Australia Profile Updated
The Australia profile in ClinRegs has been reviewed and updated with the following information:
- Revised National Health and Medical Research Council (NHMRC) guidance on ethics committee requirements and research governance responsibilities of institutions (See the Ethics Committee topic, Submission Content, Progress Reporting, Risk & Quality Management, Documentation Requirements, and Required Elements)
- Updated Therapeutic Goods Administration (TGA) payment instructions (See Regulatory Fees)
- Revised user guide for submitting a clinical trial notification (CTN) form (See Submission Process, Submission Content, and Progress Reporting)
- TGA pre-submission resources for clinical trial approval (CTA) scheme applications (See Scope of Assessment and Submission Process)
- New form for reporting a significant safety issue or urgent safety measure (See Safety Reporting)
- Minor revisions throughout the profile to reflect the recent reorganization of the Australian Clinical Trials webpage
Sources Added During this Update:
(Legislation) Family Law Act 1975 (No. 53, 1975, Compilation No. 97) (FamLawAct) (Amended November 28, 2023)
Office of Parliamentary Counsel
(Form) Clinical Trial Significant Safety Issue/Urgent Safety Measure Safety Reporting Form (SSI/USM) (AUS-37) (June 2023)
Therapeutic Goods Administration, Department of Health and Aged Care
(Webpage) Good Clinical Practice Inspection Program: Frequently Asked Questions (AUS-59) (Last Updated August 5, 2022)
Therapeutic Goods Administration, Department of Health and Aged Care
(Webpage) Pre-Submission Meeting Forms (AUS-17) (Last Updated March 2, 2018)
Therapeutic Goods Administration, Department of Health and Aged Care
(Webpage) Roles and Responsibilities for Clinical Trial Safety Reporting of Significant Safety Issues and Urgent Safety Measures (AUS-53) (Current as of May 1, 2024)
Therapeutic Goods Administration, Department of Health and Aged Care
Sources Revised During this Update:
(Guidance) Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research 2017 (Updated 2023) (G-EthicsART) (April 17, 2023)
National Health and Medical Research Council
(Guidance) Export of Human Substances (G-SpecExport) (Version 3.2) (November 2023)
Therapeutic Goods Administration, Department of Health and Aged Care
(Guidance) Fees and Charges: Summary - from 1 July 2023 (G-FeesCharges) (Version 2) (November 2023)
Therapeutic Goods Administration, Department of Health and Aged Care
(Guidance) National Health and Medical Research Council 2014 (updated 2024): Guidelines Under Section 95 of the Privacy Act 1988 (G-PrivacyAct95) (March 2024)
National Health and Medical Research Council
(Guidance) National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia (G-TrialsSOP) (Last Updated July 7, 2023)
Department of Health and Aged Care
(Guidance) National Statement on Ethical Conduct in Human Research 2023 (G-NatlStmt) (Effective January 1, 2024)
National Health and Medical Research Council, and Australian Research Council, and Universities Australia
(Legislation) Privacy Act 1988 (No. 119, 1988, Compilation No. 97) (PrivacyAct) (Amended October 18, 2023)
Office of Parliamentary Counsel
(Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 84) (TGAct) (Amended September 21, 2023)
Office of Parliamentary Counsel
(Legislation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 117) (TGR) (Amended March 1, 2024)
Office of Parliamentary Counsel
(Document) Clinical Trial Notification (CTN) Form - User Guide (AUS-49) (Version 1.3) (March 2024)
Therapeutic Goods Administration, Department of Health and Aged Care
(Document) National Certification Scheme: Institutions with Certified Ethics Review Processes (AUS-68) (Date Unavailable)
National Health and Medical Research Council
(Webpage) Apply for Ethics Approval for a Clinical Trial (AUS-41) (Last Updated November 7, 2023)
Australian Clinical Trials, Department of Health and Aged Care
(Webpage) Concerns About a Clinical Trial (AUS-45) (Last Updated December 4, 2023)
Australian Clinical Trials, Department of Health and Aged Care
(Webpage) Good Clinical Practice (GCP) for Clinical Trials in Australia (AUS-14) (Last Updated October 25, 2023)
Australian Clinical Trials, Department of Health and Aged Care
(Webpage) How to Talk to Potential Clinical Trial Participants (AUS-65) (Last Updated October 24, 2023)
Australian Clinical Trials, Department of Health and Aged Care
(Webpage) Payment Options (AUS-66) (Last Updated June 2, 2023)
Therapeutic Goods Administration, Department of Health and Aged Care
(Webpage) Principles, Regulations and Governance of Clinical Trials (AUS-40) (Last Updated January 29, 2024)
Australian Clinical Trials, Department of Health and Aged Care
(Webpage) Register a Clinical Trial in Australia (AUS-15) (Last Updated November 7, 2023)
Australian Clinical Trials, Department of Health and Aged Care
(Webpage) Who Can Participate in a Clinical Trial (AUS-71) (Last Updated January 29, 2024)
Australian Clinical Trials, Department of Health and Aged Care