What should a site do if a sponsor’s reporting guidelines require the submission of all serious adverse events and major protocol deviations even if they do not meet Quorum’s reporting criteria?

Quorum Review IRB recognizes that sponsors, site monitors, CROs or sites may have broader reporting requirements than Quorum’s. You can go ahead and submit such reports. Quorum Review IRB will provide a standard acknowledgement of all documents submitted to fulfill such sponsor and site requirements.