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GUIDANCE DOCUMENT

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

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Good Clinical Practice:  Annex 2.”  The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).  The draft guidance is the second annex to “E6(R3) Good Clinical Practice” published June of 2023.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  Specifically, this draft guidance discusses trials with decentralized and pragmatic elements and real-world data sources.  This draft guidance highlights the importance of quality by design and focusing efforts and resources on critical aspects of the trials that might impact the safety of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  The draft guidance is intended to encourage innovation in trial design and provides flexible, modern, and clear good clinical practices for conducting trials, while avoiding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