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  5. Guidance on Closure of Human Subject Research Studies
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Guidance on Closure of Human Subject Research Studies

A completion report is required for all human subject studies. The closure report updates the IRB on the conduct and the outcomes of the study, any new risks, safety issues or problems that may have arisen since the last study renewal, and informs the IRB of the final disposition of research records and data.

Completion reports should be submitted to the IRB within 30 days of study completion by completing the IRB-2 Re-Approval/Completion report application in InfoEd. Note: The PI does not have to wait for the end of the study approval period to submit a completion report.

If any of the following six conditions apply do not file a completion report. Such studies must remain active and continue to receive ongoing IRB review and approval:

  1. Enrollment is on-going.
  2. Research-related interventions and/or follow-up is ongoing.
  3. Participant follow-up is ongoing.
  4. Biological specimens containing personally identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research is ongoing. If, however, specimens were transferred to a separate repository that has ongoing IRB approval, the study may be closed.
  5. Data analysis or manuscript preparation that involves the use or access to personally identifiable information is ongoing.
  6. If there is an external study sponsor and the sponsor has not provided permission to close the study with the IRB.

 

Report Study Completion Procedures

Complete the IRB-2 Re-Approval/Completion Form in InfoEd.

  • Provide the date the study was completed in the Status of Study section.
  • Provide a copy of the final DSMB report if applicable.
  • Provide a summary of the findings and provide copies of any publications or manuscripts resulting from the study.
  • Complete sections VI, VII, VII and IX, if applicable.

Record Retention

The IRB would like to remind investigators that data from the completed study should be stored and protected in the manner approved by the IRB and consented to by the research participant so as to maintain the privacy and confidentiality of the participants. Whenever possible, the data should be permanently de-identified. Also, at a minimum, per federal regulations (45 CFR 46.115(b) and 21 CFR 56.115(b)), investigators must maintain research records for three years beyond the completion/termination of the study. Investigators should be aware that other laws and requirements (e.g., funding agency) may require a longer record retention period.

Refer to the IRB’s record retention policy for additional guidance – https://ovpr.uconn.edu/irb/irb-policies-and-procedures-intro/record-retention/.

 

Serious Adverse Events or Unanticipated Problems Learned After Study Closure

The PI must report to the IRB any information learned after study closure that could affect participant safety or care, including but not limited to serious adverse events or unanticipated problems report by the Sponsor or other responsible for study monitoring.

 

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