2024

While G-EthicalEval lists pregnant women as a vulnerable population, there are no relevant provisions regarding any special consent procedures for pregnant women, fetuses, or neonates.

However, the G-EthicalEval requires principal investigators to work in accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), which states that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

4.8

Guidelines 24 and 35, and Glossary

Prisoners

Last content review/update: September 30, 2025

The G-NatlStmt refers to prisoners and prison authorities as an example of people who may be in dependent or unequal relationships.

Per the G-NatlStmt, a research study involving people in dependent or unequal relationships (such as prisoners) should, wherever possible, invite prospective participants to discuss their participation with someone who is able to support them in making their decision. If prospective participants are especially vulnerable, researchers should consider appointing a participant advocate.

Section 4 (Chapter 4.3)

Last content review/update: November 27, 2024

While G-EthicalEval lists prisoners as a vulnerable population, there are no relevant provisions regarding any special consent procedures for them.

Guideline 24 and Glossary

Mentally Impaired

Last content review/update: September 30, 2025

Cognitive Impairment, Intellectual Disability, or Mental Illness

The G-NatlStmt discusses the requirements for research involving participants with cognitive impairment, intellectual disability, and mental illness together, noting that many of the ethical issues they raise about research participation are similar. An ethics committee (EC) (known as Human Research Ethics Committee in Australia) must review and approve research involving such participants, except where the research uses collections of non-identifiable data and involves negligible risk.

Per the G-NatlStmt, the research design should take into account factors that may affect the capacity to receive information, to consent to the research, or to participate in it. Additionally, care should be taken to determine whether the participant’s cognitive impairment, intellectual disability, or mental illness increases the susceptibility to some forms of discomfort or distress. Ways of minimizing effects of this susceptibility should be described in the research proposal.

As delineated in the G-NatlStmt, the participant must consent if the participant has the capacity, or the participant’s legal representative/guardian must consent on behalf of the participant. Where a legal representative/guardian has given consent, the researchers still must explain to the participant what the research is about and what participation involves. If the participant recovers the capacity to consent, the researcher should offer the opportunity to continue participation or withdraw. Refusal or reluctance to participate in a research project should be respected.

The G-NatlStmt states that if the participant’s impairment, disability, or illness is temporary or episodic, researchers should seek consent when the condition does not interfere with the capacity to give consent. This consent should occur in the presence of a witness who is familiar with the participant, is independent from the research, and understands the research’s merits, risks, and procedures.

Research Involving Unconscious Persons

The G-NatlStmt states when prior consent is not possible for research involving unconscious persons, consent should be provided by the participant’s legal representative/guardian. However, relevant jurisdictional laws must be taken into account. Because of their extreme vulnerability, unconscious persons should be excluded from all but minimally invasive research, or in research designed both to be therapeutic for them and to improve treatment for the condition from which they suffer.

The G-TrialsSOP notes that as per the Declaration of Helsinki (AUS-52), for research involving participants who are physically or mentally incapable of giving consent (e.g., unconscious patients/participants), the study must be relevant to the physical or mental condition of the participant(s) that prevents them from being able to consent to participate in the study.

SOP 09

Section 4 (Chapters 4.4 and 4.5)

Last content review/update: November 27, 2024

While G-EthicalEval lists adults with serious mental or behavioral disorders as a vulnerable population, there are no relevant provisions regarding any special consent procedures for them.

However, the G-EthicalEval requires principal investigators to work in accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), which states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participants should be informed about the trial to the extent compatible with their understanding and, if capable, they should sign and personally date the written informed consent.

1.61, 3.1, and 4.8

Guidelines 24 and 35, and Glossary

Definition of Investigational Product

Last content review/update: September 30, 2025

According to the AU-ICH-GCP and the G-TrialsSOP, an investigational product (IP) is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when used or assembled (formulated or packaged) in a different way from the approved form; when used for an unapproved indication; or when used to gain further information about an approved use.

The G-CTHandbook adds that an IP is any therapeutic good being tested or used as reference in a clinical trial. Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) (AUS-22) before those goods can be lawfully imported into, exported from, or supplied in Australia. The Clinical Trial Notification (CTN) and the Clinical Trial Approval (CTA) schemes provide for the lawful importation into and/or supply in Australia of unapproved therapeutic goods for use solely for experimental purposes in humans. When a product is included in the ARTG, the entry applies to a particular sponsor (i.e., the individual or company intending to supply the goods). If a same or similar product is imported by another company or individual it is considered “unapproved”.

