A major update is coming to Good Clinical Practice (GCP) guidelines: the International Council for Harmonisation (ICH) will soon release its draft E6(R3) Annex 2, designed to address non-traditional trial designs and further support risk-based monitoring. This long-anticipated addition builds on the core principles introduced in E6(R3) and reflects the evolving complexity of clinical research.
Read our article now to learn:
- The purpose and scope of ICH E6(R3) Annex 2
- Why it’s a pivotal step for adaptive and decentralized trials
- What research teams can do now to prepare
