suchit_bhavsar
★    

India,
2017-04-14 10:30
(3337 d 17:48 ago)

Posting: # 17238
Views: 5,374
 

 written consent from volunteers [GxP / QC / QA]

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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
(3337 d 08:02 ago)

@ suchit_bhavsar
Posting: # 17240
Views: 4,166
 

 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
 
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