Regulatory Guidelines and Forms

---

Regulatory approval and good clinical practice requirements Regulatory approval and good clinical practice requirements - January 2026 (PDF 530 KB, 33 pages)

Clinical Trial Safety Monitoring and Reporting - January 2026 (PDF 345 KB, 14 pages)

Considerations for first-in-human (FIH) and early phase clinical trials - January 2026 (PDF 256 KB, 6 pages)

---

Clinical Trial Site Notification Form - 2018 (PDF 76 KB, 2 pages)

Investigator CV template - February 2026  (Word, 60 KB, 2 pages)

Clinical Trials Process - Guidance for sponsors

---

Updated Guidance on Clinical Trials Process for sponsors - 28 August 2026

Policy Statement on Clinical trials – Protocol clarification letters - 12 March 2025

Introducing an abbreviated process for eligible clinical trials - 17 May 2011

Self-Certified Clinical Trial Site Notification scheme

---

Self-certified sites that have study participants in residence while the clinical trial medicines are administered

Clinical Trial Site Notification Form- 2018 (PDF 76 KB, 2 pages)