Good Clinical Practice (ICH-GCP; ISO 14155) Guidelines

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Overview

Good Clinical Practice (GCP) is the international, ethical, scientific, and quality standard for the conduct of clinical trials, and represents the underlying principles described in the Nuremberg Code, Declaration of Helsinki, Belmont Report, DHHS and FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (ICH-GCP), and International Standards Organization (ISO) 14155 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice.

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 (drug and biologics trials) and ISO 14155 (device trials) documents. These guidance documents set forth international GCP standards for investigational products; ICH GCP has been adopted as guidance by the FDA and ISO 14155 has been recognized as a consensus standard. 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. Similarly, ISO published a fourth edition of ISO 14155 in March 2026, replacing the third edition from 2020.

When is Compliance with GCP required at UCSF?

GCP guidelines must be followed when generating clinical trial data intended for submission to international regulatory authorities. Additionally, if the study sponsor, protocol, clinical trial agreement, or any other study-specific documentation requires compliance with GCP guidelines (ICH-GCP or ISO 14155), then the study team is responsible for ensuring compliance with these guidelines. If unclear whether a study is subject to GCP requirements, confirm with the sponsor.

Additionally, the NIH encourages researchers to follow GCP as best practice for NIH-funded clinical trials, but does not currently require that clinical trials comply with GCP. The NIH requires training in GCP to help ensure the safety, integrity, and quality of clinical trials.

GCP Training at UCSF

UCSF integrates the recent GCP updates into our existing training through UCSF’s CITI program:

  • UCSF Training Requirement: Researchers and study staff conducting research subject to GCP requirements must enroll and complete in one of the following CITI courses or refreshers available through UCSF’s catalogue:
    • CITI Good Clinical Practice Course (updated May 2026, 3-hour completion): for drug, biologic, and device trials.
    • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus; updated July 2025, 3-hour completion): for drug and biologic trials.
    • GCP for Clinical Investigations of Devices (updated May 2026): for device trials.
    • ICH E6(R3): An Introduction (1-hour completion): for UCSF personnel who have previously completed a CITI ICH-GCP course and require an update on the E6 (R3) changes.
  • Sponsor Requirements: Please note that individual research sponsors may require current GCP training, given the updates to ICH-GCP and ISO. 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 GCP requirements must ensure completion of one of the above courses prior to conducting research activities.
  • Renewal Cycle: Researchers and study staff conducting research subject to GCP requirements must continue to complete GCP training every 3 years through CITI.

Supplemental Resources to CITI Training

Topic-focused Resources

General Overview Resources

Additional Local Resources