Informed Consent Document Review [Regulatives / Guidelines]

posted by WhiteCoatWriter – India, 2019-12-11 19:36 (722 d 06:05 ago) – Posting: # 20972
Views: 1,380

» 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)

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