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

Review Reason

Field Name Definition Requirement
Entry Instructions
QA
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


KeywordsIRB Review Reason   Doc ID101849
OwnerMolly H.GroupSMPH Research Informatics
Created2020-05-08 10:41:00Updated2022-10-05 10:10:15
SitesInstitute for Clinical and Translational Research, SMPH Research Informatics
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