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written consent from volunteers [GxP / QC / QA]

posted by suchit_bhavsar - India, 2017-04-14 06:30  - Posting: # 17238
Views: 454

Hello to all of you.

As per ICH GCP E6, section No. 4.8.2 "Any revised written informed consent form, and written information should receive the IRB/IEC's approval/favorable opinion in advance of use"

Is it required to get screening consent approved from Ethic committee before starting of the screening (in case of general screening)

Thanks in advance

Regards,
Suchit Bhavsar


Edit: Category changed; see also this post #1. [Helmut]

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