ICH Good Clinical Practice E6 (R3)

The ICH guideline for Good Clinical Practice (GCP) is the revised and modernised successor to ICH E6(R2), establishing an international standard for the design, conduct, recording and reporting of clinical trials involving human participants. It defines the responsibilities of sponsors, investigators and other parties to protect participants’ rights, safety and well‑being and to ensure the integrity and credibility of clinical trial data. The guideline supports global acceptance of clinical trial results by regulatory authorities across ICH regions.
Revised ICH E6(R3) is structured as:

• Overarching principles and objectives document – sets Good Clinical Practice principles that apply across clinical trial types and settings, promoting proportionate, risk‑based and innovation‑friendly approaches to trial design, conduct and oversight.
• Annex 1 – Interventional clinical trials – provides detailed guidance on how to apply the principles to interventional clinical trials and serves as the operational replacement for ICH E6(R2).
• Annex 2 – Additional considerations for non‑traditional interventional clinical trials – offers Good Clinical Practice considerations for designs such as pragmatic and decentralised clinical trials and those using real‑world data sources.