What ICH E6(R3) Good Clinical Practice Revision 2023 - Risk-Proportionate Approaches, Decentralised Trials, Remote Monitoring and Data Integrity Standards requires
This regulation requires sponsors to implement risk-proportionate approaches to clinical trials, as outlined in Article 1.61, and to ensure data integrity, as specified in Article 1.62. It applies to all clinical trials conducted in the pharmaceutical industry.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.1 · Last updated:
Primary source: https://www.ich.org/page/efficacy-guidelines
SHA-256 integrity: af606eed5271d30fe5f10ca12d2a7f42c3bcab514b25d3bf6a3e66f53a3d4f9b
Primary Citations — 7 traced to source
- ICH E6(R3), Article 1.61 - Risk-Proportionate Approaches
- ICH E6(R3), Article 1.62 - Decentralised Trials, Remote Monitoring and Data Integrity Standards
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