Informed Consent Document Review [Regulatives / Guidelines]

posted by WhiteCoatWriter – India, 2019-12-11 20:36 (1448 d 14:15 ago) – Posting: # 20972
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❝ Is there any window period for review of Informed Consent Document for BA/ BE study

If you mean, review period for a subject to read/review the ICD ?
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

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