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Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 -: Difference between revisions

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|content=This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
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== Content ==
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

Latest revision as of 13:49, 16 July 2026



Document information
Reference USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1):

Guidance for Industry March 2018

Validity area USA
Scope(s) G
Document name FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1):

Guidance for Industry

Version / Revision March 2018
Status Current
Document type Official recommendation
Language(s) EN
Description GUIDANCE DOCUMENT

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

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 1 — Unit 1.3.0
Scope G
Document part -
Language EN
Original entry by Florian Adragna
Contributors
Tags Good clinical practice, FDA, Clinical trial

Content

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

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