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Back to the forum  Query: 2017-12-13 08:28 CET (UTC+1h)
 
suchit_bhavsar
Regular

India,
2017-04-14 08:30

Posting: # 17238
Views: 791
 

 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
Hero

France,
2017-04-14 18:17

@ suchit_bhavsar
Posting: # 17240
Views: 627
 

 written consent from volunteers

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
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