Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Import & Export
Consent for Specimens
Australia
QUICK FACTS
Clinical trial application languageEnglish
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredNo
In-country sponsor presence/representation requiredYes
Age of minorsUnder 18
Specimens export allowedYes
Regulatory Authority > Regulatory Authority
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SUMMARY
Overview
As per the AustraliaTGAct, the AustraliaTGR, the G-AustraliaCTHandbook, and Additional Resources (A) and (B), the Therapeutic Goods Administration (TGA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Australia. The TGA grants exemptions for the supply of unapproved therapeutic goods to be used in clinical trials in accordance with the provisions in the AustraliaTGAct and the AustraliaTGR. There are two (2) regulatory schemes for supplying unapproved therapeutic goods in clinical investigations, which are more fully examined in the Regulatory Authority topic, Scope of Assessment subtopic.
 
As per Additional Resources (A), (C), and (D), the TGA is part of the Health Products Regulation Group (HPRG) within the Australian Department of Health. According to Additional Resources (E) and (F), the TGA regulates the supply, import, export, manufacturing, and advertising of therapeutic goods—prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood, and blood products. In addition, per the AustraliaTGAct, the TGA manages the Australian Register of Therapeutic Goods (ARTG) for all therapeutic goods for human use, and it grants exemptions from the ARTG for unapproved therapeutic goods to be used in clinical trials.
 
Contact Information
Pharmacovigilance and Special Access Branch
Medicines Regulation Division
Therapeutic Goods Administration
 
Postal Address:
P.O. Box 100
Woden ACT 2606
Australia
 
Street Address (for deliveries):
136 Narrabundah Lane
Symonston ACT 2609
Australia
 
Phone:  +61 2 6232 8106
Fax:  +61 2 6232 8112
 
See Additional Resource (G) for additional contact details.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials At a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(C) (Website) About the TGA –Structure (Last Updated March 7, 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(D) (Website) Health Products Regulation Group (Last Updated June 20, 2016)
Department of Health, Australian Government
 
(E) (Website) About the TGA – Who We Are & What We Do (Current as of April 4, 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(F) (Website) About the TGA – What the TGA Regulates (Current as of April 4, 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(G) (Website) TGA – Clinical Trials (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Contact details for enquiries about clinical trials in Australia
 
(H) (Website) Australian Register of Therapeutic Goods (Last Updated April 21, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 1 (3), Chapter 2 (9A), Chapter 3 (Part 3‑2 (18, 19, 31A, and 31B))
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 1 (2A), Part 2C, Part 3 (12AA-12AD), and Schedule 5A
 
(3) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: About the TGA, Foreword, and Introduction
 
 
Regulatory Authority > Scope of Assessment
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SUMMARY
Overview
In accordance with the AustraliaTGAct, the AustraliaTGR, the G-AustraliaCTHandbook, and Additional Resources (A) and (B), the Therapeutic Goods Administration (TGA) is responsible for granting an exemption for the supply of unapproved therapeutic goods to be used in clinical trials under two (2) regulatory schemes—the Clinical Trial Notification (CTN) Scheme, which is a notification process, and the Clinical Trial Exemption (CTX) Scheme, which is an approval process. Under either regulatory scheme, an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve the protocol. The G-AustraliaUnapprovedTGs specifies that the scope of the TGA’s assessment includes all trials (Phases I-IV).
 
Clinical Trial Review Process
Per the G-AustraliaUnapprovedTGs, the sponsor is responsible for determining whether the CTN or CTX scheme should be used. The sponsor may seek advice from the EC in making the determination.
 
CTN Scheme
As per the AustraliaTGAct, the AustraliaTGR, and the G-AustraliaUnapprovedTGs, under the CTN scheme, the TGA is notified of a clinical trial that the EC and the host institution (Approving Authority in Australia) have reviewed and approved. As indicated in Additional Resource (C), sponsors may submit the CTN to TGA concurrently with the EC and host institution’s review and approval. Per the sponsor’s request, the researcher must submit all trial material directly to the EC, which may occur parallel to submitting the CTN form to TGA. The TGA does not assess any data relating to the CTN.
 
The AustraliaCTHandbook states that the TGA is responsible for ensuring that the submitted CTN form is accurate and complete. The TGA reviews all new trial notifications on a weekly basis and may request additional information if the trial raises any concern. Further, CTN trials cannot commence until the TGA has been notified of the trial, approvals received from the EC and host institution, and the appropriate notification fee paid. According to Additional Resource (D), as of July 1, 2015, the TGA transitioned to an online form for CTN submissions. Additional Resources (C), (D), and (E) provide details on using and submitting the online form. In addition, per Additional Resource (C), as of March 1, 2017, the TGA will no longer send an acknowledgement letter by email since this information is available for viewing and printing via the online portal. The TGA advises clinical trial sponsors to obtain and save a print-out of notification at each stage of the submission process.
 
(For additional requirements, see the Clinical Trial Lifecycle topic, Submission Process, Submission Content, Timeline of Review, and Trial Initiation subtopics.)
 
CTX Scheme
Pursuant to the AustraliaTGAct, the AustraliaTGR, the G-AustraliaUnapprovedTGs, and Additional Resource (A), the CTX scheme consists of a two-part approval process. Part 1 constitutes the formal CTX application, which the sponsor completes and submits directly to the TGA. Under Part 1, the TGA reviews the safety of the product. Part 2 requires the sponsor to notify the TGA when a trial commences under the CTX as well as alerting the TGA to new sites in ongoing CTX trials. As described in the G-AustraliaUnapprovedTGs, the EC and the host institution (Approving Authority in Australia) may assess and approve the proposed clinical trial protocol in parallel with the TGA’s review.
 
As delineated in the G-AustraliaUnapprovedTGs and Additional Resource (A), under Part 1, a TGA delegate designated by the Australian Department of Health Secretary reviews and comments on the unapproved therapeutic good or investigational product (IP) information provided by the sponsor during a 30- or 50-day review period depending on the level of review. (Please see Clinical Trial Lifecycle topic, Timeline of Review subtopic for more details on timing). He/she then decides whether to object to the proposed IP guidelines (called the proposed Usage Guidelines by the TGA). If an objection is raised, the trial may not proceed until the delegate withdraws his/her objection. If no objection is raised, the sponsor may conduct the trial without further TGA assessment.
 
However, even if no objection is raised, the TGA provides comments to the sponsor on the accuracy or interpretation of the IP guideline. The trial cannot commence until 1) the sponsor has received written advice from the TGA, 2) the EC and host institution have approved the protocol; and 3) the appropriate TGA fee has been paid (see Regulatory Authority topic, Regulatory Fees subtopic).
 
Per the G-AustraliaUnapprovedTGs, the TGA must receive the sponsor’s notification of EC and host institution approvals within 28 days of commencing to supply the IP, using the CTX Part 2 form.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Do I need to submit a CTN or a CTX?
 
(D) (Website) CTN Scheme Forms (Last Updated September 8, 2015)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(E) (Website) Using the Online CTN Form (Last Updated August 23, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Submitting the Notification
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part 3‑2 (18, 19,
31A, and 31B))
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 1 (2A), Part 2C, Part 3 (12 and 12AA-12AD), and Schedule 5A
 
(3) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: About the TGA, Foreword, and Introduction
 
(4) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 1. Introduction and 2. Clinical Trials—Clinical Trial Notification (CTN) Scheme and The Clinical Trial Exemption (CTX) Scheme
 
Regulatory Authority > Regulatory Fees
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SUMMARY
Overview
As per the G-AustraliaUnapprovedTGs, the sponsor is responsible for paying a fee to the Therapeutic Goods Administration (TGA) to submit a clinical trial notification (CTN) or a clinical trial exemption (CTX) for evaluation. Per Additional Resource (A), the fees are as follows:
 
  • $345 AUD for prescription medicine, biological, and other listed and registered therapeutic goods CTN
  • $1,665 AUD for prescription medicine CTX for 30-day evaluation
  • 20,800 AUD for prescription medicine CTX for 50-day evaluation
  • $25,200 AUD for biological CTX
According to Additional Resource (B), applications for clinical trials under the CTX scheme cost more than notifications under the CTN scheme because of the increased work needed to evaluate the CTX application data. A single fee for CTX includes both Parts 1 and 2. Certain variations to an existing CTN may incur a fee, such as the addition of a new site, change to a previously notified therapeutic good that creates separate and distinct goods, or the addition of a new therapeutic good to a previously notified trial. For additional fee information, refer to Schedule 9 of the AustraliaTGR and the G-AusFeesCharges.
 
Instructions for Payment of CTN and CTX Fees
As stated in Additional Resource (C), payment is made via the TGA Online Payment Portal (Additional Resource (D)). Once the payment has been finalized, the Portal will confirm that payment has been successful and the user may request an email confirmation.
 
ADDITIONAL RESOURCES
(A) (Website) Fees and Charges: Summary - From 1 July 2017 - Prescription Medicines (Version 1.4) (Last Updated February 8, 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Clinical trials: prescription medicines
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: What are the TGA costs related to clinical trials?
 
(C) (Website) Information and Notices about TGA Fees and Payments (Current as of April 4, 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(D) (Website) TGA Online Payment Portal (Current as of April 4, 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
REQUIREMENTS
(1) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: The CTN Scheme and The CTX Scheme
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Section: Schedule 9
 
(3) (Guidance) Fees and charges: summary – From 1 July 2016 (Version 1.4) (G-AusFeesCharges) (February 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Prescription Medicines and Biologicals
 
 
Ethics Committee > Ethics Committee
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SUMMARY
Overview
As indicated in the AustraliaTGAct, the AustraliaTGR, the G-AustraliaCTHandbook, the G-AusNatlStmt, and Additional Resources (A) and (B), Australia has a decentralized process for the ethics review and approval of clinical trial research. Australia requires clinical trial approval from an institutional-level ethics committee (EC). Per the AustraliaTGAct, ECs are required to be constituted and operating in accordance with the guidelines issued by the National Health and Medical Research Council (NHMRC) and to have notified NHMRC of their existence. The NHMRC was established by the NHMRCAct. Per Additional Resource (A), all materials relating to a proposed clinical trial, including the trial protocol, are submitted to the EC by researchers at the sponsor’s request. (Note: Institutional ECs are referred to as Human Research Ethics Committees (HRECs) in Australia.)
 
