Resources
Clinical trials
If your research involves clinical trials, please contact the Ethics
Office before proceeding with a HRE application.
Clinical trial applications are completed and submitted via the national Human Research Ethics Application (HREA).
Additional resources
- Australian Clinical Trials
- Therapeutic Goods Act 1989
- Therapeutic Goods Regulations 1990
- AHEC consensus statement on clinical ethics
- Clinical Trials Notification (CTN) scheme
- Clinical Trials Approval (CTA) scheme (Previously, 'Clinical Trials Exemption (CTX) scheme')
- Competencies for Australian Academic Clinical Trialists
- Good Practice Process for Site Assessment and Authorisation of Clinical Trials
- Guidance for Good Clinical Practice (ICH-GCP) (annotated by the TGA)
- Indemnity and Insurance Arrangements for Clinical Trials in the Public and Private Sectors in Australia
- NHMRC eLearning Modules – Clinical trials
- NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods
- TGA’s Clinical Trial website
- The Australian Clinical Trial Handbook
- Clinical Ethics Capacity Building Resource Manual
- Data Safety Monitoring Boards (DSMBs)
The UniSQ Insurance team will also need to be consulted before submitting an HREA application.