FDA: E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

Guidance for Industry


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.

The guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization.

This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.

The principles established in this guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.

To view the complete document, posted by the FDA, click the link below

FDA UCM464506

This document was originally posted by the FDA here