Report to IRB? (SAE Tab)

Field Name Definition Requirement
Entry Instructions		 QA
Report to IRB? Select the timeframe in which the SAE will be reported to the IRB of record, if applicable.. Recommended

Drop Down list options:
  • Not Applicable – use when reporting to IRB is not required
  • Immediately – use when IRB reporting is required within 24 to 48 hours of knowledge of the event.
  • Within X Business Days – use when IRB reporting is required by a defined number of business days other than 24-48 hours. Also note in the narrative when reporting is required. Example: Report to IRB within 14 business days.
  • Next Continuing Review – use when IRB reporting is required at continuing review.
 No

Keywords:
SAE report IRB 
Doc ID:
99488
Owned by:
Ilsa G. in SMPH Research Applications
Created:
2020-03-25
Updated:
2025-07-16
Sites:
SMPH Research Applications