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]
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:
- written consent from volunteerssuchit_bhavsar 2017-04-14 08:30 [GxP / QC / QA]
- written consent from volunteers Ohlbe 2017-04-14 18:17