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

Report to IRB?

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
  • 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
Owner:Molly L.Group:SMPH Research Informatics
Created:2020-03-25 12:56 CSTUpdated:2022-10-05 09:10 CST
Sites:Institute for Clinical and Translational Research, SMPH Research Informatics
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