Australia Profile Updated

February 10, 2023
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The Australia profile in ClinRegs has been reviewed and updated with the following information:

  • Data protection requirements related to the collection and handling of personal information, including health information, under the Privacy Act 1988 and the Australian Privacy Principles (See Personal Data Protection)
  • Information regarding the National Health and Medical Research Council (NHMRC)’s guidelines under Sections 95 and 95A of the Privacy Act 1988, which cover the handling of health information for research purposes without individuals' consent (See Personal Data Protection)
  • More detailed payment instructions for clinical trial application fees to the Therapeutic Goods Administration (TGA) (See Regulatory Fees)
  • Additional details on ethics committee requirements regarding the National Mutual Acceptance Scheme (See Scope of Review and Oversight of Ethics Committees)
  • Additional information on children and informed consent from the Department of Health and Aged Care (See Children/Minors)

Sources Added During this Update:

(Guidance) AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (G-AIATSISCode) (2020)
Australian Institute of Aboriginal and Torres Strait Islander Studies

(Guidance) Guidelines Approved Under Section 95A of the Privacy Act 1988 (G-PrivacyAct95A) (March 2014)
National Health and Medical Research Council

(Guidance) Guidelines Under Section 95 of the Privacy Act 1988 (G-PrivacyAct95) (November 2014)
National Health and Medical Research Council

(Document) National Certification Scheme: Institutions with Certified Ethics Review Processes (AUS-68) (September 2021)
National Health and Medical Research Council

(Webpage) Clinical Trials and Children (AUS-71) (Last Updated February 19, 2015)
Department of Health and Aged Care

(Webpage) How to Check the Status of Your CTN (AUS-69) (Version 1.2) (Last Updated August 21, 2020)
Therapeutic Goods Administration, Department of Health and Aged Care

(Webpage) Manufacturing Therapeutic Goods (AUS-72) (Current as of February 10, 2023)
Therapeutic Goods Administration, Department of Health and Aged Care

Sources Revised During this Update:

(Guidance) Export of Human Substances (G-SpecExport) (Version 2) (January 2023)
Therapeutic Goods Administration, Department of Health and Aged Care

(Guidance) National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia (G-TrialsSOP) (Last Updated June 14, 2022)
Department of Health and Aged Care

(Webpage) Health and Medical Research (AUS-70) (Current as of February 10, 2023)
Office of the Australian Information Commissioner

(Webpage) Payment Options (AUS-66) (Last Updated November 24, 2022)
Therapeutic Goods Administration, Department of Health and Aged Care

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