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Study Closure

Overview

It is important that the IRB be kept informed about all phases of a research study including the point at which a study has been completed. Continued IRB approval is not required when the remaining study activities are limited to analysis of de-identified data and/or manuscript preparation.

Exempt, Expedited, and Full Board studies should be closed in PittPRO when the following 4 milestones have been reached:

  • The study is permanently closed to enrollment
  • All participants have completed all study-related interventions
  • Collection of private identifiable information is complete
  • Analysis of private identifiable information is complete

Studies that never started after IRB approval was issued should also be closed if there is no plan to pursue them further.

Studies that received a not human research determination through PittPRO should be closed when data collection or the receipt of data is complete. Studies determined to not involve research will be closed by the IRB once that determination has been made.

Note that once a study is closed in PittPRO, it cannot be reactivated so be certain that you meet all of the criteria.

As a reminder, when the PI identified in PittPRO leaves the University, the study must either be closed or a modification submitted in order to name a new PI. The same is true for studies that list a student as the PI. If the student does not submit a closure or a modification prior to graduating, it is the responsibility of the faculty mentor to do so.

The IRB reserves the right to close protocols that have been in the pre-submission or “clarifications required” state for longer than 3 months.  Prior to doing so, the IRB will inquire with the PI and named study staff to determine the status of the protocol.  If the PI or study team does not respond to the inquiries in the designated time frame, the IRB will close the protocol.  A new protocol would need to be submitted if study activities were to continue.

Submitting a Study Closure

Please note that the following steps are not applicable to studies that rely on an external IRB (ceded studies). For instructions on closing a ceded study, see the guidance entitled Pitt Cede IRB Review under the A-Z guidance on the website.

To submit a study closure, follow these steps:

  1. Log into PittPRO using your University or UPMC credentials.
  2. Identify the study by clicking on the “Active Study” tab and clicking on the study name.
  3. On the left hand side under “Next Steps,” click on “Create Modification/CR.”
  4. Select “Continuing Review” under “What is the purpose of the submission?”
  5. Provide a response to the question about enrollment totals.
  6. Under Research Milestones, check the first four boxes and then acknowledge that the study will be closed.
  7. Provide a response to the remaining questions and upload necessary documents.
  8. Click “Continue” and then “Finish”
  9. On the left hand side under “Next Steps,” submit the application. Note that only the PI has the ability to submit. If the PI is no longer at the institution, contact askirb@pitt.edu and request that a PI proxy be designated.

Lapsed Approvals

Allowing the IRB approval to lapse does not constitute an appropriate study closure and may be considered non-compliance because of the IRB’s inability to determine whether research activities continued after the lapse date.

Studies Released from Continuing Review

Even though a study qualified to be released from continuing review, it is still the responsibility of the PI to close the study when the criteria noted above are met.

Record Retention

Per University of Pittsburgh policy all research records must be maintained for at least 7 years following final reporting or publication of a project but may be kept indefinitely.

For projects involving children, records must be maintained until child participants reach the age of 25 if one of the following applies: 1) the research activities will result in the generation of a medical record OR the results of research will be put into an existing medical record; 2) the research activities involve procedures such as collection of blood, MRI, etc.; or 3) the research activities include measures (such as the SCID) which are generally used for clinical care but are being done for research purposes. All other records for studies involving minors can be retained for the standard 7-year period as required by University policy.

Retention requirements do not apply to identifiable information. See the following for reference:

4/18/2025