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arrow Report A Potential Unanticipated Problem Or A Serious Or Continuing Noncompliance

Reporting Audit Findings

OVERVIEW

This Quickguide provides instructions for reporting audit findings to the CIRB as potential serious or continuing noncompliance.  

BEFORE YOU BEGIN

  • Collect the audit report, the response to the audit report, and the management plan that outlines how the findings will be addressed and future occurrences prevented.
Report Audit Findings graphic

STEPS

Steps

PI OR DESIGNEE REVIEWS AUDIT REPORT

The Principal Investigator (PI) or designee reviews the audit report issued by the institution, a Network, the Office for Human Research Protections (OHRP), or the Food and Drug Administration (FDA) for a study open under the CIRB.

Steps

PI OR DESIGNEE IDENTIFIES MAJOR AUDIT FINDINGS

There are two categories of audit findings: major and minor. Any major finding based on the Clinical Trials Monitoring Branch audit guidelines should be submitted to the CIRB as potential serious noncompliance. Any finding that had been documented in a previous audit report should be submitted to the CIRB as potential continuing noncompliance.

Steps

PI OR DESIGNEE COMPLETES THE UNANTICIPATED PROBLEM AND/OR NONCOMPLIANCE WORKSHEET

The PI or designee submits any findings (potential serious or continuing noncompliance) using the Unanticipated Problem and/or Noncompliance Worksheet available in IRBManager. For more information, go to the Completing the Unanticipated Problem and/or the Noncompliance Reporting Worksheet.

Steps

CIRB OPERATIONS OFFICE CONDUCTS ADMINISTRATIVE REVIEW

The Worksheet is reviewed by the CIRB Operations Office. This review typically takes two weeks. The CIRB Operations Office may send the submitter an email request for additional information. Revisions to the Worksheet are completed in IRBManager.

Steps

CIRB LOCAL CONTEXT COMMITTEE CONDUCTS REVIEW

After the administrative review, the Worksheet is sent to the CIRB Local Context Subcommittee for review. This process typically takes five days. The CIRB Operations Office may send the submitter an email request for additional information. Revisions to the Worksheet are completed in IRBManager.

Steps

CIRB SENDS DETERMINATION LETTER TO INSTITUTION

After the CIRB Local Context Subcommittee approves the Worksheet, the CIRB Operations Office sends a determination letter to:

  • the PI
  • the person submitting the Worksheet,
  • the Signatory Institution Primary Contact(s), and
  • OHRP and FDA if the event is determined to be reportable.

USEFUL TIP

You can usually expect to receive the determination letter within a month of submitting the Unanticipated Problem and/or Noncompliance Worksheet. If the submission is incomplete or if there are questions raised during the administrative or local context review, the process will take longer.

 

 

Posted: June 15, 2017