Algorithm to Assess Potential Noncompliance

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.

 

USEFUL TIPS

  • 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 the event is not serious noncompliance, similar incidents in the future do not need to be reported to the CIRB. They are still noncompliant, but not reportable noncompliant.

 

 

Posted: June 15, 2017