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Aug 31, 2016

An addendum to ICH-GCP released..

To see the addendum go to: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf

or download from here..

Revised Sections:

1.       Quality Management

2.       Centralized Monitoring

3.       Study Oversight

4.       SOPs for Electronic Systems

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