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These laws and regulations are intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects.
The European Medicines Agency (EMA) provides guidance in forms of questions and answers (Q&As) on good clinical practice (GCP), as discussed and agreed by the GCP Inspectors Working Group.
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.
Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD).”
Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025.
In support of ICH E6 (R3), which recently gained ICH approval but is not yet endorsed by regulators, the FDA has published draft guidance titled E6 (R3) Good Clinical Practice: Annex 2, which emphasizes the importance...
Local HCPs are a valuable resource for decentralized trials. However, in the Annex 2 draft guideline, the use of local HCPs in decentralized trials is referenced in just one sentence: “Healthcare professionals may be ...
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects.
Experts already speculate on “GCP 4.0”: as trials incorporate digital biomarkers, decentralized data, and even patient-led research, the next revision may address areas like real-world evidence integration or gene the...
The ICH E6 (R3) Good Clinical Practice (GCP) Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by competent regulatory authorities.