As per the AustraliaTGR, the G-AusNatlStmt, the G-AusSafetyMonitoring_Reporting, and Additional Resource (D), institutional ECs ensure that clinical trial research complies with the NHMRC’s ethical standards published in the G-AusNatlStAmt.
 
As stated in the AustraliaTGAct, the AustraliaTGR, the G-AusSafetyMonitoring_Reporting, the G-AustraliaCTHandbook, and Additional Resource (E), the NHMRC is responsible for receiving EC registrations. Per Additional Resource (F), NHMRC also maintains a National Certification Scheme for institutional ethics review processes. For more information on the NHMRC registration and certification process, see the Ethics Committee topic, Authorizing Body subtopic.
 
EC Composition
As stated in the G-AusNatlStmt, an EC must be composed of at least eight (8) members representing, to the extent possible, equal numbers of men and women, one third of which are from outside the institution. Specifically, the EC composition should include:
  • A chairperson
  • At least two (2) lay persons, one (1) man and one (1) woman, who have no affiliation with the institution and are not currently involved in medical, science, legal, or academic work
  • At least one (1) person with knowledge of and current experience in the medical profession, counseling, and/or treatment of people
  • At least one (1) person who performs a pastoral care role in the community
  • At least one (1) lawyer
  • At least two (2) people with current research experience relevant to the research proposals under consideration by the EC
ECs may also include other members with additional areas of expertise.
 
Terms of Reference, Review Procedures, and Meeting Schedule
As delineated in the G-AusNatlStmt, institutional ECs must establish and follow procedures to promote good ethics reviews. The procedures should address:
  • Meeting frequency, attendance, conduct, and structure
  • Minutes and agenda preparation
  • Timely distribution of materials before meetings
  • Presentation of applications for ethics review
  • Frequency of EC reviews
  • Management of conflicts of interest
  • Modes of communicating with researchers
  • Institutional reporting
  • Decision-making methods
  • Prompt notification of decisions, including withdrawals of approval
  • Record keeping
  • Monitoring of approved research
  • Reporting and handling of adverse events
  • Receiving and handling of complaints
  • Fees, if any
  • Confidentiality of applications and associated reviews
Pursuant to the G-AusNatlStmt, EC members should be familiar with the G-AusNatlStmt and other relevant guidelines; prepare for and attend EC meetings or, if unavailable, provide opinions before the meetings; and attend research ethics training at least every three (3) years. ECs must communicate their decisions in writing with reasons substantiated by the G-AusNatlStmt, and they should maintain a record of all research proposals and decisions in written or electronic form. For more detail on the governance and responsibilities of Australian institutional ECs, see the G-AusNatlStmt.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials At a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(C) (Website) Human Research Ethics Committees (Last Updated February 14, 2017)
National Health and Medical Research Council, Australian Government
 
(D) (Website) FAQs about Human Research Ethics Committees (Last Updated July 7, 2015)
National Health and Medical Research Council, Australian Government
 
Relevant Section: Why Should You Register Your HREC with NHMRC?
 
(E) (Website) National Approach to Single Ethical Review of Multi-Centre Research (Last Updated November 18, 2016)
National Health and Medical Research Council, Australian Government
 
Relevant Section: National Certification Scheme
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 1 (3) and Chapter 3 (Part 3‑2 (18 and 19))
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12AA and 12AD)
 
(3) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Foreword and Introduction
 
(4) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Section 3 (3.3), and Section 5 (5.1 and 5.2)
 
(5) (Guidance) Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (G-AusSafetyMonitoring_Reporting) (November 2016)
National Health and Medical Research Council, Department of Health, Australian Government
 
Relevant Section: Part 1 (C.3)
 
(6) (Legislation) National Health and Medical Research Council Act 1992 (No. 225, 1992 as amended) (NHMRCAct) (Amended July 1, 2014)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Section: Part 1 (3), Part 2 (5B, 5C)
 
Ethics Committee > Scope of Review
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SUMMARY
Overview
According to the G-AusNatlStmt, the primary scope of information assessed by the institutional ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) relates to protecting the interests of research participants by ensuring adherence to the values of respect, research merit and integrity, justice, and beneficence throughout the conduct of the research project. The EC must pay special attention to reviewing the recruitment and consent processes and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates; Prisoners; and Mentally Impaired for additional information about these populations).
 
Pursuant to the G-AusNatlStmt, the EC is responsible for conducting a competent review of all ethical aspects of the protocol, evaluating possible risks and expected benefits to participants, confirming the suitability of the researcher(s), facilities, and methods, and verifying the adequacy of confidentiality safeguards.
 
Role in Clinical Trial Approval Process
In accordance with the G-AusNatlStmt, and Additional Resources (B) and (C), ECs are responsible for reviewing and approving protocols under one (1) of two (2) regulatory schemes—the Clinical Trial Notification (CTN) Scheme or the Clinical Trial Exemption (CTX) Scheme—prior to the sponsor initiating a trial. Per the G-AustraliaUnapprovedTGs, the sponsor determines whether to submit the clinical trial application as a CTN or CTX scheme. As per the AustraliaTGR, the G-AustraliaUnapprovedTGs, and Additional Resources (B) and (C), the two (2) regulatory review schemes are described as follows:
  • CTN scheme - According to the G-AustraliaUnapprovedTGs, a CTN trial must be notified to the TGA before it can commence and the review and approval by an EC may be conducted parallel to this submission. The EC provides scientific and ethical review and notifies the sponsor of approval.
  • CTX scheme - The TGA reviews and comments on the unapproved therapeutic good or investigational product (IP) information and must approve the clinical trial application before the sponsor can initiate the trial. The TGA’s review covers the safety of the product—not the protocol, which is the EC’s domain. The EC review and approval of the clinical trial protocol is required and may occur in parallel with the TGA’s review and approval, although, in practice, the EC usually awaits TGA approval prior to commencing its review. The host institution (Approving Authority in Australia), which is responsible for providing authorization for the project at its site(s), may conduct its oversight, including site assessment, simultaneously with the EC and the TGA.
While each EC has its own required submission procedures, Additional Resource (D) indicates that the National Health and Medical Research Council (NHMRC) developed the Human Research Ethics Application (HREA) for submitting proposals to ECs. The HREA is an online tool designed to ensure national consistency in information submitted for ethics review. Use of the application is voluntary but may be required at an institution’s discretion.
 
For both schemes, the AustraliaTGR requires that the EC ensure that trials comply with the G-AusNatlStmt and the Good Clinical Practice as adopted by Australia in the G-AustraliaGCP, which implements the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and includes annotations by TGA. Pursuant to the G-AustraliaUnapprovedTGs and the AustraliaTGR, when the EC approves a trial protocol, it takes responsibility for monitoring the progress and conduct of the trial. 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 trials-related matters.
 
As per Additional Resource (E), if a multicenter trial is being conducted and if the project has been reviewed by an EC affiliated with a certified institution, other participating institutions may choose to accept the review of this EC; however, site assessment at each participating institution must still take place. Many multicenter clinical trials are also subject to the requirements of the National Mutual Acceptance scheme operated by a cohort of Australian states and territories for research conducted in the publicly funded health sector. For more information on this approach, see Additional Resource (E).
 
ADDITIONAL RESOURCES
(A) (Website) Human Research Ethics Committees (Last Updated February 14, 2017)
National Health and Medical Research Council, Australian Government
 
(B) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(C) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(D) (Website) Human Research Ethics Application (Current as of April 4, 2017)
National Health and Medical Research Council, Australian Government
 
(E) (Website) National Approach to Single Ethical Review of Multi-Centre Research (Last Updated November 18, 2016)
National Health and Medical Research Council, Australian Government
 
Relevant Section: National Certification Scheme
 
International Conference on Harmonisation
Geneva, Switzerland
 
REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Preamble, Purpose, Scope and Limits of this Document, 1, 2, 4, and 5
 
(2) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 3
 
(3) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12 and 12AA-12AD) ) and Schedule 5A
 
(4) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 1. Introduction and 2. Clinical Trials—Clinical Trial Notification (CTN) Scheme and The Clinical Trial Exemption (CTX) Scheme
 
Ethics Committee > Ethics Committee Fees
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SUMMARY
Overview
According to Additional Resource (A), ethics committees (ECs) (Human Research Ethics Committee (HREC) in Australia) routinely charge a fee for ethics review of commercial research. Additional Resource (B) further states that institutions that agree to provide ethics reviews on behalf of an external institution or an independent researcher may also levy a fee for this service.
 
As per the G-AusNatlStmt, institutions that individually or jointly establish ECs should allocate adequate funds to prevent charging fees for ethics reviews in amounts that would discourage research that the institution has an obligation to support (e.g., non-commercial research). The institutional budget should also enable the EC to achieve the following:
  • Satisfy the requirements for a sound ethics review
  • Communicate with researchers

 

ADDITIONAL RESOURCES
(A) (Website) Human Research Ethics Committees (Last Updated February 14, 2017)
National Health and Medical Research Council, Australian Government
 
(B) (Website) FAQs about Human Research Ethics Committees (Last Updated July 7, 2015)
National Health and Medical Research Council, Australian Government
 
Relevant Section: When Do You Need to Establish an HREC?
 
REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: 5
 
Ethics Committee > Authorizing Body
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SUMMARY
Overview
As per the AustraliaTGAct, the G-AusNatlStmt, and the G-AustraliaCTHandbook, and Additional Resource (A), the National Health and Medical Research Council (NHMRC) is responsible for registering ethics committees (ECs) (Human Research Ethics Committee (HREC) in Australia). The NHMRC was established by the NHMRCAct. According to the G-AustraliaCTHandbook, a clinical trial cannot commence until it is approved by an EC. In addition, as per Additional Resource (B), the NHMRC administers a voluntary certification program for ECs to conduct an ethics review of multicenter research.
 
Notification
As specified in Additional Resources (C) and (D), institutions can register their ECs, notify of changes to ECs, or terminate EC notifications by submitting the appropriate forms to the NHMRC. These forms should be saved electronically and then completed and emailed to ethics@nhmrc.gov.au. According to Additional Resource (E), registered ECs should report annually to the NHMRC on their compliance with the G-AusNatlStmt. The NHMRC assesses the annual reports and notifies the EC of the outcome of its assessment or requests clarifying information.
 
Certification
As per Additional Resource (B), the NHMRC is the certifying body for Australia’s national, voluntary certification of ECs for multicenter research. As delineated in Additional Resource (F), following the institution’s self-assessment of its EC, it applies for certification to the NHMRC by emailing its completed Self-Assessment, Nomination Form, Declaration Form, and Checklist, along with mandatory supporting documentation, to ethics@nhmrc.gov.au with "DOCUMENTATION FOR CERTIFICATION" in the subject line. The NHMRC then conducts a desktop assessment and an on-site visit. The NHMRC approves certification if the EC can facilitate a single ethics review and meets the requirements delineated in the G-AusNatlStmt. For a current list of certified ECs, see Additional Resource (F). For assistance or additional information regarding certification, email NHMRC at ethics@nhmrc.gov.au.
 
ADDITIONAL RESOURCES
(A) (Website) FAQs about Human Research Ethics Committees (Last Updated July 7, 2015)
National Health and Medical Research Council, Australian Government
 
Relevant Section: Why Should You Register Your HREC with NHMRC?
 
(B) (Website) National Approach to Single Ethical Review of Multi-Centre Research (Last Updated November 18, 2016)
National Health and Medical Research Council, Australian Government
 
Relevant Section: National Certification Scheme
 
(C) (Website) Registering or Closing an HREC (Last Updated July 17, 2015)
National Health and Medical Research Council, Australian Government
 
(D) (Website) HREC Forms (Last Updated July 7, 2015)
National Health and Medical Research Council, Australian Government
 
(E) (Website) HREC and Certified Institution Annual Reporting to NHMRC (Last Updated March 16, 2017)
National Health and Medical Research Council, Australian Government
 
(F) (Website) How to Apply for Certification (Last Updated November 18, 2016)
National Health and Medical Research Council, Australian Government
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016) Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Section: Chapter 1 (3)
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: 5
 
(3) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Introduction
 
(4) (Legislation) National Health and Medical Research Council Act 1992 (No. 225, 1992 as amended) (NHMRCAct) (Amended July 1, 2014)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Section: Part 1 (3), Part 2 (5B, 5C)
 
Clinical Trial Lifecycle > Submission Process
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SUMMARY
Overview
In accordance with the AustraliaTGAct, the AustraliaTGR, the G-AustraliaUnapprovedTGs, and Additional Resources (A) and (B), Australia requires the sponsor to obtain clinical trial authorization, referred to as a “legal exemption,” from the Therapeutic Goods Administration (TGA) for the supply of unapproved therapeutic goods for clinical trials. The sponsor can apply under two (2) regulatory schemes—the Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme. Per the G-AustraliaUnapprovedTGs and Additional Resource (A), the sponsor is responsible for determining whether the CTN or CTX scheme should be used; the sponsor may seek advice from the ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia). Under either regulatory scheme, an EC must approve the protocol, which may occur in parallel with the TGA’s review.
 
While each EC has its own required submission procedures, Additional Resource (C) indicates that the National Health and Medical Research Council (NHMRC) developed the voluntary Human Research Ethics Application (HREA) for submitting proposals to ECs. The voluntary HREA, which may be required at an institution’s discretion, is an online tool designed to ensure national consistency in information submitted for ethics reviews.
 
Delivery Information for Clinical Trial Application
CTN Scheme
As per Additional Resources (A) and (D), at the sponsor’s request, the researcher submits the trial protocol and all related material directly to the EC for review and approval. The sponsor may submit the CTN form simultaneously while obtaining the necessary endorsements. It is the responsibility of the sponsor to ensure that all relevant approvals are in place before supplying the therapeutic goods in the clinical trial.
 
CTX Scheme
As delineated in Additional Resources (A), (F), and (G), there are two (2) submission processes (called Parts) under the CTX Scheme. Per Additional Resource (H), the TGA no longer accepts hard copies of the CTX application. Parts 1 and 2 of the CTX application should be submitted in electronic format.
 
 
Postal Address (for USB or CDs):
The Clinical Trials Officer
Experimental Products Section
Pharmacovigilance and Special Access Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Phone: 1800.020.653
Fax: 02.6203.1605
 
Assembly and Number of Copies
As indicated in Additional Resources (A) and (J), to submit a CTN or CTX application, a sponsor must have a TGA Client Identification Number, which is obtained by applying to the TGA Business Services.
 
CTN Scheme
According to Additional Resource (D), as of July 1, 2015, the TGA transitioned to an online form for CTN submissions. Additional Resources (D), (E), and (I) provide details on using and submitting the online form. As per Additional Resource (H), to successfully submit the online CTN form, the sponsor must accept a declaration to assume responsibility for the trial. According to Additional Resource (E), as of March 1, 2017, the TGA will no longer send an acknowledgement letter by email since this information is available for viewing and printing via the online portal. The TGA advises clinical trial sponsors to obtain and save a print-out of notification at each stage of the submission process.
 
CTX Scheme
As per Additional Resource (H), CTX Parts 1 and 2 applications should be submitted to the TGA in electronic format either via email, on a USB stick, or CD. TGA recommends that sponsors send supporting data for Part 1 via USB or CD as the data packages are usually large and unable to be successfully transmitted on email. Pursuant to the G-AustraliaUnapprovedTGs and Additional Resource (G), the sponsor submits the CTX Part 2 form to the TGA within 28 days of commencing the supply of goods at each site.
 
Clinical Trial Application Language Requirements
The G-AustraliaUnapprovedTGs states all applications and supporting data submitted to the TGA are required to be in English.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(C) (Website) Human Research Ethics Application (Current as of April 4, 2017)
National Health and Medical Research Council, Australian Research Council, Australian Government
 
(D) (Website) CTN Scheme Forms (Last Updated September 8, 2015)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Will original signatures be required on the online CTN form? Do I need to submit a CTN or a CTX? I have submitted an online CTN form. Will I get a TGA acknowledgement letter?
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
(H) NIAID Communication with Australia Therapeutic Goods Administration (not available online) (February 2017)
 
(I) (Website) Using the Online CTN Form (Last Updated August 23, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Submitting the Notification
 
(J) (Website) TGA Business Services: Getting Started with the TGA (Last Updated October 25, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part 3-2 (18, 19, 31A, and 31B))
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12 and 12AA-12AD) and Schedule 5A
 
(3) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Clinical Trials - Clinical Trial Notification (CTN) Scheme, The Clinical Trial Exemption (CTX) Scheme, Appendix 2, and Appendix 4
 
Clinical Trial Lifecycle > Submission Content
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SUMMARY
Overview
In accordance with the AustraliaTGAct, the AustraliaTGR, the G-AustraliaUnapprovedTGs, and Additional Resources (A) and (B), the Therapeutic Goods Administration (TGA) requires the sponsor to either notify or apply for clinical trial authorization for the supply of unapproved therapeutic goods for clinical trials. Under either the Clinical Trial Notification (CTN) Scheme or the Clinical Trial Exemption (CTX) Scheme, the investigator, at the request of the sponsor, submits the trial protocol to an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) for approval, which under the CTX scheme may occur in parallel with the TGA’s review. The CTN scheme does not require TGA review. See the Regulatory Authority topic, Scope of Assessment subtopic for detailed review and approval process information.
 
TGA Requirements
CTN Scheme
As delineated in Additional Resources (C), (D), and (E), the following documentation must be submitted to the TGA in the CTN online notification form:
  • Sponsor name and address
  • Sponsor declaration
  • Notification fee (See Regulatory Authority topic, Regulatory Fees subtopic)
  • Investigator’s contact information
  • Protocol number
  • Expected trial start and completion dates
  • Potential use of restricted goods
  • Study title
  • 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
  • EC name and contact information
CTX Scheme
As per the G-AustraliaUnapprovedTGs, the TGA reviews the safety of the product—not the protocol, which is the EC’s domain. The EC review and approval of the clinical trial protocol is required and may occur in parallel with the TGA’s review and approval. As specified in the G-AustraliaUnapprovedTGs and Additional Resource (F), the following documentation for Part 1 of the CTX application must be submitted to the TGA:
  • Sponsor name
  • Cover letter
  • CTX form, which includes the required Sponsor Declaration to assume responsibility for the trial
  • IP and trial details
  • Chemical, pharmaceutical, and biological documentation; please note that TGA accepts submission(s) of scientific summaries that comply with the United Kingdom’s CTX Scheme requirements
  • Pharmaco-toxicological documentation
  • Clinical documentation
  • Documentation of fatal or life-threatening adverse events
  • EC summary information, including Usage Guidelines and summary data sheets
As per the G-AustraliaUnapprovedTGs and Additional Resource (G), Part 2 of the CTX clinical trial notification—used to notify the TGA of clinical trial conduct and commencement—should contain:
  • Sponsor name and client ID code
  • IP or biological name
  • CTX number assigned by the TGA to the Part 1 CTA form
  • Indication of whether it is a new site or additional site
  • Trial and site details, including the protocol number and trial start and expected end dates
  • Sponsor certification
  • Host institution certification (known as Approving Authority in Australia)
  • Principal investigator certification
  • EC certification
Institutional EC Requirements
Each institutional EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies to be supplied and application format requirements. However, per the G-AustraliaCTHandbook, at a minimum, the investigator must submit the following documentation to an EC for review and approval:
  • Clinical protocol
  • Investigator’s brochure
  • Informed consent forms
  • Participant information documents
  • Procedures for subject recruitment
  • Payment or compensation
  • Investigator’s qualifications
  • Additional required institutional EC documentation
Additional Resource (H) indicates that the National Health and Medical Research Council (NHMRC) developed the Human Research Ethics Application (HREA) for submitting research proposals to ECs. The HREA, which may be required at an institution’s discretion, is an online tool designed to ensure national consistency in information submitted for ethics reviews. To access the form and create an HREA account, go to the HREA website at https://hrea.gov.au/.
 
