Algorithm to Assess a Potential Unanticipated Problem


This Quickguide provides an algorithm to assess whether or not an incident is reportable to the CIRB as a potential unanticipated problem.


  • While reviewing the algorithm to assess a potential unanticipated problem, the CIRB defines “unexpected” as incidents, experiences, or outcomes that occur while the CIRB-approved protocol is followed as written. These events are unexpected as they are not included in the CIRB-approved protocol, CIRB-approved informed consent document, or the Investigator's Brochure.


Reporting Algorithm graphic


  • If you are uncertain about whether or not to report an incident, you should proceed with reporting it to the CIRB. If the determination by the CIRB is that it is not an unanticipated problem, similar incidents in the future do not need to be reported to the CIRB.



Posted: June 15, 2017