Topics Map > OnCore > Data Field Definitions > Non-oncology

Review Reason

Field Name Definition Requirement
Entry Instructions
Review Reason The reason the regulatory item is being reviewed by the IRB:
Initial Review: For new studies.
Continuing Review: Re-approval for a study, typically annually
Change Review: For changes to protocol, consent, IDB, PI, or IRB application.
Personnel Change: When personnel is added to the IRB application.
Reportable Event: When an event occurs that requires reporting to the IRB.
Protocol Closure: For completed protocols where all subjects are off study and all data is locked down. Requires an official closure letter from the sponsor if an external study.
Required No

Keywords:IRB Review Reason   Doc ID:101849
Owner:Molly L.Group:SMPH Research Informatics
Created:2020-05-08 09:41 CSTUpdated:2022-10-05 09:10 CST
Sites:Institute for Clinical and Translational Research, SMPH Research Informatics
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