Clinical Protocol
As delineated in the G-AustraliaCTHandbook, the clinical protocol should include the following elements:
  • General information
  • Background information
  • Trial objectives and purpose
  • Trial design
  • Participation selection/withdrawal
  • Participant treatment
  • Efficacy assessment
  • Safety assessment
  • Statistics
  • Direct access to source data/documents
  • Quality control/quality assurance procedures
  • Ethical considerations
  • Data handling and record keeping
  • Financial and insurance
  • Supplements
 For complete protocol requirements, see the G-AustraliaCTHandbook.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(C) (Website) CTN Scheme Forms (Last Updated September 8, 2015)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: How do I complete an online CTN form?
 
(E) (Website) Completing the Online CTN Form (Last Updated August 23, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
(H) (Website) Human Research Ethics Application (Current as of April 4, 2017)
National Health and Medical Research Council, Australian Government
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part3-2 (18, 19, 31A, and 31B))
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12 and 12AA-12AD)
 
(3) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Clinical Trials - Clinical Trial Notification (CTN) Scheme, The Clinical Trial Exemption (CTX) Scheme, Appendix 2, and Appendix 4
 
(4) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Human Research Ethics Committees
 
Clinical Trial Lifecycle > Timeline of Review
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SUMMARY
Overview
In accordance with the AustraliaTGAct, the AustraliaTGR, the G-AustraliaUnapprovedTGs, the G-AustraliaCTHandbook, and Additional Resources (A) and (B), the Therapeutic Goods Administration (TGA) is responsible for authorizing for the supply of unapproved therapeutic goods for clinical trials under two (2) regulatory schemes—the Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme. According to the G-AustraliaUnapprovedTGs, a CTN trial must be notified to the TGA before it can commence. The review and approval by an institutional ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) may be conducted in parallel. With regard to CTX trials, as per the AustraliaTGAct, the AustraliaTGR, the G-AustraliaUnapprovedTGs, and Additional Resource (A), the review and approval of a clinical trial application (CTA) by the TGA and an EC may be conducted in parallel. It is the sponsor’s responsibility to ensure that all necessary endorsements are completed before a trial begins.
 
TGA Approval
CTN Scheme
As per the AustraliaTGAct, the AustraliaTGR, and the G-AustraliaUnapprovedTGs, under the CTN scheme the TGA is notified of a clinical trial. The sponsor may submit the CTN form simultaneously while obtaining the necessary endorsements. It is the responsibility of the sponsor to ensure that all relevant approvals are in place before supplying the therapeutic goods in the clinical trial. According to the G-AustraliaCTHandbook, the TGA reviews all new trial notifications on a weekly basis and may request additional information if the trial raises any concern. CTN trials can commence when the trial has been notified to the TGA and the appropriate notification fee paid. Per Additional Resource (B), effective March 1 2017, the TGA no longer sends acknowledgment letters by email as this information can now be viewed and printed via the online portal. The TGA advises clinical trial sponsors to obtain and save a print-out of notification at each stage of the submission process.
 
CTX Scheme
As per the G-AustraliaUnapprovedTGs, the TGA review and approval process under the CTX scheme, which involves the agency’s review of Part 1 of the application, takes 30 working days for CTAs that only deal with chemical, pharmaceutical, and biological issues. For CTAs supported by chemical, pharmaceutical and biological, pharmaco-toxicological, and clinical data, there is a 50-day evaluation period. These evaluation periods commence from the date of acceptance of the application, or, receipt of the appropriate fee, whichever is later. If the TGA does not raise any concerns before the end of the 30- and 50-day periods, the sponsor will receive written notice from the TGA that the trial may commence, provided it has received EC and host institution (also known as the approving authority) approval.
 
As specified in the G-AustraliaUnapprovedTGs, during the review period, the TGA may request additional information from the sponsor, who has 30 working days to provide such information. The TGA has 20 working days to review the sponsor’s additional material. However, if there are significant amounts of new data, the TGA may negotiate a longer review period. The TGA will send a written communication regarding its decision. If the CTA is rejected, the sponsor may appeal TGA’s decision pursuant to the AustraliaTGAct.
 
Ethics Committee Approval
The EC review and approval process timeline varies by institution. However, according to the G-AusNatlStmt, the institutional EC should review a proposed clinical trial and make its decision in a timely manner.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: I have submitted an online CTN form. Will I get a TGA acknowledgement letter?
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part 3-2 (18, 19, 31A, and 31B)) and Chapter 7 (60)
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12 and 12AA-12AD) and Schedule 5A
 
(3) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Clinical Trials - Clinical Trial Notification (CTN) Scheme, The Clinical Trial Exemption (CTX) Scheme, Appendix 2, and Appendix 4
 
(4) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Clinical Trial Monitoring and Inspection, Medicinal Product Trials, On Receipt of CTN Form
 
(5) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 5 (5.1)
 
Clinical Trial Lifecycle > Trial Initiation
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SUMMARY
Overview
In accordance with the AustraliaTGAct, the AustraliaTGR, and the G-AustraliaUnapprovedTGs, and Additional Resource (A), a clinical trial can only commence under the Clinical Trial Notification (CTN) Scheme or the Clinical Trial Exemption (CTX) Scheme.
 
CTN Scheme
The sponsor must notify the Therapeutic Goods Administration (TGA) about the trial through submittal of the online CTN form and pay the appropriate notification fee.
 
CTX Scheme
A sponsor cannot commence a CTX trial until written advice has been received from the TGA regarding the application, and approval for the conduct of the trial has been obtained from an ethics committee (EC) (Human Research Ethics Committees (HRECs) in Australia) and the institution (also called the Approving Authority in Australia) where the trial will be conducted. Sponsors must notify the TGA within 28 days of commencing the supply of goods at each site using the CTX Part 2 form. This notification contains certifications with original signatures for the sponsor, principal investigator (PI), EC, and host institution.
 
According to the G-AustraliaUnapprovedTGs and Additional Resource (C), prior to commencing the clinical trial, the sponsor, PI, EC, and host institution must be satisfied that the conduct of the trial complies with the following requirements:
Clinical Trials Registry
As per Additional Resource (E), prospective clinical trial registration is widely accepted as an essential part of an overall strategy for improving research transparency. In Australia, the Australian New Zealand Clinical Trials Registry (ANZCTR) is one of the primary registries in the World Health Organization Registry Network. Trials may also be registered on any other International Committee of Medical Journals Editors (ICMJE) approved registry.
 
Institutional EC Confirmation of Review and Approval
Additional Resources (B) and (C) require the sponsor to obtain institutional EC approval for each participating site prior to initiating a clinical trial. (See Ethics Committee topic, Scope of Review subtopic for detailed information on the institutional EC review and approval process).
 
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Can I Start the Trial Once I Have Submitted an Online CTN Form?
 
(C) (Website) Good Clinical Practice (GCP) in Australia (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
International Council for Harmonisation
 
Relevant Sections: 4, 5.4, 5.5, and 5.6
 
(E) (Website) Trial Registration (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(F) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(G) (Website) Australian New Zealand Clinical Trials Registry (Current as of April 4, 2017)
National Health and Medical Research Council, Australian Government
 
(H) (Website) The WHO Registry Network (Current as of April 4, 2017)
World Health Organization
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part 3-2 (18, 19, 31A, and 31B))
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12 and 12AA-12AD)
 
(3) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Clinical Trials - Introduction, Good Clinical Practice, The Legislative Basis for Clinical Trials, Clinical Trial Notification (CTN) Scheme, and The Clinical Trial Exemption (CTX) Scheme
 
(4) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 5 (5.1)
 
(5) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Clinical Trial Monitoring and Inspection
 
(6) (Guidance) Note for Guidance on Good Clinical Practice, Annotated with TGA Comments (CPMP/ICH/135/95) (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 1
 
Clinical Trial Lifecycle > Safety Reporting
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SUMMARY
Overview
According to the G-AustraliaUnapprovedTGs, 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 investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment
  • Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions
  • Unexpected Adverse Drug Reaction – An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product)
  • Serious Adverse Drug Reaction (SADR) or Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect
  • Serious, Unexpected ADR – A serious ADR that is not identified in nature or severity in the investigator’s brochure
Reporting Requirements for AEs/ADRs
Sponsor Responsibilities
As delineated in the G-AustraliaSafetyDataMgt, the G-AustraliaUnapprovedTGs, and the G-AustraliaCTHandbook, the sponsor is required to expedite reports of serious and unexpected AEs/ADRs to the Therapeutic Goods Administration (TGA). Australia has adopted expedited reporting requirements that are delineated in the G-AustraliaGCP.
 
