Protocol Deviation Reporting

Protocol Deviation Information

A protocol deviation is an incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the subject’s rights, safety, or welfare, or on the integrity of the resultant data.

Examples of protocol deviations include, but are not limited to: Failure to follow written IRB protocol procedures, failure to use an IRB-approved consent form, failure to obtain IRB approval for a change in the research design, failure to report a known adverse event to the IRB.

Submitting an Protocol Deviation

Complete the Event Form (Interim Review Form), which is accessible within the online TOPAZ Electronic Protocol Submission System. The Event Form is used for reporting both Adverse Events and Protocol Deviations

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment, Renewal, or Event Report for the same project). For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Protocol Deviation, it is advised to first contact the IRB Office to see if your pending submission is almost ready for approval. If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IRB Coordinator via email. The IRB Office will later import the contents of the form into the TOPAZ system on your behalf.