suchit_bhavsar
★    

India,
2019-12-11 11:22
(552 d 21:29 ago)

Posting: # 20970
Views: 1,852
 

 Informed Consent Document Review [Regulatives / Guidelines]

Hello to all of you

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

Regards,
Suchit Bhavsar
Ohlbe
★★★

France,
2019-12-11 16:58
(552 d 15:54 ago)

@ suchit_bhavsar
Posting: # 20971
Views: 1,307
 

 Informed Consent Document Review

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
WhiteCoatWriter
☆    

India,
2019-12-11 19:36
(552 d 13:16 ago)

@ suchit_bhavsar
Posting: # 20972
Views: 1,306
 

 Informed Consent Document Review

» 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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