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. This expedited reporting requires the sponsor to file reports in the following specified timelines:
  • When the AE/ADR is neither fatal nor life-threatening, within 15 days after becoming aware of the information
  • When it is fatal or life-threatening, an initial or full report within seven (7) calendar days and a follow-up report, if necessary, within 15 calendar days
  • Within eight (8) days after having informed TGA of the AE/ADR, submit a complete report
The G-AustraliaCTHandbook further requires the sponsor to maintain AE/ADR reports per the trial protocol and submit them to the TGA upon request. The G-AustraliaSafetyDataMgt indicates that the TGA does not require sponsors to submit individual overseas reports of suspected ADRs. The sponsor should continually monitor the safety of its clinical program and advise the TGA within 72 hours of any significant issue that has arisen from its analysis of overseas reports or action that has been taken by another country's regulatory agency.
 
Investigator Responsibilities
As specified in the G-AustraliaCTHandbook, the investigator must inform the sponsor and the ethics committee (EC) of all SAEs/SADRs, followed promptly by a detailed written report. Further, the investigator must report to the sponsor and EC the AEs/ADRs and/or laboratory abnormalities that are critical to safety within the time specified in the protocol. For reported deaths, the investigator should supply the sponsor and the EC with any additional requested information.
 
Form Completion and Delivery
As per the G-AustraliaSafetyDataMgt, all serious and unexpected AEs/ADRs must be reported to the TGA using a form (tabular or narrative format) that has the key data elements identified in Attachment 1 of the G-AustraliaSafetyDataMgt. The sponsor can also use the CIOMS Form for reporting. Per Additional Resource (A), the report should be submitted via the TGA Business Services Online Portal (preferred) or forwarded to the Pharmacovigilance and Special Access Branch of the TGA by email to adr.reports@health.gov.au.
 
Data Safety and Monitoring Board
Although not specified as a sponsor requirement, the G-AustraliaGCP states that a Data Safety and Monitoring Board (DSMB) (known as an Independent Data-Monitoring Committee in Australia) may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. The DSMB should have written standard operating procedures (SOPs) and maintain written records of all its meetings.
 
ADDITIONAL RESOURCES
(A) NIAID Communication with Australia Therapeutic Goods Administration (not available online) (March 2017)
 
Council for International Organizations of Medical Sciences, Geneva, Switzerland
 
REQUIREMENTS
(1) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Reporting of Adverse Reactions Arising During Clinical Trials of Medicines, and Appendix 7 ADRAC Blue Card format
 
(2) (Guidance) Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95), Annotated with TGA Comments (G-AustraliaSafetyDataMgt) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Introduction and Definitions and Terminology Associated with Clinical Safety Experience, How to Report, and Attachment 1
 
(3) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Managing Adverse Events and Adverse Drug Reactions
 
(4) (Guidance) Note for Guidance on Good Clinical Practice, Annotated with TGA Comments (CPMP/ICH/135/95) (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 1
 
Clinical Trial Lifecycle > Progress Reporting
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SUMMARY
Overview
As per the G-AustraliaGCP, the G-AusNatlStmt, and the G-AustraliaCTHandbook, the investigator(s) is responsible for submitting progress reports to the sponsor and ethics committee (EC) (known as Human Research Ethics Committee in Australia) annually, or more frequently if requested. If there are significant changes in trial conduct or safety, the investigator should submit a written report to the sponsor and the EC. The investigator should provide the EC with a final clinical study report. Pursuant to Additional Resource (A), the sponsor should make the final report available to the Therapeutic Goods Administration (TGA) upon request. If requested, the report should be provided electronically, via email, USB, or CD in any format the sponsor chooses.
 
ADDITIONAL RESOURCES
(A) NIAID Communication with Australia Therapeutic Goods Administration (not available online) (February 2017)
 
REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice, Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 4
 
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Last updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 5 (5.5)
 
(3) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Trial Documentation, The Essentials
 
Sponsorship > Definition of Sponsor
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SUMMARY
Overview
As per the G-AustraliaGCP, the G-AustraliaUnapprovedTGs, and the G-AustraliaCTHandbook, 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 G-AustraliaGCP (which is Australia’s implementation of the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs)), Australia permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities to be transferred to a CRO should be specified in a written agreement. Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
 
According to the G-AustraliaUnapprovedTGs, if the investigator initiates and organizes the trial, he or she is to be defined as the sponsor of the trial and will be responsible for the sponsor’s functions. This includes where another party (usually a pharmaceutical company) provides the medicinal product used in the clinical trial but has no other involvement in the conduct of the trial.
 
As per the G-AustraliaUnapprovedTGs, the G-AustraliaCTHandbook, and Additional Resources (A), (B), and (C) a sponsor must be an Australian entity.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials - Sponsorship (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Who can sponsor a clinical trial? and Does the sponsor of a clinical trial in Australia have to be an Australian entity?
 
International Conference on Harmonisation, Geneva, Switzerland
 
REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 1 and 5
 
(2) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Appendix 1 Glossary
 
(3) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Sponsor
 
Sponsorship > Trial Authorization
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SUMMARY
Overview
In accordance with the AustraliaTGAct, the AustraliaTGR, the G-AustraliaUnapprovedTGs, and Additional Resources (A) and (B), the sponsor either notifies or applies for clinical trial authorization for the supply of unapproved therapeutic goods for clinical trials to the Therapeutic Goods Administration (TGA). These two (2) regulatory schemes are known as the Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme, respectively. Per the G-AustraliaUnapprovedTGs and Additional Resources (A) and (C), the sponsor, followed by the ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia), is responsible for determining whether the CTN or CTX Scheme should be used. Under either regulatory scheme, an EC must approve the protocol, which under the CTX Scheme may occur in parallel with the TGA’s review. The CTN Scheme does not require TGA review.
 
CTN Scheme
Under the CTN Scheme, Additional Resource (C) indicates that the trial must be approved by the sponsor of the goods and the sponsor of the trial (if not the sponsor of the goods) having regard for the advice of the EC, which reviewed the protocol and is assuming responsibility for the monitoring of the trial. Furthermore, the terms of approval of the sponsor must be no less restrictive than terms advised by the EC.
 
As delineated in Additional Resources (C), (D), and (E), the sponsor must submit the following documentation to the TGA in the CTN online notification form:
  • Sponsor name and address
  • Sponsor declaration
  • Notification fee (See Regulatory Authority topic, Regulatory Fees subtopic)
  • Investigator’s contact information
  • Protocol number
  • Expected trial start and completion dates
  • Potential use of restricted goods
  • Study title
  • Trial phase and brief description
  • 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
  • EC name and contact information
CTX Scheme
As per the G-AustraliaUnapprovedTGs, the TGA reviews the safety of the product. The EC review and approval of the clinical trial protocol is required and may occur in parallel with the TGA’s review and approval. As specified in the G-AustraliaUnapprovedTGs and Additional Resource (F), the sponsor must submit the following documentation for Part 1 of the CTX application to the TGA:
  • Sponsor name
  • Cover letter
  • CTX form, which includes the required Sponsor Declaration to assume responsibility for the trial
  • IP and trial details
  • Chemical, pharmaceutical, and biological documentation; please note that TGA accepts submission(s) of scientific summaries that comply with the United Kingdom’s CTX Scheme requirements
  • Pharmaco-toxicological documentation
  • Clinical documentation
  • Documentation of fatal or life-threatening adverse events
  • EC summary information, including Usage Guidelines and summary data sheets
As per the G-AustraliaUnapprovedTGs and Additional Resource (G), the sponsor must submit Part 2 of the CTX clinical trial notification—used to notify the TGA of clinical trial conduct and commencement—which should contain:
  • Sponsor name and client ID code
  • IP or biological name
  • CTX number assigned by the TGA in the Part 1 CTA form
  • Indication of whether it is a new site or additional site
  • Trial and site details, including the protocol number and trial start and expected end dates
  • Sponsor certification
  • Host institution certification (known as Approving Authority in Australia)
  • Principal investigator certification
  • EC certification
As indicated in Additional Resources (A) and (H), to submit a CTN or CTX application, a sponsor must have a TGA Client Identification Number, which is obtained by applying to the TGA Business Services.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of April 4, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Do I need to submit a CTN or a CTX form? and How do I complete an online CTN form?
 
(D) (Website) CTN Scheme Forms – Clinical Trials (Last Updated September 8, 2015)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(E) (Website) Completing the Online CTN Form (Last Updated August 23, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
(H) (Website) TGA Business Services: Getting Started with the TGA (Last Updated October 25, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct(Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part 3-2 (18, 19, 31A, and 31B)) and Schedule 5
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12 and 12AA-12AD) and Schedule 5A
 
(3) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Clinical Trials - Introduction, Clinical Trial Notification (CTN) Scheme, and The Clinical Trial Exemption (CTX) Scheme
 
Sponsorship > Insurance
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SUMMARY
Overview
The AustraliaTGR directs the sponsor to comply with the requirements in the G-AustraliaGCP and the G-AusNatlStmt, which, in turn, mandate insurance coverage in the event of a trial-related injury and to provide insurance for the trial investigator(s). The trial protocol should address insurance if not already addressed in a separate agreement.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12AD) and Schedule 5A
 
(2) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments  (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 5 and 8
 
(3) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 3 (3.3)
 
Sponsorship > Compensation
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SUMMARY
Overview
The AustraliaTGR directs the sponsor to comply with the requirements in the G-AustraliaGCP and the G-AusNatlStmt, which, in turn, mandate compensation for trial participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.
 
