Informed Consent Document Review [Regulatives / Guidelines]

posted by WhiteCoatWriter – India, 2019-12-11 19:36 (238 d 19:13 ago) – Posting: # 20972
Views: 927

» 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:

Activity
 Admin contact
20,969 posts in 4,374 threads, 1,460 registered users;
online 26 (2 registered, 24 guests [including 15 identified bots]).
Forum time: Thursday 15:49 CEST (Europe/Vienna)

It is a good morning exercise for a research scientist
to discard a pet hypothesis every day before breakfast.
It keeps him young.    Konrad Lorenz

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