When should sites report a protocol deviation to Quorum?
Quorum Review IRB requires sites to report only major protocol deviations. A “major” protocol deviation is a protocol deviation that adversely affects the:
- Safety or welfare of research participants or others;
- Rights of research participants or others; or
- Integrity of the study design
Investigators must report a major protocol deviation to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence. Please use Quorum Review IRB’s Major Protocol Deviation Report form.