Revised: 9 February 2026
Medicines
Clinical Trials
Regulatory Guideline
Policy Statement on Clinical trials – Protocol clarification letters
Regulatory approval and good clinical practice requirements Regulatory approval and good clinical practice requirements
- Current UNTIL 1 July 2026 (PDF 273 KB, 26 pages
- Current FROM 1 July 2026 (PDF 530 KB, 33 pages) - you may use these guidelines from 15 January 2026.
Clinical Trial Safety Monitoring and Reporting (PDF 345 KB, 14 pages)
Considerations for first-in-human (FIH) and early phase clinical trials (PDF 256 KB, 6 pages)
Clinical Trial Site Notification Form (PDF 76 KB, 2 pages)
Investigator CV template (Word, 56 KB, 1 page)
Self-Certified Clinical Trial Site Notification scheme
Self-certified sites that have study participants in residence while the clinical trial medicines are administered.
