Does the IRB require submission and review of Manuals for Procedures

Frequently Asked Question

Manuals for Procedures (MOPs) are often issued by study sponsors or coordinating centers to describe study procedures in more detail than what is typically provided in the protocol. MOPs, including any subsequent revisions to the MOP, should be submitted to the IRB only if they contain information about procedures involving human subjects that is not found in any other protocol document, including the ARROW application, protocol, consent documents, or investigator drug brochures. Changes in technical study procedures do not need to be submitted.

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Keywords:FAQ, manual for procedures, MOPs   Doc ID:26808
Owner:Monica E.Group:Health Sciences IRBs
Created:2012-10-12 11:49 CSTUpdated:2016-12-19 09:28 CST
Sites:Health Sciences IRBs
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