Algorithm to Assess a Potential Unanticipated Problem
OVERVIEW
This Quickguide provides an algorithm to assess whether or not an incident is reportable to the CIRB as a potential unanticipated problem.
BEFORE YOU BEGIN
- 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.
INSTRUCTIONS
- Review the following algorithm. If all answers are “Yes” or if the PI and research team are uncertain, the incident should be reported to the CIRB as a potential unanticipated problem. For more information, go to Completing the Unanticipated Problem and/or Noncompliance Reporting Worksheet.
