Overview
The International Council for Harmonisation (ICH) released the revised Good Clinical Practice guideline ICH E6 (R3) in January 2025, with FDA adoption following on September 9, 2025. ICH-GCP E6 (R3) applies to interventional clinical trials of investigational products intended to be submitted to international regulatory authorities. These revisions reflect current approaches to clinical research, including decentralized models, data governance, quality-by-design, and risk-based oversight.
What is Good Clinical Practice (GCP)?
The term GCP is often used broadly to describe best practices when conducting clinical research. These practices set the standards for designing, conducting, monitoring, auditing, recording, analyzing, and reporting of clinical research that involves human subjects. Compliance with this standard provides public assurance that the rights, safety, and welfare of human subjects in research are protected and that the data collected are reliable and credible.
The term GCP is also used more narrowly to describe the International Council for Harmonisation (ICH) GCP E6 document itself. GCP describes the unified standard to facilitate the mutual acceptance of data from clinical trials by international regulatory authorities.
When is Compliance with ICH-GCP required at UCSF?
ICH-GCP guidelines must be followed when generating clinical trial data intended for submission to international regulatory authorities. If the study sponsor, protocol, clinical trial agreement, or any other study-specific documentation requires compliance with the ICH-GCP guidelines, then the Principal Investigator (PI) is responsible for ensuring compliance with these guidelines. If unclear whether a study is subject to ICH-GCP requirements, confirm with the sponsor.
Additionally, the NIH encourages researchers to follow ICH-GCP as best practice for NIH-funded clinical trials, but does not currently require that clinical trials comply with ICH-GCP. The NIH requires training in ICH-GCP to help ensure the safety, integrity, and quality of clinical trials.
ICH-GCP E6 (R3) Training at UCSF
UCSF will integrate the ICH-GCP E6 (R3) updates into our existing process through UCSF’s CITI program:
- UCSF Training Requirement: Researchers and study staff conducting research subject to ICH-GCP requirements must enroll in one of the following CITI courses available through UCSF’s catalogue:
- ICH E6(R3): An Introduction (1-hour completion): for UCSF personnel who have previously completed a CITI GCP course; or
- For UCSF personnel who have not completed any GCP training prior to receiving this notice, please complete one of the following updated courses:
- CITI Good Clinical Practice Course (updated Oct. 2025, 3-hour completion)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus; updated July 2025, 3-hour completion).
- Note: Researchers and study staff who have already completed one of the updated GCP courses do not need to enroll in the “ICH E6(R3): An Introduction” course for training on the new E6(R3) requirements.
- Sponsor Requirements: Please note that individual research sponsors may require updated GCP training. Faculty and staff are encouraged to check with sponsors to confirm specific expectations. ICH-GCP training requirements may be fulfilled through the courses listed above.
- Timing: Researchers and study staff conducting research subject to ICH-GCP requirements must ensure completion of one of the above courses by January 31, 2026.
- Renewal Cycle: Researchers and study staff conducting research subject to ICH-GCP requirements must continue to complete GCP training every 3 years through CITI.
Supplemental Resources to CITI Training
Topic-focused Resources
- Coming soon!
General Overview Resources