What Is ICH GCP, And How Does It Impact Clinical Planning?

The International Council for Harmonization (ICH) has released an updated Good Clinical Practice (GCP) guideline, effective July 23, 2025. ICH GCP provides an international standard for the ethical, scientific, and quality conduct of clinical trials involving human participants.

Trials conducted in accordance with this guideline help ensure that participants’ rights, safety, and well-being are protected, that study conduct aligns with the principles of the Declaration of Helsinki, and that trial results are reliable and credible. Originally established 30 years ago, the guideline prioritized patient safety and emphasized data integrity to maintain confidentiality, ensure appropriate use, and collect only the minimum necessary data. At the time, all trial records were paper-based and activities were conducted in person, long before electronic health records (EHRs), e-diaries, and other digital tools became commonplace.

According to Claire Riches, VP of Clinical Solutions at Citeline, these technological advancements prompted the update, making the guideline “fit for purpose” in today’s clinical research environment, with a greater focus on risk assessment and proportionality.