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

Report to IRB? (SAE Tab)

Field Name Definition Requirement
Entry Instructions		 Responsible for Entry QA
Report to IRB? 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.
 Recommended

Select the timeframe in which the SAE will be reported to the IRB of record, if applicable.

 No

Keywords:
SAE report IRB
Doc ID:
99488
Owned by:
Ilsa G. in SMPH Research Applications
Created:
2020-03-25
Updated:
2026-01-14
Sites:
SMPH Research Applications