As per the G-CTHandbook, unapproved therapeutic goods include:

Any medicine, biological, or medical device not entered on the ARTG, including any new formulation, strength or size, dose, name, indications, directions for use or type of container of a medicine already in the ARTG
Therapeutic goods already in the ARTG to be used in a manner not covered by the existing ARTG entry

Determine the type of therapeutic good and Determine if the product is ‘unapproved’

1

Terms

Last content review/update: November 27, 2024

As delineated in the G-PV and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), an investigational product (IP) is defined as a pharmaceutical form of an active ingredient being studied or used as a reference in a clinical trial. This includes products already authorized but used or formulated and packaged in a different way from the authorized version, when used for an unauthorized indication, or when used to gain further information about an approved use.

The G-EthicalEval indicates that the principal investigator must agree to work in accordance with DRC-3.

1.33

Guideline 35

I (I.1)

Manufacturing & Import

Last content review/update: September 30, 2025

Manufacturing

As specified in the TGAct and the G-CTHandbook, the Therapeutic Goods Administration (TGA) authorizes the manufacture of investigational products (IPs) (i.e., therapeutic goods being used in a clinical trial) in Australia. As per AUS-88 and AUS-49, the sponsor provides manufacturing and/or active ingredient information to the TGA in the clinical trial application under one (1) of the two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme. AUS-49 indicates that as part of a CTN scheme application involving a medicine or biological, the sponsor must provide either the TGA-issued good manufacturing practice (GMP) license, the GMP certification (for overseas manufacturers), or a relevant exemption.

Pursuant to TGManuf, Australia adopted the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products, PE 009-17 (AU-PIC-S-GMP-Guide) regarding the manufacture of therapeutic goods. Per the AU-PIC-S-GMP-Guide, the holder of a manufacturing authorization must manufacture IPs to ensure that they are fit for their intended use, comply with the requirements of the clinical trial authorization, and do not place participants at risk due to inadequate safety, quality, or efficacy. The production of IPs involves added complexity in comparison to marketed products and therefore requires personnel with a thorough understanding of, and training in, the application of GMP to IPs. For manufacturers to be able to apply and comply with GMP for IPs, cooperation between manufacturers and sponsors of clinical trials is required.

Additionally, the principles of the AU-PIC-S-GMP-Guide on certification by an authorized person and batch release also apply to IPs for human use. Although the ultimate responsibility for the performance of a medicinal product over its lifetime, as well as its safety, quality, and efficacy, lies with the marketing authorization holder, the authorized person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with national requirements in accordance with the requirements of the marketing authorization and with GMP.

See the AU-PIC-S-GMP-Guide for detailed manufacturing requirements. Additionally, see AUS-95 for the TGA’s summary of the changes in version 17 of the AU-PIC-S-GMP-Guide.

Import

The G-CTHandbook indicates that IPs may be imported and held under the direct control of the sponsor (importer) until the IPs are the subject of a notification to the TGA under the CTN scheme or an approval under the CTA scheme. The IPs must be kept in a warehouse or other properly secured area. There is no requirement for the CTN or CTA process to have been completed prior to importation of the clinical trial goods.

Creating a New CTN Form

The CTN and CTA schemes, Manufacturing, and Importing

Part I (Chapter 1 (Principle)), Annex 13 (Introduction), and Annex 16

Part 1 (Section 4) and Schedule 1 (Part 1)

Chapter 3 (Part 3-2 (19) and Part 3-3 (34-38))

Last content review/update: November 27, 2024

As per D-ACOREP and DRC-15, the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention), in collaboration with the relevant foreign trade ministry, is responsible for authorizing and controlling drug manufacture and imports in the Democratic Republic of the Congo (DRC).

The G-EthicalEval requires that the principal investigator agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 requires investigational products (IPs) to be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP) and used in accordance with the approved protocol.

According to DRC-12, an import license is required for the shipment of the IP to be used in the trial. The sponsor may apply for IP import approval through ACOREP’s Digital Platform (DRC-13).

Please note: DRC is party to the Nagoya Protocol on Access and Benefit-sharing (DRC-1), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see DRC-7.

2.12 and 5.13

Title II (Article 4)

Guidelines 2 and 35

Quality Requirements

Last content review/update: September 30, 2025

Investigator’s Brochure

According to the AU-ICH-GCP, the sponsor is responsible for providing the investigators with an investigator’s brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs), including significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information. The sponsor must ensure that an up-to-date IB is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee. (Note: In Australia, therapeutic goods being used in a clinical trial are IPs.)

According to the G-TrialsSOP, where the investigator contributes to the content and development of the IB, the investigator must ensure the IB follows the outline in the AU-ICH-GCP. The AU-ICH-GCP requires the IB to cover 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; and regulatory and post-marketing experiences)

Summary of data and guidance for the investigator(s)

See Section 7 of the AU-ICH-GCP for detailed content guidelines.

