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

Introduction

The International Council for Harmonisation (ICH) has updated its Good Clinical Practice (GCP) guideline, effective July 23, 2025. ICH GCP is an international, ethical, scientific, and quality standard for the conduct of trials that involve human participants. Clinical trials conducted in accordance with this standard will help to assure that the rights, safety, and wellbeing of trial participants are protected; that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the clinical trial results are reliable.¹

Put in place 30 years ago, the guideline was designed to make patient safety paramount, says Claire Riches, Citeline VP of Clinical Solutions. She says data integrity was always a critical component of GCP, to ensure that confidentiality was maintained, that data were being used for the right purposes, and that the minimum data needed were collected. 

When the guideline was first put in place, Riches notes, everything was recorded on paper and conducted in person. There were no such things as electronic health records (EHR) or electronic diaries. Technological advancements such as these necessitated that the guideline be updated along the way. “The guideline was so out of date compared to what we have access to now,” Riches says. She adds that the latest update is fit for purpose on “how we run trials today and what we have access to,” with a focus on risk assessment and proportionality.

References

¹ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Available from: https:// database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf [Accessed Aug. 21, 2025].