Bioequivalence and Bioavailability Forum • written consent from volunteers

suchit_bhavsar
★

India,
2017-04-14 10:30
(2561 d 17:59 ago)

Posting: # 17238
Views: 3,108

written consent from volunteers [GxP / QC / QA]

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]

Ohlbe ★★★ France, 2017-04-14 20:17 (2561 d 08:13 ago) @ suchit_bhavsar Posting: # 17240 Views: 2,403	written consent from volunteers Post reply
	Dear Suchit, ❝ Is it required to get screening consent approved from Ethic committee before starting of the screening (in case of general screening) Clearly: yes. — Regards Ohlbe