Adverse Event Information
Investigators must notify the IBC regarding any adverse events. Notification must still occur even if the issue has been identified and corrected. The PI is responsible for reporting serious unanticipated events within 24 hours, and non-serious events within 5 days of the occurrence
Protocol Deviation Information
A protocol deviation is any departure from methods approved in an IBC protocol. Examples of protocol deviations include, but are not limited to: Failure to follow written IBC protocol procedures, failure to obtain IBC approval for a change in the research design, failure to report a known adverse event to the IBC.
Submitting an Adverse Event
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. The PI is responsible for reporting serious unanticipated events within 24 hours, and non-serious events within 5 days of the occurrence.
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 Adverse Event or Problem, it is advised to first contact the IBC 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 IBC Coordinator via email. The IBC Office will later import the contents of the form into the TOPAZ system on your behalf.