Do sites need to submit reports of adverse events, minor protocol deviations or other minor problems to Quorum Review?
As a general rule, no. Examples of events that generally do not need to be reported to Quorum include:
- Adverse events that, in the PI’s judgment, are not related to the study (such as a participant catching the flu);
- Adverse events that are anticipated or expected as part of the study (such as nausea in a trial of a chemotherapy drug);
- IND Safety Reports that, in the PI’s judgment, do not adversely affect the conduct of the PI’s study at his/her research facility;
- Minor protocol deviations (such as study visits performed slightly out of window);
- Minor research participant complaints that are adequately resolved by the research staff.
At the time of periodic site review, Quorum Review IRB’s “Sites Status Report for Periodic Site Review” will ask whether the investigator believes that a change in the research plan or the consent form is necessary in light of these unreported events. If the investigator recommends a change in the research or the consent form, Quorum Review IRB might request that the investigator submit the log or other summary of adverse events and protocol deviations for further consideration.