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ICH GCP E6 (R2): Updates to clinical practice guidelines

 
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ICH GCP E6 (R2): Updates to clinical practice guidelines
by System Administrator - Sunday, 17 April 2016, 8:05 AM
 

Changes were done in ICH E6 R1 GCP in following sections:

Integrated Addendum to ICH E6(R1) document. Changes are integrated directly into the following sections of the parental Guideline: Introduction, 1.11.1, 1.38.1, 1.39, 1.60.1, 2.10, 4.2.5, 4.2.6, 4.9.0, 5.0, 5.0.1, 5.0.2, 5.0.3, 5.0.4, 5.0.5, 5.0.6, 5.0.7, 5.2.1, 5.2.2, 5.5.3 (b), 5.5.3 (h), 5.18.3, 5.18.6 (e), 5.18.7, 5.20.1, 8.1


Please see following link for more details :

http://cyntegrity.com/how-the-new-gcp-addendum-influences-clinical-monitoring/

Download PDF

1. GCP Addendum mindmap Ver 2.0

2. ICH E6 (R2) Revised GCP