Study Closure

Closing an IRB protocol

Study closure is required within a reasonable time frame of completion of full board and expedited research.

Study closure should occur when:

  • the study was not and will not be initiated;
  • the study was discontinued prior to its completion;
  • or the study has been completed.

Note that study closure is different from a renewal for a study that is closed to enrollment but for which data analysis continues. A study should be closed when all access to and use of identifiable data is complete.

Study closures are submitted to the IRB via Kuali Protocols.  Instructions for Requesting to Close a study can be found in the Kuali Protocols institutional guides.

You will receive a formal email from Kuali Protocols when the IRB Protocol has been closed.  You should keep a copy of this notification in your research records.

Post Study Closure

Once a study is closed, research personnel may continue to perform data analysis, manuscript preparation, and publication activities, so long as identifiable information is not being accessed.

All records produced or collected in connection with a research project must be retained for a minimum of three years after study closure, or longer if subject to federal regulation (including HIPAA) or sponsor requirements.  Always review the IU HRPP Policy on Research Data Management before destroying or deleting research records.

If a study that is Closed needs to be re-opened for any reason, a new study submission will be required.  Kuali Protocols does not allow a Renewal to be created on a Closed study as a means of re-opening the study.



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