written consent from volunteers [GxP / QC / QA]

posted by suchit_bhavsar – India, 2017-04-14 10:30 (2926 d 23:50 ago) – Posting: # 17238
Views: 3,936

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]

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,703 registered users;
26 visitors (0 registered, 26 guests [including 5 identified bots]).
Forum time: 10:21 CEST (Europe/Vienna)

Do not put your faith in what statistics say until you have carefully
considered what they do not say.    William W. Watt

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5