ICH E6(R3) Annex 2: Navigating GCP Requirements For Decentralized Trials

Sponsors and investigators are facing expanded accountability under newly established GCP standards — one that reaches into vendor contracts, third-party data sources, and multi-stream safety oversight. Rather than replacing core GCP principles, the adoption of ICH E6(R3) Annex 2 introduces targeted standards for data governance, remote consent, and multi-source investigator oversight. Sponsors face expanded accountability for securing individual-level RWD access for quality assurance and regulatory inspections, even when data resides with third-party healthcare providers. Simultaneously, investigators must maintain unified, timely oversight across diverse safety streams to satisfy compliance standards.

Understanding these operational shifts is essential for aligning trial protocols, vendor contracts, and data management systems before regulatory submission. Access the complete insight brief to ensure your clinical trials meet the latest GCP frameworks.