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