Quality Management

As specified in the AU-ICH-GCP, the sponsor must ensure that the products are manufactured in accordance with Good Manufacturing Practice (GMP). Furthermore, the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

Per the AU-PIC-S-GMP-Guide, GMP ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the clinical trial authorization. A pharmaceutical quality system designed, set up, and verified by the manufacturer or importer should be described in written procedures, taking into account the guidance in Chapter 1 or Part I of the AU-PIC-S-GMP-Guide. Manufacturers should maintain documentation including specifications and instructions; the IP order; manufacturing formulae and processing instructions; packaging instructions; and batch records. The product specifications and manufacturing instructions may be changed during development, but full control and traceability of the changes should also be maintained. The product specification file should be continually updated as development of the product proceeds, ensuring appropriate traceability to the previous versions.

See the AU-PIC-S-GMP-Guide for more details on quality system and documentation requirements.

5, 7, and 8

SOP 04

Part I (Chapter 1 (1.8)) and Annex 13 (2. Pharmaceutical Quality System and 5. Documentation)

Last content review/update: November 27, 2024

Investigator’s Brochure

The G-EthicalEval indicates that the principal investigator must agree to work in accordance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (DRC-3), which provides detailed Investigator’s Brochure (IB) requirements. DRC-3 specifies that the IB must contain all of the relevant information on the investigational product(s) (IP(s)) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse event data. The sponsor should also update the IB as significant new information becomes available.

As specified in DRC-3, the IB must include the following sections:

Table of Contents
Summary
Introduction
Physical, Chemical, and Pharmaceutical Properties and Formulation
Nonclinical Studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
Effects in Humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
Summary of Data and Guidance for the Investigator(s)

See DRC-3 for detailed content guidelines.

Quality Management

In accordance with the G-EthicalEval, an applicant must provide the ethics committee (EC) with the following IP information in the clinical trial application submission:

An adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the IP to be evaluated
A summary of the clinical experience to date with this IP (e.g., recent IB, publication(s), and summarized product characteristics)

Per DRC-3, the sponsor must maintain a Certificate of Analysis (CoA) to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

5.13, 5.14, 7, and 8.2

Guidelines 13 and 35

Labeling

Last content review/update: September 30, 2025

Investigational product (IP) labeling must comply with the requirements set forth in the G-CTHandbook, the AU-ICH-GCP, and the AU-PIC-S-GMP-Guide. (Note: In Australia, therapeutic goods being used in a clinical trial are IPs.) Per the AU-PIC-S-GMP-Guide, as annotated by the G-CTHandbook, the following information must be included on the IP label:

Sponsor’s name, address, and phone number. The main contact details for information on the product, clinical trial, and emergency unblinding must be an Australian contact
Pharmaceutical dosage form, route of administration, and quantity of dosage units. For closed blinded trials, the labeling should include a statement indicating “placebo or [name/identifier] + [strength/potency]”
The batch and/or code number to identify the contents and packaging operation
A trial reference code, which should identify the particular trial site, unless provided elsewhere or its absence can be justified. The trial reference code used should also identify the Australian trial sponsor, unless provided as the main contact or its absence can be justified
The trial participant identification number/treatment number
Investigator’s name. The name of the principal investigator should appear on the label unless already included in a trial reference code or unless its absence can be justified
Directions for use
“For clinical trial use only” or similar wording
The storage conditions
The period of use (use-by date, expiry date, or re-test date as applicable) in month/year format and in a manner that avoids any ambiguity
“Keep out of reach of children” except when the product is not taken home by participants

The G-CTHandbook recognizes that in exceptional circumstances, it may not be possible to meet the requirements of Annex 13 of the AU-PIC-S-GMP-Guide for labeling IPs. In this case, the sponsor must contact the Therapeutic Goods Administration (TGA) (see AUS-23) if they wish to request a departure from the requirements of Annex 13.

In addition, the AU-ICH-GCP states that the IP must be coded and labeled in a manner that protects the blinding, if applicable.

Per the G-CTHandbook, labeling is a manufacturing step under the TGAct. However, an exemption from the requirement to hold a manufacturing license may apply to certain persons identified within the TGR, to allow relabeling of the IP with name and address of the new sponsor. If there is a change of Australian trial sponsor, the clinical trial medication should be relabeled appropriately with the details of the new trial sponsor at the time of transfer. See the G-CTHandbook for more details on these manufacturing exemptions.

