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

IRB: Action

Field Name Definition Requirement
Entry Instructions
QA
Action The decision of the IRB in regards to the regulatory item:
Approved: The IRB grants permission to commence or continue the research. When the Action is marked “Approved” the following occurs:
Initial (protocol) Review: The protocol status changes to “Initial IRB Approval” in the header and the PC Console > Status Tab.
Change Review/Consent Form: The approved new version date, description, and expiration date of the consent form populates to Subject Console > Consent Tab and the PC Console > Institution > Consent Forms Tab.
Exempt: Utilized when study is IRB exempt and does not require IRB approval. Note: An initial review with an action of ‘Exempt’ will change the status of the protocol to IRB Initial Approval.
Disapproved: The IRB does not grant permission to commence or continue the research and the research must stop.
Acknowledged: Utilized when regulatory items are submitted to the IRB for informational purposes only and a response is not necessarily required.
Withdrawn: The regulatory item was submitted to the IRB in error, PI decides to abandon the study, study closes, or no longer applicable to the study.
Defer: Significant issues with the study. Resubmission required.
Required No




Keywords:Action IRB   Doc ID:101852
Owner:Molly L.Group:SMPH Research Informatics
Created:2020-05-08 09:44 CSTUpdated:2022-10-05 09:10 CST
Sites:Institute for Clinical and Translational Research, SMPH Research Informatics
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