Workshop on Sponsor Oversight of IITs
Learn what is required for sponsor oversight of Investigator-Initiated Trials (IITs).
Last updated 24 May 2026
The workshop on Sponsor Oversight of Investigator-Initiated Trials (IITs) was held at HSA Auditorium on 14 Nov 2025, covering the following topics:
Principles of ICH E6 (R3) GCP Guideline [PDF, 870 KB] (opens in new tab)
Sponsor Documented Procedures for IITs [PDF, 604 KB] (opens in new tab)
Proportionate Risk-based Quality Management for IITs [PDF, 1.3 MB] (opens in new tab)
Version date: 14 Nov 2025