Protocol Deviations & Adverse Events

Incident Reporting: Protocol Deviations and Adverse Events 

Sometimes, departures can occur from the procedures described in an IRB-approved protocol. Various terms are used to describe these departures, including “protocol deviations,” “protocol violations,” “protocol variances,” and “non-compliance.” We will refer to all of these departures with the term "protocol deviation." 

Other times, even when the approved protocol is followed exactly, problems may arise on that 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.  These problems will be described as "adverse events." 

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

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

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

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