吉祥坊

Incident Reporting: Protocol Deviations and Adverse Events听

Sometimes, departures can occur from the procedures described in an IRB-approved protocol. Various terms are used to describe these departures, including 鈥減rotocol deviations,鈥� 鈥減rotocol violations,鈥� 鈥減rotocol variances,鈥� and 鈥渘on-compliance.鈥澨齏e will听refer to all of these departures with the term "protocol deviation."听

Other times, even when the approved protocol is followed exactly, problems may arise on鈥痶hat involve risks to human subjects. These problems may be anticipated or unanticipated, and they may be related or unrelated to participation in the research study.鈥� These problems will be听described as听"adverse events."听

1)听Incidents that occurred听on听research听that was听initially submitted in Cayuse:听 These studies will have an IRB number in the format: IRB-FY19-###听

Please use the Cayuse Native听incident reporting听process.听 Log into听Cayuse IRB听and enter the Study Details section for your study.听 On the top-right of the page will be a blue button that says 鈥�+ New Submission鈥�.听 Click on this and chose 鈥淚ncident鈥�, and then complete the submission form, submit and certify.听听听

2)听Incidents that occurred on protocols听that were previously approved on听PDF:听These studies will have an IRB number in the format 1718-###-x听

Email听irb@csun.edu听with a brief description of the protocol deviation or adverse event, and we will send you the forms to report the incident.听