As per the G-AustraliaGCP and the G-AusNatlStmt, the informed consent form (ICF) should contain a statement with a description of the anticipated prorated payment to the participant(s) for participating in the trial. Per the G-AusNatlStmt, any compensation or payment to participants must not be disproportionate to the time involved, or include other incentives that encourage them to take risks. Further, compensation decisions should consider customs and practices of the community in which the trial will be conducted. (See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights).
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Section: Schedule 5A Item 3 (g)
 
(2) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments  (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 4, 5, and 8
 
(3) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 3 (3.3)
 
Sponsorship > Quality, Data & Records Management
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SUMMARY
Overview
As stated in the AustraliaTGR and the G-AustraliaGCP, 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 G-AustraliaGCP, and the applicable regulatory requirements. The sponsor is responsible for obtaining agreement from all involved parties to ensure direct access to all trial-related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. A written agreement must be signed by both the sponsor and investigator or any other parties involved with the clinical trial, verifying that parties agree to the trial protocol.
 
Electronic Data Processing System
When using electronic trial data handling processing systems, the sponsor must ensure and document that the electronic data processing system conforms to his/her established requirements for completeness, accuracy, reliability, and consistency of intended performance, and that he/she maintains SOPs for using these systems. Refer to the G-AustraliaGCP for additional information.
 
Record Management
As set forth in the G-AustraliaGCP, the sponsor is required to retain clinical trial data for 15 years following the completion of a clinical trial. However, the Therapeutic Goods Administration (TGA) advises that 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.
 
Audit Requirements
As part of its QA system, the G-AustraliaGCP 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 G-AustraliaGCP, 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 auditor’s qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with his/her own SOPs and the auditor observations are documented.
 
Premature Study Termination/Suspension
The G-AustraliaGCP states that if a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigator(s), institution(s), the ethics committee (known as Human Research Ethics Committee in Australia), and the TGA. The sponsor should provide the EC and the TGA with the reason(s) for the termination or suspension.
 
Multicenter Studies
As delineated in the G-AustraliaGCP, in the event of a multicenter trial, the sponsor must ensure that:
  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by the TGA
  • The EC approved the protocol
  • 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
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Part 3 (12AB)
 
(2) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments  (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 5
 
Sponsorship > Site/Investigator Selection
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SUMMARY
Overview
As set forth in the G-AustraliaGCP, 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. Furthermore, the sponsor must sign an agreement or contract with the participating investigator(s) and institution(s). (See the Clinical Trial Lifecycle topic, Submission Content subtopic for additional information on clinical trial application requirements).
 
Multicenter Trial
As per Additional Resource (A), if a multicenter trial is being conducted and if the project has been reviewed by an ethics committee (EC) affiliated with a certified institution, other participating institutions may choose to accept the review of this EC. Per Additional Resource (B), each institution wishing to participate in a multi-center trial, must conduct its own site-specific research governance assessment. Investigators at each site engage with their institutional research governance processes to obtain the authorization to commence research at each site. Many multicenter clinical trials are also subject to the requirements of the National Mutual Acceptance scheme operated by a cohort of Australian states and territories for research conducted in the publicly funded health sector. For more information on this approach, see Additional Resource (A).
 
Data Safety and Monitoring Board
Although not specified as a sponsor requirement, the G-AustraliaGCP states that a Data Safety and Monitoring Board (DSMB) (known as an Independent Data-Monitoring Committee in Australia) may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. The DSMB should have written standard operating procedures (SOPs) and maintain written records of all its meetings.
 
ADDITIONAL RESOURCES
(A) (Website) National Approach to Single Ethical Review of Multi-Centre Research (Last Updated November 18, 2016)
National Health and Medical Research Council, Australian Government
 
Relevant Section: National Certification Scheme
 
(B) (Website) What is Meant by ‘Single Ethics Review’? (Last updated November 18, 2016)
National Health and Medical Research Council, Australian Government
 
REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments  (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 4 and 5
 
Informed Consent > Documentation Requirements
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SUMMARY
Overview
In all Australian clinical trials, a freely given informed consent is required from each participant in accordance with the requirements set forth in the G-AustraliaGCP and the G-AusNatlStmt.
 
As per the G-AustraliaGCP, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (known as a Human Research Ethics Committee in Australia) and kept on file before the trial commences. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)
 
The G-AustraliaGCP states that the investigator must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The ICF content should be as non-technical as practical and understandable to the participants and/or his/her legal representative(s) or guardian(s). As per the G-AustraliaGCP and the G-AusNatlStmt, 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. Information presented to potential participants should help them make good choices. To this end, the investigator should take into account cultural and language barriers, the need for accurate and reliable translation, and whether there is a visual, hearing, or communication impairment. The participant and his/her legal representative(s) or guardian(s) should also be given adequate time to consider whether to participate.
 
Re-Consent
According to the G-AustraliaGCP and the G-AusNatlStmt, 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 and/or his/her legal representative(s) or guardian(s) 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.
 
Language Requirements
Pursuant to the G-AusNatlStmt, the ICF should be written in English and in a vernacular language that the participant is able to understand.
 
Documentation Copies
The G-AustraliaGCP states that the participant and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must sign and date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) 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 his/her legal representative(s) and/or guardian(s)
  • The participant and his/her legal representative(s) and/or guardian(s), have 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 his/her legal representative(s) and/or guardian(s) should receive a copy of the signed and dated ICF.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 1, 2, 4, and 8
 
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Section 2 (2.2) and Section 5 (5.2)
 
Informed Consent > Required Elements
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SUMMARY
Overview
As delineated in the G-AustraliaGCP and the G-AusNatlStmt, prior to beginning a clinical trial, the investigator is required to obtain ethics committee (EC) (known as Human Research Ethics Committee in Australia) approval for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s). For details on the requirements for obtaining consent, see the Informed Consent topic, Documentation Requirements subtopic.
 
No Coercion
As per the G-AustraliaGCP, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representative(s) from their liabilities for any negligence.
 
ICF Required Elements
Based on the G-AustraliaGCP and the G-AusNatlStmt, the ICF should include the following statements or descriptions, as applicable:
  • The study involves research and an explanation of its purpose and duration
  • The trial treatment(s) and the probability for random assignment to each treatment
  • The procedures to be followed, including all invasive procedures
  • The participant’s responsibilities
  • Those aspects of the trial that are experimental
  • Any reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
  • Any reasonably expected benefits; if no benefit is expected, the participant should be made aware of this
  • The disclosure of specific alternative procedure(s) or therapies available to the participant, and their important potential benefits and risks
  • Compensation and/or treatment available to the participant in the event of a trial-related injury
  • The anticipated prorated payment, if any, to the participant for participating in the trial
  • Any expenses the participant needs to pay to participate in the trial
  • That participation is voluntary, and that the participant can refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled
  • Confidentiality of records identifying the participant will be maintained, and permission given to monitors, the auditors, the ethics committee, and the Therapeutic Goods Administration (TGA) to access the participant’s medical records to verify the procedures and/or data, without violating the confidentiality of the participant, insofar as the applicable laws and regulations permit, and that, by signing a written ICF, the participant or the participant’s legal representative(s) or guardian(s) is authorizing such access
  • That records identifying the participant will not be made publicly available, insofar as the applicable laws and/or regulations permit; if the results of the trial are published, the participant’s identity will remain confidential
  • The participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if information becomes available that may affect the participant’s willingness to continue
  • The investigator’s contact information for further information regarding the trial and the rights of participants, and whom to contact in the event of a trial-related injury or complaint
  • Foreseeable circumstances and/or reasons under which the participant’s involvement in the trial may be terminated
  • The approximate number of participants in the trial
  • How the trial will be monitored
  • The amount and sources of funding for the research
  • Financial or other declarations of interests of researchers, sponsors, or institutions
  • Other relevant information, including research-specific information required under the G-AusNatlStmt
See the Informed Consent topic, Compensation Disclosure and Vulnerable Populations subtopics and the Specimens topic, Consent for Specimens subtopic for further information.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 4
 
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Section 2 (2.2) and Section 5 (5.1 and 5.2)
 
Informed Consent > Compensation Disclosure
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SUMMARY
Overview
In accordance with the G-AustraliaGCP and the G-AusNatlStmt, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial.
 
Compensation for Participation in Research
As per the G-AustraliaGCP and the G-AusNatlStmt, the ICF should contain a statement with a description of the anticipated prorated payment to the participant(s) for participating in the trial. Per the G-AusNatlStmt, any compensation or payment to participants must not be disproportionate to the time involved, or include other incentives that encourage them to take risks. Further, compensation decisions should consider customs and practices of the community in which the trial will be conducted.
 
Compensation for Injury
As per the G-AustraliaGCP, the ICF should include a statement advising the participant about whether compensation and medical treatment is available in the event of any trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: 1 and 5
 
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Section 2 (2.2) and Section 5 (5.2)
 
Informed Consent > Participant Rights
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SUMMARY
Overview
In accordance with the G-AustraliaGCP and the G-AusNatlStmt, Australia’s ethical standards protect participants’ rights and promote respect for human beings, research merit and integrity, justice, and beneficence. The G-AusNatlStmt 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).
 
The Right to Participate, Abstain, or Withdraw
As stated in the G-AustraliaGCP and the G-AusNatlStmt, the participant and/or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. Per the G-AusNatlStmt, 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 G-AustraliaGCP and the G-AusNatlStmt, a potential research participant and/or his legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation or treatment in the case of injury, and any significant new information regarding the research study.
 
The Right to Privacy and Confidentiality
According to the G-AustraliaGCP and the G-AusNatlStmt, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.
 
The Right of Inquiry/Appeal
The G-AustraliaGCP and the G-AusNatlStmt, state that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the individual responsible for addressing trial-related inquiries and/or his/her rights.
 
The Right to Safety and Welfare
The G-AustraliaGCP (which upholds the Declaration of Helsinki) and the G-AusNatlStmt, clearly state that a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.
 
