National/International guidance
Ethics and research conduct
- Australian Code for the Responsible Conduct of Research and supporting guidance documents
- National Statement on Ethical Conduct in Human Research
- Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
- Ethical Consideration in Quality Assurance and Evaluation Activities
- WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
Privacy and guardianship
- Health Records Act (Vic)
- Privacy Act (Vic)
- Guardianship and Administration Act (PDF)
- Commonwealth Privacy Amendment (Enhancing Privacy Protection) Act 2012
Research design
- Observational research - STROBE Statement Strengthening the Reporting of Observational Studies in Epidemiology
- Health research - Enhancing the quality and transparency of health research
- Clinical trials - CONSORT Statement
- Clinical trials - Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2), dated 9 November 2016 Annotated with TGA comments
Clinical trials, safety reporting and oversight of research
- The Australian Clinical Trials Handbook (TGA)
- Access to unapproved therapeutic goods; Clinical trials in Australia (PDF)
- NHMRC Guidance - Safety monitoring and reporting in clinical trials involving therapeutic goods (EH59) 2016 and supporting guidance documents Reporting of Serious Breaches...(EH59a) 2018, Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods (EH59B) 2018 and Data Safety Monitoring Boards (DSMBs) (EH59c) 2018
- Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2), dated 9 November 2016 Annotated with TGA comments
- Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF)
- VMIA Clinical Trials Risk and Insurance Guide
- Therapeutic Goods Act (TGA)
- Therapeutic Goods (Medical Devices) Regulation (TGA)
Good Clinical Practice (GCP)
- Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2), dated 9 November 2016 Annotated with TGA comments
Human tissue and genes
Radiation in research
- Radiation Act (VIC) (PDF)
- Radiation Regulations (VIC) (PDF)
- Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Code of Practice for Exposure of Humans to Ionizing Radiation for Research Purposes (PDF)
- ARPANSA Code of Practice for Radiation Protection in the Medical Applications of Ionizing Radiation (PDF)