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GUIDANCE DOCUMENT

E6(R3) Good Clinical Practice: Annex 2 December 2024

Download the Draft Guidance Document
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-5601
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Good Clinical Practice:  Annex 2.”  The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).  The draft guidance is the second annex to “E6(R3) Good Clinical Practice” published June of 2023.  This annex provides additional considerations for the application of good clinical practices to a variety of trial designs and data sources.  Specifically, this draft guidance discusses trials with decentralized and pragmatic elements and real-world data sources.  This draft guidance highlights the importance of quality by design and focusing efforts and resources on critical aspects of the trials that might impact the safety of participants and the reliability of results.  The draft guidance is intended to encourage innovation in trial design and provides flexible, modern, and clear good clinical practices for conducting trials, while avoiding unnecessary complexities.

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All written comments should be identified with this document's docket number: FDA-2024-D-5601.

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