Incidents of noncompliance that have a basis in fact must be reported to the ORA by submission of a Protocol Violation Report. This form can be found under the "Miscellaneous" heading on the FORMS page and in the online system (see instruction manual). The PI is responsible for ensuring that the required reports are submitted within five (5) business days following discovery of the incident.
Once the form is received, it will be reviewed and processed by the IRB Compliance Coordinator who will, in consultation with the IRB Executive Chair if necessary, review the violation and approve the corrective action plan. Violations that are considered more than minor must go to the Full Board for review.