See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Introduction, 2 , 4, and 8
 
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Purpose, Scope, and Limits of this Document, Section 1, Section 2 (2.2) and Section 5 (5.2)
 
Informed Consent > Special Circumstances/Emergencies
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SUMMARY
Overview
The G-AustraliaGCP and the G-AusNatlStmt make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances. Special circumstances can be medical emergencies or when a participant is mentally incapacitated, e.g., unconscious.
 
Medical Emergencies
As per the G-AustraliaGCP, if the signed informed consent form (ICF) has not been obtained from the research participant and/or his/her legal representative(s) or guardian(s), or, if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee (EC) (known as the Human Research Ethics Committee in Australia) must approve the protocol in advance. The participant and/or his/her legal representative(s) or guardian(s) should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.
 
Research Involving Unconscious Persons
The G-AusNatlStmt states when prior consent is not possible for research involving unconscious persons, consent should be provided by the participant’s legal representative(s) or guardian(s). Because of their extreme vulnerability, unconscious persons should be excluded from all but minimally invasive observational research, or in research designed both to be therapeutic for them and to improve treatment for the condition from which they suffer. See section 4.4 of the G-AusNatlStmt for more information regarding research involving unconscious persons.
 
Alteration of Consent
The G-AusNatlStmt specifies that although voluntary informed consent is always a requirement for every trial, the EC may approve an alteration of consent if the study satisfies all of the following conditions:
 
  • It involves only minimal 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
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 4
 
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Section 2 (2.3) and Section 4 (4.4)
 
Informed Consent > Vulnerable Populations
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SUMMARY

Overview
All Australian clinical trials that involve research participants selected from vulnerable populations must follow special processes for consent, as delineated in the G-AusNatlStmt. The G-AusNatlStmt 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; governmental authorities and refugees, employers/supervisors and their employees (including members of police and Defense Forces), service-providers and vulnerable communities. Where potential participants are especially vulnerable or powerless, consideration should be given to the appointment of a participant advocate.

The G-AustraliaGCP characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response 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 people who may be involved in illegal activities, ethnic minority groups such as the Aboriginal and Torres Strait Islander peoples, people in other countries, patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Participants in Terminal Care
The G-AusNatlStmt 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.

Participants Who May Be Involved in Illegal Activities
The G-AusNatlStmt 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 ethics committee (EC) (known as Human Research Ethics Committee in Australia). The investigator(s) should be satisfied that potential participants are aware that the research may discover illegal activity and do not have unrealistic expectations of benefit from their participation. Finally, this research 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-AusNatlStmt.

Aboriginal and Torres Strait Islander Peoples
The G-AusNatlStmt 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 Aboriginal and Torres Strait Islander people. In addition, the investigator 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 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 G-AustraliaAboriginalValuesEthics and G-AustraliaAboriginalEthicsOnTrack.

People in Other Countries
The G-AusNatlStmt states that research involving people in other countries must be reviewed and approved by an EC and comply with the G-AusNatlStmt. 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-AusNatlStmt. Additional details are provided in the G-AusNatlStmt.

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

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015) National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 4 (Introduction, 4.6, 4.7, and 4.8)
 
(2) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 1
 
(3) (Guidance) Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (G-AustraliaAboriginalValuesEthics) (June 5, 2003)
National Health and Medical Research Council, Australian Government
 
(4) (Guidance) Keeping Research on Track - A guide for Aboriginal and Torres Strait Islander peoples about health research ethics (G-AustraliaAboriginalEthicsOnTrack) (December 8, 2005)
National Health and Medical Research Council and Australian Health Ethics Committee, Australian Government
 
Informed Consent > Children/Minors
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SUMMARY
Overview
Under Australian law, the age of majority is 18. However, in accordance with the G-AusNatlStmt, when the research participant is a child or young person it is not possible to attach fixed ages to their capacity to consent. The informed consent form (ICF) must be signed by the child or young person whenever he/she has the capacity to make this decision, and either one parent, except when the ethics committee (EC) (known as Human Research Ethics Committee in Australia) decides that the risks require the consent of both parents, or the child or young person’s legal representative(s) or guardian(s). The G-AustraliaGCP states that children and young people should be informed to the extent compatible with their understanding, and if capable, they should sign and personally date the ICF.
 
In accordance with the G-AusNatlStmt, informed consent requirements for conducting clinical trials follow the general requirements listed in the Informed Consent topic, Required Elements subtopic. In addition, as stated in the G-AusNatlStmt, children and young people 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 his/her welfare.
 
Consent
As per the G-AusNatlStmt, if the child or young person has the capacity for consent, his/her affirmative consent is required to participate in a study according to his/her level of development and capacities. The following guidelines on maturity and corresponding capacity to consent are provided:
  • Infants 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
The EC may approve research to which only the child or young person consents if it is satisfied that:
  • He/she 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 his/her legal representative(s) or guardian(s) and the researcher ensures his/her 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 his/her legal representative(s) or guardian(s), and the researcher ensures his/her safety, security, and well-being in the research conduct
Regarding dissent, the G-AusNatlStmt states that the researchers must respect the dissent of a child or young person who was required to give consent.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 4 (4.2)
 
(2) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 4.2
 
Informed Consent > Pregnant Women, Fetuses & Neonates
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SUMMARY
Overview
As per the G-AusNatlStmt, 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.
 
In accordance with the G-AusNatlStmt, informed consent requirements for conducting clinical trials follow the general requirements listed in the Informed Consent topic, Required Elements subtopic. In addition, research proposals must include procedures to ensure that the process of providing information and obtaining consent is clearly separate from clinical care. A researcher who is also the treating health professional should not be the person who seeks the consent of the potential participant unless there is a specific justification for doing so. The wellbeing and care of the woman who is pregnant and of her fetus always takes precedence over research considerations. 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. For requirements related to research on embryos and deceased fetuses, see Additional Resource (A).
 
Further, the woman should be informed of the following:
  • 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

 

ADDITIONAL RESOURCES
National Health and Medical Research Council, Australian Government
 
REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 4 (4.1)
 
Informed Consent > Prisoners
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SUMMARY
Overview
According to the G-AusNatlStmt, prisoners are considered vulnerable because incarceration could affect their ability to make voluntary decisions regarding participation in research. A research study involving 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.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 4 (4.3)
 
Informed Consent > Mentally Impaired
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SUMMARY
Overview
According to the G-AusNatlStmt, the ethics committee (known as Human Research Ethics Committee in Australia) must approve the participation of research participants who are mentally incapable of giving consent. While the G-AusNatlStmt distinguishes mental impairment from intellectual disability and mental illness, the informed consent guidelines are similar. As delineated in the G-AusNatlStmt, the mentally impaired participant must consent if she/she has the capacity, or the participant’s legal representative(s) or guardian(s) must consent on behalf of the mentally impaired participant. Where a legal representative(s) or guardian(s) 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 him/her the opportunity to continue participation or withdraw. Dissent will preclude participation of a mentally impaired person.
 
If the participant’s mental impairment is temporary or episodic, researchers should seek consent when the condition does not interfere with his/her capacity to give consent. This consent should occur in the presence of a witness that is familiar with the participant, is independent from the research, and understands the research’s merits, risks, and procedures.
 
ADDITIONAL RESOURCES

No additional resources 

REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 4 (4.5)
 
Investigational Products > Definition of Investigational Product
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SUMMARY
Overview
According to the G-AustraliaGCP, 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.
 
In Australia, IPs are also referred to as unapproved therapeutic goods. As per Additional Resources (A) and (B), an unapproved therapeutic good includes:
  • Any medicine, biological, or medical device not entered on the Australian Register of Therapeutic Goods (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
  • Any therapeutic good already in the ARTG that is used beyond the conditions of its marketing approval including labelling
According to the G-AustraliaCTHandbook, the G-AustraliaUnapprovedTGs, and Additional Resource (A), ARTG-listed medicines that are used in clinical trials within the conditions of their marketing approval are not considered IPs.
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trials at a Glance (Last Updated April 29, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Australian Clinical Trials – The Regulatory Environment (Current as of March 20, 2017)
National Health and Medical Research Council, Department of Industry, Innovation, and Science, Australian Government
 
(C) (Website) Australian Register of Therapeutic Goods (Last Updated April 21, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 1
 
(2) (Guidance) The Australian Clinical Trial Handbook (G-AustraliaCTHandbook) (March 2006)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Introduction, and Clinical Trial Medicines - Manufacture, Import, Export, and Documentation
 
(3) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Introduction - The Legal Basis for Supply of Unapproved Therapeutic Goods, and Regulation of Medicine and Medical Device Clinical Trials in Australia – An Introduction to the CTN and CTX Schemes
 
Investigational Products > Manufacturing & Import
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SUMMARY
Overview
As specified in the AustraliaTGAct, the AustraliaTGR, and the G-AustraliaUnapprovedTGs, the Therapeutic Goods Administration (TGA) authorizes the manufacture of investigational products (IPs) in Australia. As per Additional Resources (A), (B), (C), and (D), the sponsor provides manufacturer information to TGA in the clinical trial application (CTA) under one of the two (2) regulatory schemes—the Clinical Trial Notification (CTN) Scheme or the Clinical Trial Exemption (CTX) Scheme. Pursuant to AustraliaTGManufacturing, Australia adopted Additional Resource (E) to guide the manufacture of therapeutic goods. (See Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed application requirements).
 
As per the AustraliaTGAct, the AustraliaTGR, and Additional Resource (F), the Experimental Products Section of the TGA authorizes the import and export of IPs. Additional Resource (G) provides the application form to obtain TGA approval to import or export IPs, which requires the following:
  • Applicant details and declaration
  • Type of application—import, export, and whether it is a new application, a renewal, or adding a country to an existing approval
  • Trial details, including protocol number
  • Details of goods to be exported and export destinations
  • Manufacturer details, including certification that the goods were manufactured pursuant to Good Manufacturing Practices (GMP)
  • A copy of the TGA GMP certificate number if the IP was manufactured in Australia
  • A sponsor assurance that the trial will be conducted in accordance with G-AustraliaGCP
  • Six (6)-month reports, if applicable
  • Customs permits, if applicable
Further, per the AustraliaTGR, the sponsor must provide a written assurance to comply with any trial-related requests by an authorized TGA officer(s), which includes allowing him/her to inspect clinical trial sites. The principal investigator is required to comply with requests and answer any questions the authorized officer(s) may have.
 
