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 KC IRB.  For instructions on how to request to close an IRB Protocol, go to: Quick Guide: Request to Close an IRB Protocol. You should gather the following information before beginning the Closeout Report questionnaire:

  • Total number of subjects who were enrolled, failed screening, or withdrawn since the beginning of the study
  • Reasons for subject withdrawal
  • Whether subjects were recruited from the VA (and number of VA subjects, if applicable)
  • Information pertaining to any reportable events (either requiring prompt report or not requiring prompt report) since last IRB review
  • Information pertaining to the data safety monitoring plan and available data safety monitoring reports, if applicable
  • General information about study results, including trends and observations; whether subjects received benefits from participation; and whether there was any indication of a change in the risk to benefit assessment.
  • Significant findings from external sources, including literature reviews or external (non-IU) audits.

Documentation of acceptance of study closure information is provided via the KC IRB Closure Notice.

Please note: to Close an Exempt Protocol, access your Protocol in KC IRB, go to the Protocol Actions tab, and take the Close action.

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. Closed study records containing identifiable information should only be accessed by the study team when requested by the IRB or a regulatory agency.

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 confirm with the IU HRPP Policy on Research Data Management before destroying or deleting research records.

Research personnel may request the IRB reopen a research study that was prematurely closed. This is usually done using the renewal action in KC IRB; however, depending on the nature of the study and the length of closure, the IRB or HRPP may require that a new study application be submitted.

Questions?

  • Phone: 317-274-8289
  • Email: irb@iu.edu