OVERVIEW
This Quickguide provides an algorithm to assess whether or not an incident is reportable to the CIRB as potential noncompliance.
BEFORE YOU BEGIN
- While reviewing the algorithm to assess potential noncompliance, the CIRB defines “serious” as noncompliance that adversely affects the rights and welfare of study participants or results in any untoward medical occurrence that meets the criteria of “serious” or significantly impacts the integrity of study data. “Serious” is also defined as side effects that may require hospitalization or may be irreversible, long-term, life-threatening, or fatal.
INSTRUCTIONS
- Review the following algorithm. If any of the questions are answered “No” or if the PI and research team are uncertain, the incident may be in noncompliance. Continue to the questions related to determining whether the incident is serious. If the incident is potentially serious, it should be reported to the CIRB. For more information, go to Completing the Unanticipated Problem and/or Noncompliance Reporting Worksheet.
- The incident should be reported to the CIRB if you are directed by the Group to report.
