Reportable Events

IRB Review Process | External IRB Review Process | Consent Process | Protocol Modifications | Reportable Events | Human Subject Educational Training Requirement | IRB Submission | IRB Submission Deadline

How do I report a protocol deviation or violation to the IRB?

The principal investigator should promptly report to the IRB a protocol deviation or violation within 10 business days of when the event was discovered by sending in a signed memo (PI) describing the event AND a completed Protocol Violation Reporting Form (see “Forms”). The memo should also include a corrective plan or solution for preventing such event from occurring again. The protocol deviation or violation will be reported to the convened board for consideration and review regardless of the type of category originally approved under. Any board findings or notifications will be sent to the principal investigator.

For more guidance on this topic, please visit the “Guidance” portion of our website or click here.