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suchit_bhavsar ★ India, 2019-12-11 12:22 (1589 d 20:23 ago) Posting: # 20970 Views: 2,347 |
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Hello to all of you Is there any window period for review of Informed Consent Document for BA/ BE study Regards, Suchit Bhavsar |
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Ohlbe ★★★ France, 2019-12-11 17:58 (1589 d 14:47 ago) @ suchit_bhavsar Posting: # 20971 Views: 1,714 |
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Dear Suchit, ❝ Is there any window period for review of Informed Consent Document for BA/ BE study Could you please explain what you mean by "review of Informed Consent Document" ? Review by who ? For what ? — Regards Ohlbe |
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WhiteCoatWriter ☆ India, 2019-12-11 20:36 (1589 d 12:10 ago) @ suchit_bhavsar Posting: # 20972 Views: 1,712 |
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❝ 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) |
Ing. Helmut Schütz