RCR: ICH E6(R3) Annex 2: GCP for Trial Methodologies, Today and Tomorrow

Presented by Shirley Longinotti, BA, Research Education Facilitator 

The International Council for Harmonisation (ICH) was assembled to reduce divergence in regulatory and technical requirements across countries. Harmonized guidelines on Quality, Safety, and Efficacy—along with common terminology and data standards—support consistent global expectations followed by FDA, NIH, and international sponsors. 

This session spotlights the ICH E6(R3) revision with a dedicated focus on Annex 2, which provides additional GCP considerations for diverse interventional trial designs such as:  

• Pragmatic trials that embed research in routine care settings 

• Decentralized and hybrid trials leveraging emerging technologies 

• Studies that generate or leverage Real-World Data and Real-World Evidence  

Annex 2 guides day‑to‑day GCP decisions on pragmatic and decentralized designs, vendor and DHT oversight, credible use of RWD/RWE, and inspection‑ready monitoring and records