Investigators must notify the IACUC regarding any unanticipated deaths, adverse events, unexpected study results or a phenotype that negatively impacts the welfare of an animal. Notification must still occur even if the issue has been identified and corrected. Notification must be timely, to minimize the effect on animal welfare.
A protocol deviation is any departure from methods approved in an IACUC protocol. Examples of protocol deviations include, but are not limited to: Failure to follow written IACUC protocol procedures, failure to obtain IACUC approval for a change in the research design, failure to report a known adverse event to the IACUC.
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. Serious events (by definition) should be reported by the PI within 24 hours, while non-serious events are to be reported within 5 days of learning 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 IACUC 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 IACUC Coordinator via email. The IACUC Office will later import the contents of the form into the TOPAZ system on your behalf.