Considerations When Transfering Clinical Investigation Oversight to Another irb

Contains Nonbinding Recommendations 

 

 

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appropriate institutional officials, and FDA.

32, 33

  FDA recommends that sponsors also be 

informed of any suspension or termination and the reasons for such action.

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 Informing sponsors 

of an IRB suspension or termination of the study allows sponsors the opportunity to address the 

IRB’s concerns so that disruptions of the study can be minimized and any human subject 

protection issues can be addressed. 

 

Sponsors must also report such information to FDA.  Sponsors of drug/biologic studies are 

required under 21 CFR 312.31(a)(2) to report to FDA any information regarding the 

discontinuation of a clinical investigation in an information amendment to the Investigational 

New Drug (IND) application.  Sponsors of device studies are required under 21 CFR 

812.150(b)(2) to notify FDA and all reviewing IRBs and participating investigators of any 

withdrawal of IRB approval of an investigation or a part of an investigation within 5 working 

days after receipt of the withdrawal.