Review Reason (Reviews IRB Tab)
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | 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 | Regulatory Coordinator | No |