Report to IRB?
Field Name | Definition | Requirement Entry Instructions |
QA |
---|---|---|---|
Reported to IRB? | Indicates if deviation was reported to IRB. Select the timeframe in which the deviation will be reported to the IRB, if applicable. Immediately: Select when a Reportable Event submission is/will be made to the IRB. Not Applicable: Select when IRB reporting is not required. |
Recommended | No |