E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the participation of human
subjects. Compliance with this standard provides public assurance that the rights, safety, and
well-being of trial subjects are protected, consistent with the principles that have their origin
in the Declaration of Helsinki, and that the clinical trial data are credible.
The objective of this ICH GCP guidance is to provide a unified standard for the European Union,
Japan, and the United States to facilitate the mutual acceptance of clinical data by the
regulatory authorities in these jurisdictions.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
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-2018-D-0719.