Study Closure

A study closure is required on all human subject research studies. Protocols should be closed in iRIS when the study has been completed, or when the only remaining activity is analysis of unidentifiable data. The closure report updates the IRB on the conduct and an outcome of the study, any new information captured since the last CAR and informs the IRB of the final disposition of the study records and data. The PI is responsible for reporting the completion of the protocol to the IRB within 30 days. 

Procedure for closing a study falls into five categories:

  • Project completion
  • Non-response from the PI to IRB requests for revisions at initial review;
  • Closure due to non-enrollment;
  • Lapse of approval due to non-response to requests for continuing review
  • PI or Sponsor initiates study withdrawal from the University site

Do not file a study closure if:

  • Enrollment at the site is ongoing,
  • Research related interventions, procedures and/ or follow-up is on-going,
  • Biological specimens containing PHI are being maintained in a repository (if the specimens have been transferred to another repository that has ongoing IRB approval- the study may be closed),
  • Maintaining identifiable data in a registry,
  • Data analysis involving the use of PHI is ongoing,

Project Completion

When a study is completed, the PI or Research Team Member completes an amendment form in iRIS and choose “study closure” as the amendment type. A final report should include the following information:

  • Summary of study findings
  • Any unreported UPIRTSOs (if applicable)
  • Final enrollment numbers (including withdrawals and reason for withdrawal)
  • Any subject complaints

Regardless of initial review type (full Board or expedited), protocols undergo administrative processing procedures for final review, unless the IRB analyst determines the circumstances surrounding the request for closure require a review by an IRB Chair/member. The study is considered officially closed on the day the IRB analyst or IRB Chair/member signs off on the study closure amendment.

Record Retention:

All data, including all signed consent form documents, must be retained for a minimum of three years past the completion of this research.  Additional requirements may b e imposed by the funding agency, University of Louisville department, or other entities.  Review UofL's Record Retention Policy.

IRB Responsibilities:

  • The IRB will provide investigators with a study completion letter.
  • If the IRB terminates a study (e.g. due to non-compliance) written notice detailing the IRB’s decision of termination will be provided to the investigator.
  • The IRB’s administrative termination of a study due to an expiration of IRB approval will be preceded by a reminder of the study’s expiration date followed by a 10 day post-expiration notice. If the PI fails to respond to the IRB requests, the study will be terminated. This is considered non-compliance with IRB/federal regulations and must be reported to Institutional officials, such as Department Chair, Dean, and EVPRI.
  • IRB study records will be stored and accessible for 3 years after study closure.

Reactivating IRB approval:

  • Under certain circumstances, the IRB will re-activate a research study previously closed. Please contact the HSPP office.
  • Re-activation may be subject to an IRB review fee.

SBE Study Closure Checklist

Access to identifiable information (e.g., as source documentation) is no longer needed by the research staff, sponsor or sponsor representatives.

All payments to subjects are complete.

PIs should submit a study closure amendment to the IRB within 30 days of completion or termination of all research activity.

Investigators must store the complete research records for a minimum of 3 years, in accordance with federal regulations, IRB policy, University of Louisville policy and any other additional requirements stipulated by the sponsor.  Records that are subject to HIPAA regulations shall be retained for at least 6 years after study completion.

The signed consents and HIPAA forms must be maintained, without alteration, for a minimum of 5 years to comply with the University’s Record Retention Policy.

If there is a request for subsequent data use from a closed research study, it requires IRB approval or an exemption from IRB review.

Commitments made such as the communication of research results or compensation to the subjects should be honored even if the study is terminated. These can be done for a terminated study with the permission of the IRB Chair or HSPPO Director.

When a principal investigator terminates employment or other association with the University, and there is not a qualified investigator to assume the role, then the current PI should close out the study.

Biomedical Study Closure Checklist

All outstanding data queries have been resolved or determined unresolvable.

Access to identifiable information (e.g., as source documentation) is no longer needed by the research staff, sponsor or sponsor representatives.

All payments to subjects and IRB fees are complete.

The clinicaltrials.gov website has been updated (if applicable).

PIs should submit a study closure amendment to the IRB within 30 days of completion or termination of all research activity.

Investigators must store the complete research records for a minimum of 3 years, in accordance with federal regulations, IRB policy, University of Louisville policy and any other additional requirements stipulated by the sponsor.  Records that are subject to HIPAA regulations shall be retained for at least 6 years after study completion.

The signed consents and HIPAA forms must be maintained, without alteration, for a minimum of 5 years to comply with the University’s Record Retention Policy.

If there is a request for subsequent data use from a closed research study, it requires IRB approval or an exemption from IRB review.

Commitments made such as the communication of research results or compensation to the subjects should be honored even if the study is terminated. These can be done for a terminated study with the permission of the IRB Chair or HSPPO Director.

When a principal investigator terminates employment or other association with the University, and there is not a qualified investigator to assume the role, then the current PI should close out the study.