When should sites report serious adverse events to Quorum?
Quorum Review IRB requires sites to submit reports of Serious Adverse Events (SAEs) that meet the criteria below:
- Unanticipated; and
- Related to the study product or study procedures.
If an adverse event meets all three requirements, it is a reportable SAE. An “unanticipated” adverse event is one that is not identified in nature, severity, or frequency in the relevant safety documents(s) for the study product or is not identified as a possible risk in the study protocol or the informed consent form for the study. Investigators must report an SAE to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence. Please use Quorum Review IRB’s Safety Information & UP Report form. An adverse event that does not meet all three reporting criteria listed above does not need to be reported to Quorum.