Informed Consent Document Review [Regulatives / Guidelines]

posted by WhiteCoatWriter – India, 2019-12-11 20:36 (1687 d 06:27 ago) – Posting: # 20972
Views: 1,971

❝ Is there any window period for review of Informed Consent Document for BA/ BE study


Hi,
If you mean, review period for a subject to read/review the ICD ?
Well,
Subject can take their own sweet time to review the ICD and take a decision if they want to participate in the study.

If you mean, review period for an Ethical committee ?
In that case, It could mostly be driven by SOP's and procedures laid down by the IEC/IRB in regard to the review/communication/meeting for protocol and protocol documents which are submitted to them.

Thanks and Regards
Dr Anonymous
(WhiteCoatWriter)

Complete thread:

UA Flag
Activity
 Admin contact
23,127 posts in 4,859 threads, 1,646 registered users;
36 visitors (0 registered, 36 guests [including 11 identified bots]).
Forum time: 04:03 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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