ICH E6 (R2) Good clinical practice

  • Email
  • Help
Current effective version

Revision 2 - Adopted guideline

 

Reference numberEMA/CHMP/ICH/135/1995
Published15/12/2016
Effective from14/06/2017
KeywordsGood clinical practice (GCP), Ethics Committee, Institutional Review Board, investigator, sponsor, protocol, investigator’s brochure, trial design, safety reporting, informed consent, statistics, clinical study/trial report
DescriptionThis document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.


Document history

Revision 2 

Current version

Adopted guideline

 

 

Draft guideline

Published: 15/12/2016

Effective from: 14/06/2017

 

Published: 04/08/2015

Revision 1

 

Adopted guideline

Published: 01/07/2002

 

In operation: 01/01/1997-14/06/2017

How helpful is this page?

Average rating:

 Based on 13 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
1 ratings
12 ratings
    

Tell us more