The core international guideline on good clinical practice is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH GCP E6). While other ICH guidelines (such as ICH E8 and ICH E11) offer complementary guidance for clinical trials or specific populations, ICH GCP E6 remains the primary and authoritative GCP framework. Since ICH GCP E6 was first published in 1996, clinical trials have become much more complex and technology has advanced considerably. The third version (R3) not only responds to these developments, but it also represents a fundamental shift from one-size-fits-all guidelines to a more nuanced and adaptive governance model. This article looks into the background of ICH GCP E6 and the driving factors of the third version, lists key updates, and dives into the impacts of the revision, especially on investigators, sponsors, and data governance. The article concludes with a key takeaway: clinical research professionals will need to remain flexible and keep a proactive mindset as they put ICH GCP E6(R3) into practice.
Fanny Muet (Mon,) studied this question.