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 Withdrawn: The regulatory item was submitted to the IRB in error, PI decides to abandon the study, study closes, or no longer applicable to the study.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 |