ADDITIONAL RESOURCES
(A) (Website) CTN Scheme Forms (Last Updated September 8, 2015)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Completing the Online CTN Form (Last Updated August 23, 2016)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: Medicine Details, Manufacturer Details
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
 
Relevant Section: Annex 13
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
Therapeutic Goods Administration, Department of Health, Australian Government
 
REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part 3-2 (19)) and (Part 3-3 (34-38))
 
(2) (Regulation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 75) (AustraliaTGR) (Amended January 1, 2017)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Section: 12AB and 12AC
 
(3) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs) (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Sections: Introduction, and The Legislative Basis for Clinical Trials: Acts and Regulations governing the manufacture of medicines used in clinical trials
 
(4) (Legislation) Therapeutic Goods Act of 1989, Therapeutic Goods (Manufacturing Principles) (Determination No. 1 of 2013, MP1/2013) (AustraliaTGManufacturing) (May 20, 2013)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Interpretation and Division 1
 
(5) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 1
 
Investigational Products > IMP/IND Quality Requirements
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SUMMARY
Overview
According to the G-AustraliaGCP, 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). The sponsor must ensure that an up-to-date IP is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee.
 
IB Content Requirements
The G-AustraliaGCP 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 (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
  • Summary of data and guidance for the investigator(s)
See Section 7 of the G-AustraliaGCP for detailed content guidelines.
 
The sponsor is also accountable for supplying the IP, which includes ensuring that the IP is supplied by another designated or contracted party, including the comparator(s) and placebo, if applicable. As specified in the G-AustraliaGCP, the sponsor must ensure that the products are manufactured in accordance with Good Manufacturing Practices (GMPs).
 
Certificate of Analysis
Pursuant to the G-AustraliaGCP, 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.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 7
 
Investigational Products > Labeling & Packaging
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SUMMARY
Overview
Investigational product (IP) labeling in Australia must comply with the requirements set forth in the G-AustraliaUnapprovedTGs, the G-AustraliaGCP, and Additional Resource (B). The following information must be included on the IP label:
  • Sponsor’s name
  • Pharmaceutical dosage form, route of administration, and quantity of dosage units
  • The batch and/or code number to identify the contents and packaging operation
  • The trial participant identification number, if applicable
  • Investigator’s name
  • Directions for use
  • “For clinical trial use only”
  • Investigator’s name
  • The protocol number or code
  • The storage conditions
  • The period of use
  • “Keep out of reach of children” except when the product is for use only in hospital
  • Warnings and/or handling instructions
Additional details are provided in the G-AustraliaUnapprovedTGs.
 
ADDITIONAL RESOURCES
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: What are labelling requirements for investigational medicinal products (IMP) in clinical trials?
 
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme
 
Relevant Section: Annex 13
 
REQUIREMENTS
(1) (Guidance) Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (G-AustraliaUnapprovedTGs (October 2004)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: The Legislative Basis for Clinical Trials: Acts and Regulations governing the manufacture of medicines used in clinical trials
 
(2) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 5.13
 
Investigational Products > Product Management
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SUMMARY
Overview
In accordance with the G-AustraliaGCP, 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 clinical and nonclinical studies, safety, marketing information, and physical, chemical, pharmaceutical, pharmacological, pharmacokinetic, metabolic, and toxicological information. The sponsor must ensure that an up-to-date IP is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee.
 
Investigational Product Supply, Storage, and Handling Requirements
As defined in the G-AustraliaGCP and Additional Resource (A), the sponsor must supply the investigator(s) with the IP(s), including the comparator and placebo, if applicable. The sponsor should not supply the IP(s) until he/she obtains approvals from the Therapeutic Goods Administration (TGA) and the institutional ethics committee (EC).
 
The G-AustraliaGCP 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
Refer to the G-AustraliaGCP, for detailed sponsor-related IP requirements.
 
Record Requirements
As set forth in the G-AustraliaGCP, 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 of the need for record retention and should notify the investigator(s) and institution(s) in writing when the trial-related records are no longer needed.
 
ADDITIONAL RESOURCES
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme
 
Relevant Section: Annex 13
 
REQUIREMENTS
(1) (Guidance) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA Comments (G-AustraliaGCP) (July 2000)
Therapeutic Goods Administration, Department of Health, Australian Government
 
Relevant Section: 5
 
Specimens > Definition of Specimen
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SUMMARY
Overview
In Australia, a specimen is referred to as a “human biospecimen.” In addition, according to the AustraliaTGAct, a human biospecimen is made from, or contains, human cells or human tissues that are used to:
  • Treat or prevent disease, ailment, defect, or injury
  • Diagnose a 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 body parts
The G-AusNatlStmt 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 does not use standard terminology, but generally refers to human biospecimens as ‘human tissue.’
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 66) (AustraliaTGAct) (Amended November 23, 2016)
Office of Parliamentary Counsel, Canberra, Australian Government
 
Relevant Sections: Chapter 3 (Part 3‑2A)
 
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 3 (3.4)
 
Specimens > Import & Export
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SUMMARY
Overview
Per the G-AusNatlStmt, if a human biospecimen will be, or has been, imported for research, investigators must establish whether the human biospecimen was obtained in a manner consistent with the requirements of the G-AusNatlStmt and relevant Australian legislation. If this cannot be established, then the human biospecimen should not be used for research in Australia. Further, a human biospecimen obtained in Australia may be sent overseas for research if its exportation is consistent with the original consent and the approval by an ethics committee (EC) (known as a Human Research Ethics Committee in Australia) is obtained. Per Additional Resource (A), an application to request permission to export human body fluids, organs and other tissue, or a substance derived from human blood must be submitted to the Therapeutic Goods Administration (TGA). The application form requires the reason for the request, which can include research purposes.
 
Per Additional Resources (B), (C), and (D), restrictions may be imposed on the importation and exportation of therapeutic goods through other legislation:
  • Customs (Prohibited Imports) Regulations 1956 and Customs (Prohibited Exports) Regulations 1958 – provides substances that are prohibited under the Customs legislation
  • The Biosecurity Act 2015 – permission may be required from the Department of Agriculture and Water Resources prior to importing any material of biological origin (human, animal, plant, or microbial)
  • Environment Protection and Biodiversity Conservation Act of 1999 – permission may be required from the Department of the Environment and Energy prior to importing or exporting plants and animals

 

ADDITIONAL RESOURCES
(A) (Form) Facsimile - Request for Approval to Export (Date Unavailable)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(B) (Website) Import and Export (Current as of April 4, 2017)
Therapeutic Goods Administration, Department of Health, Australian Government
 
(C) (Website) Importing Therapeutic Substances, Foods and Dietary Supplements (Last Reviewed June 9, 2016)
Department of Agriculture and Water Resources, Australian Government
 
(D) (Website) How to bring CITES plants and animals into and out of Australia (Current as of April 4, 2017)
Department of the Environment and Energy, Australian Government
 
REQUIREMENTS
(1) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Section: Section 3 (3.4)
 
Specimens > Consent for Specimens
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Last content review/update: April 05, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with the G-AusNatlStmt, prior to collecting human biospecimens, consent must be obtained from the participant and/or his/her legal representative(s). The general requirements for consent must be met, including the investigator(s) obtaining ethics committee (EC) (known as Human Research Ethics Committee (HREC) in Australia) review and approval of the proposed consent, collection, processing, storage and distribution, and disposal. This requirement pertains to human biospecimens that are collected for a specific clinical research project or placed into a biobank for future research use.
 
In addition, the investigator must provide potential participants with information about:
  • The research for which their biospecimens will be used and, where extended or unspecified consent is sought, and sufficient information is provided to meet the general requirements of consent
  • How their biospecimens will be stored, used, and disposed of, including any processes to be adopted that respect their personal or cultural sensitivities
  • The extent to which their biospecimens will be reasonably identifiable, and how their privacy and confidentiality will be protected
  • Whether the biospecimen research is likely to provide information that may be important to their health or to the health of their blood relatives or their community, and, if they have the choice to share this information, how this will be managed
  • Whether their biospecimens and associated data may be distributed to other researchers, including those outside Australia
  • Their right to withdraw consent for the continued use of their biospecimens or associated data in research, and any limitations that may be relevant to their withdrawal of consent
  • Any relevant financial or personal interests that those engaged in the collection, processing, storage and distribution, and use of their biospecimens may have
  • Any potential for commercial application of any outcomes of the research and how this will be managed and to whom the benefits, if any, will be distributed
Human biospecimens that were previously obtained for clinical purposes and have been retained by an accredited clinical pathology service, may be used if the identity of the donor is not needed. If the donor’s identity is needed, a request for the waiver of the requirement for consent to use existing collections of human biospecimens can be submitted to an EC.
 
With regard to biospecimens post-mortem, any wish expressed by a person about the use of their biospecimens post-mortem should be respected. If no such wish is discovered, researchers seeking to obtain human biospecimens post-mortem should obtain consent from the person(s) authorized by relevant legislation.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(2) (Guidance) National Statement on Ethical Conduct in Human Research 2007 (G-AusNatlStmt) (Updated May 2015)
National Health and Medical Research Council and Australian Research Council, Australian Government
 
Relevant Sections: Section 2 (2.2 and 2.3), and Section 3 (3.4)
 
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OMB #: 0925-0668
Expiration Date: 2/28/2019