Additional details on IP labeling are provided in the G-CTHandbook and the AU-PIC-S-GMP-Guide.

Manufacturing

5.13

Annex 13 (6.6 Labelling)

Chapter 3 (Part 3)

Schedule 8

Last content review/update: November 27, 2024

The G-EthicalEval requires that the principal investigator agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (DRC-3). DRC-3 provides guidance on labeling of investigational products, stating that they should be coded and labeled in a manner that protects the blinding, if applicable. Per DRC-12, labeling materials must be included in the clinical trial application to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention).

5.13

Guidelines 2 and 35

Product Management

Last content review/update: September 30, 2025

Supply, Storage, and Handling Requirements

As stated in the AU-ICH-GCP, the sponsor must supply the investigator(s) with the investigational product(s) (IP(s)) (i.e., therapeutic good(s) being used in a clinical trial). The G-CTHandbook indicates that Therapeutic Goods Administration (TGA) approval through the Clinical Trial Approval (CTA) scheme or notification through the Clinical Trial Notification (CTN) scheme must occur prior to supplying the IP(s) to the trial site(s).

The AU-ICH-GCP specifies that the sponsor must ensure the following:

Timely delivery of the IP(s)

Records maintained for IP document shipment, receipt, disposition, return, and destruction

A system for retrieving or disposing of IP(s) and documenting this retrieval or disposal

Written procedures including instructions for IP handling and storage, adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
IP product quality and stability over the period of use
IP manufactured according to any application of the Good Manufacturing Practice (GMP)
Proper coding packaging, and labeling of the IP(s)
Acceptable IP handling and storage conditions and shelf-life

In addition, the AU-ICH-GCP states that the IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. Refer to the AU-ICH-GCP for detailed sponsor-related IP requirements.

As per the G-TrialsSOP, responsibility for IP management and accountability at the trial site rests with the principal investigator (PI). However, the PI may delegate responsibility for IP management to the site pharmacist or, where a pharmacist is not available or involved, to an appropriately qualified person. The site pharmacist or the appropriately qualified person will undertake IP management at the primary site and/or the satellite site in a teletrial. The investigator, pharmacist, or appropriately qualified non-pharmacist must ensure the IP is used only in accordance with the approved protocol and confirm IP certification and all relevant trial approvals/notifications are in place before releasing the IP for dispensing to participants. Refer to the G-TrialsSOP for detailed investigator-related IP requirements.

The AU-PIC-S-GMP-Guide indicates that the manufacturer or sponsor’s representative should destroy IPs only with prior written authorization by the sponsor. The arrangements for destruction of IPs must be described in the protocol. Any related arrangement between the sponsor and manufacturer should be defined in their technical agreement. Destruction of unused IPs should be carried out only after reconciliation of delivered, used, and recovered products and after investigation and satisfactory explanation of any discrepancies upon which the reconciliation has been accepted.

Record Requirements

According to the G-TrialsSOP, the investigator, pharmacist, or appropriately qualified non-pharmacist must maintain records of all IP management aspects. These records at a minimum should include: shipping documents; date of each transaction; quantities; batch/serial numbers; expiration dates/retest dates (if applicable); temperature logs showing the storage conditions of the IP throughout the trial period; the set of unique code numbers assigned to the IP and to the trial participant; and record of destruction/return.

As set forth in the AU-ICH-GCP, the sponsor must retain essential documents for 15 years following completion of the trial. The sponsor should inform the investigator(s) and institution(s) in writing when record retention is needed and when the trial-related records are no longer needed. Per the AU-PIC-S-GMP-Guide, documents which are part of the product specification file must be retained for at least five (5) years. If the sponsor and the manufacturer are not the same entity, the sponsor must make appropriate arrangements with the manufacturer to fulfil the sponsor’s requirement to retain the clinical trial master file. Arrangement for retention of such documents and the type of documents to be retained should be defined in an agreement between the sponsor and manufacturer.

Importing

5 and 7

SOP 11

Annex 13 (5. Documentation and 11.3 Destruction)

Last content review/update: November 27, 2024

Supply, Storage, and Handling Requirements

The G-EthicalEval requires that the principal investigator agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3).

Per DRC-3, the sponsor must supply the investigator(s)/institution(s) with the investigational product(s) (IP(s)). The sponsor should not supply either party with the IP(s) until the sponsor obtains all required documentation. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.

