Completing The Unanticipated Problem And/Or Noncompliance Reporting Worksheet
This Quickguide provides instructions for completing the Unanticipated Problem and/or the Noncompliance Reporting Worksheet.
BEFORE YOU BEGIN
- Consider printing a copy of the Worksheet by clicking here to use as reference as you complete the Worksheet in IRBManager.
- The Worksheet should be completed by the Principal Investigator (PI) or PI’s designee.
- First, determine whether the incident is a potential unanticipated problem (UP). For more information, go to Algorithm to Assess a Potential Unanticipated Problem.
- Next, assess whether the incident is potentially serious or reflects continuing noncompliance. For more information, go to Algorithm to Assess Potential Noncompliance.
- If you are at an NCI Division of Cancer Prevention (DCP) Consortia or CP-CTNet site and don’t currently have an account to access IRBManager, go to Navigating The CIRB For NCI Division of Cancer Prevention Consortia Sites And Cancer Prevention Clinical Trial Network (CP-CTNet) Organizations for information on how the account process varies for you.
If the incident is a potential or unanticipated problem or a noncompliance issue, the PI or designee answers all questions on the Worksheet. Details about each question on the Worksheet follows.
COMPLETE THE SIGNATORY INSTITUTION INFORMATION QUESTION
- The submitting user information is auto-populated. Use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to change the auto-populated information relating to the person submitting and the name of the institution. For more information, go to Updating Your CIRB Person Roster Using RUMS.
COMPLETE THE GENERAL INFORMATION QUESTIONS
- Question 1: An incident is generally associated with one study, so enter this study ID. In the rare circumstances when an incident affects more than one study you’ll enter one primary study, with the others listed in the text box below the primary study.
- Question 2: Indicate the PI associated with the study being reported on this Worksheet. The email address entered must be the one associated with the PI in the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS).
- Question 3: The CIRB needs to know the Protocol Version Date associated with the incident occurrence. This may not be the most current version of the study. Enter the Protocol Version Date associated with the study. In the case of multiple studies, enter each study’s Protocol Version Date.
- Question 4: All unique registration numbers of the study participants affected by the incident should be listed.
NOTE: Incidents involving a single study and multiple study participants should always report using a single Worksheet.
COMPLETE THE DESCRIPTON OF INCIDENT, EXPERIENCE, OR OUTCOME QUESTIONS
- Question 1: Enter the date the incident occurred. If that is different from the date that the incident was identified, then include both dates.
- Question 2: Describe the incident in as much detail as possible.
NOTE: If the event is due to COVID-19:
- Minor deviations
- Per NCI guidance, minor protocol deviations should be reported to the organization leading the trial (LPO) so the LPO can report them to the NCI CIRB at time of continuing review.
- Major deviations
- Per CIRB guidelines, submit if it is a potential UP or SCN and attach any approved study-specific COVID-19 memos.
- Question 3: Indicate “Yes” if there has been any correspondence with the Study Chair, Network, or NCI and attach a copy. This includes Adverse Event Reporting System (AERS) reports for serious adverse events that are being reported as potential unanticipated problems; and any study data that has been reported via Electronic Data Capture (EDC) as part of routine study reporting..
- Question 4: Indicate the type of report submission, Unanticipated Problem or Serious or Continuing Noncompliance. If the incident occurred when following protocol procedures as written and complete the Potential Unanticipated Problem report. If the incident occurred due to a deviation from the protocol, the type of report would be the Serious or Continuing Noncompliance.
COMPLETE THE POTENTIAL UNANTICIPATED PROBLEM QUESTIONS
- NOTE: The first three questions of this section reflect the definition of an unanticipated problem per the Office for Human Research Protections guidance. If one of the answers is “No,” then the incident is not reportable.
- Question 1: Indicate “Yes” if this incident is unexpected and enter the date the incident occurred. If the date of the incident occurrence is different from the date it was identified, then include both dates.
- Question 2: Indicate “Yes” and describe how the incident is related or possibly related to the research. For example, if the incident is related to disease progression then it is not due to participation in research. Any attachments describing the incident or supporting the timeline of the incident should be attached.
- Question 3: Indicate “Yes,” and describe how the incident placed the study participant(s) or others at a greater risk of harm.
- Question 4: Describe actions taken as a result of the incident.
NOTE: Many of the questions allow inclusion of supporting documentation.
COMPLETE THE POTENTIAL SERIOUS OR CONTINUING NONCOMPLIANCE REPORT QUESTIONS
- Question 1: If the incident meets the definition of serious noncompliance, indicate “Yes,” and state how the definition is met.
- Question 2: If the incident meets the definition of continuing noncompliance, indicate “Yes,” and state how the definition is met.
- Question 3: Describe the impact of the incident on study participant(s) continued participation in the research. If study participant(s) are removed from study, provide the details.
- Question 4: The PI and/or research team must submit a management plan to address the noncompliance. This plan must be submitted at the time of this report. If this incident is identified during an audit, the auditing body should review and approve the management plan prior to submitting to the CIRB.