Remove tag annex-1
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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Rethinking Clinical Trials

Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources. The current 11 ICH principles are generally sound, and the structure of Introduction > Principles > Annexes support critical application.

article thumbnail

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Rethinking Clinical Trials

Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources. The current 11 ICH principles are generally sound, and the structure of Introduction > Principles > Annexes support critical application.