The sponsor must ensure the following:

IP product quality and stability over the period of use
IP manufactured according to any applicable Good Manufacturing Practice (GMP)
Proper coding, packaging, and labeling of the IP(s)
Records maintained for document shipment, receipt, disposition, return, and destruction of the IP(s)
Acceptable storage temperatures, conditions, and times for the IP(s)
Timely delivery of the IP(s)
Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
Maintain sufficient quantities of the IP(s) to reconfirm specifications, should this become necessary

Record Requirements

Per DRC-3, the sponsor should comply with the following records requirements:

Maintain records that document shipment, receipt, disposition, return, and destruction of the IP(s)
Maintain a system for retrieving IPs and documenting this retrieval (e.g., for deficient product recall, reclaim after trial completion, and expired product recovery)
Maintain a system for the disposition of unused IP(s) and for the documentation of this disposition

2.12, 5.5, and 5.12-5.14

Guidelines 2 and 35

Definition of Specimen

Last content review/update: September 30, 2025

In Australia, a specimen is referred to as a “biological” or a “human biospecimen.” According to the TGAct, a biological is made from, or contains, human cells or human tissues that are likely to be taken to:

Treat or prevent disease, ailment, defect, or injury
Diagnose the condition of a person
Alter the physiological processes of a person
Test the susceptibility of a person to disease
Replace or modify a person’s anatomy

The G-NatlStmt defines human biospecimen as any biological material obtained from a person, including tissue, blood, urine, sputum, and any derivative from these including cell lines.

Legislation in Australian states and territories do not use standard terminology, but generally refer to human biospecimens as “human tissue.”

Section 3 (Chapter 3.2)

Chapter 3 (Part 3-2A)

Last content review/update: November 27, 2024

In the G-EthicalEval, a specimen is referred to as a “biological sample.” The G-EthicalEval does not define biological samples, but indicates that they should be considered a loan made to the investigator, unless otherwise specified in the research agreement. This requirement is inspired by the philosophies of the Bantu community on “bodily integrity,” according to which every product and part of the human body is an essential and sacred component of the person. The investigator should therefore be considered the guardian of the samples, rather than the owner.

Guideline 34

Specimen Import & Export

Last content review/update: September 30, 2025

Import

Per the G-NatlStmt, if a human biospecimen will be, or has been, imported for research, researchers must establish whether the human biospecimen was obtained in a manner consistent with the requirements of the G-NatlStmt and relevant Australian legislation. If this cannot be established, then the human biospecimen should not be used for research in Australia.

Per the G-CTHandbook, other legislation and requirements may impose restrictions on the import of therapeutic goods for clinical trials involving materials of biological origin (human, animal, plant, or microbial), genetically modified organisms, and other substances. See the G-CTHandbook for a non-exhaustive list.

Export

The G-NatlStmt states that a human biospecimen obtained in Australia may be sent overseas for research if its exportation is consistent with the original consent, and if ethics committee (EC) (known as a Human Research Ethics Committee in Australia) approval is obtained.

Per the G-SpecExport, a permit to export human body fluids, organs, and other tissue must be obtained from the Therapeutic Goods Administration (TGA) when the volume of a container exceeds 50 mL. If exporting substances derived from human blood, a TGA permit is required regardless of the volume. The application form requires the reason for the request, which can include research purposes. See the G-SpecExport for more details on when export permits are required, and AUS-24 for the application forms.

Other Considerations

The G-TrialsSOP indicates that to ensure the integrity of biological samples has been maintained, there should be evidence of the chain of custody from their point of collection through processing, storage, transport, through to disposal, with evidence of appropriate storage and transit conditions. Equipment used for processing and storage of samples (e.g., centrifuges, fridges, and freezers) should be maintained by suitably qualified persons and periodically inspected, cleaned, and calibrated to the relevant International Organization for Standardization (ISO) standard according to local policy and manufacturer’s manuals. Additionally, the investigator must ensure all study staff, who have cause to handle or ship biological substances, hold a current certificate in the International Air Transport Association (IATA) Approved, Civil Aviation Safety Authority (CASA) Certified Dangerous Goods Packaging Course. The investigator must also ensure that documentation (e.g., receipts, shipping records, order forms, and proformas) related to handling and shipment of biological specimens is maintained and filed in the respective site file.

Additional details on import and export requirements are provided in the G-CTHandbook, the G-TrialsSOP, the G-SpecExport, and AUS-24.

Importing and exporting

Purpose, Determining if You Need a TGA Export Permit, and Applying for a TGA Export Permit

SOP 10

Section 3 (Chapter 3.2)

Last content review/update: November 27, 2024

Import/Export

In accordance with the G-EthicalEval, the transfer of data or biological samples to a third party requires the consent of the researcher, the participant concerned, and the community. If the data or biological samples are transferred abroad, the applicable authorities often need to be given the Materials Transfer Agreement.

Guideline 33

Consent for Specimen