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Office of the Vice President for Research Office for Human Subject Protection
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Study Closure

The completion or termination of a study is a change in activity and must be reported to the IRB.

At the time a study is complete or discontinued, the investigator must submit a Study Closure form with the following information included:

  1. Total number of subjects
  2. Problems/complications and subject withdrawal, as applicable
  3. Study results, if available

Study closure criteria

  1. The study is permanently closed to enrollment of new participants;
  2. You are no longer continuing to or planning to perform (for example, tests, physical or psychological exams, administer medications or treatments, etc.) on participants in order to gather data about them (including collection of data for follow-up);
  3. You are no longer continuing to or planning to interact (for example, letters, phone calls, interviews, re-contacting, etc.) with any participants in order to gather data about them;
  4. You are no longer continuing to or planning to gather any private identifiable information about participants.
  5. Data analysis is complete OR if you are continuing or planning to analyze data, the data does not contain participant identifiers or a link/code to identify study participants;
  6. If applicable, your sponsor/monitor has conducted the official close-out visit and will no longer require access to participant records or contact with the participants;

If applicable, documentation from the sponsor that all correspondence and queries related to the study have been addressed and the investigator’s participation in the study is complete.

NOTE: If the study does not expire (e.g., the study is Exempt, or the IRB has determined that Continuing Review is not required), a CR submission is not required to renew the IRB approval. A study closure should still be submitted when the study meets the study closure criteria noted above.

How to submit a study closure

  1. A study closure uses the Continuing Review (CR) application in the Click IRB system.
  2. Create a new CR application.
  3. As you check the boxes for the research milestones, a study closure question will appear if you meet the criteria for study closure.
  4. The application will ask you to acknowledge that the study will be closed. To close the study, you must select the acknowledgment check box.
  5. Complete the application and Submit the application.

Administrative study closure

If the Principal Investigator has not completed study enrollment and/or procedures and the study expires, they must immediately cease enrollment and all other activities related to the study. If a continuing review application has not been submitted before the study expires, the study will be administratively closed by IRB staff. In order to continue with the study, a new study application must be submitted to the IRB. The investigator may not continue until they have received IRB approval to do so.