Human Subjects

Study Closure

Study closure is required for all FDA regulated and all greater than minimal risk studies, and the closure requires approval by an IRB member. Study closure must be reported to the IRB within a reasonable time frame. At a minimum, the closure must be reported prior to study expiration.

For minimal risk, non-FDA regulated studies, reporting of study closure is optional.

Study closure may 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 completed study is eligible for closure only if at least one of two conditions is met:

  • All data analysis involving the research site(s) under the Indiana University IRB approval is complete.
  • OR

  • All data has been de-identified, with no codes or keys that would allow for the potential to identify subjects in the future.

Study Closures are submitted to the IRB via the KC IRB “Request to Close” action on the KC IRB Protocol Action tab. The following information should be gathered PRIOR to beginning the Closeout Report questionnaire:

  • Total number of subjects who were consented, failed screening, or withdrawn (and the reasons for withdraw, if applicable) since last IRB review;
  • Total number of subjects who were enrolled , failed screening, or withdrawn since the beginning of the study;
  • Reasons for subject withdrawal;
  • Whether the study is conducted at, funded by, or recruited from the VA (and number of VA subjects, if applicable);
  • Information pertaining to the number of subjects enrolled from a vulnerable population, 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.

Important Note Regarding Attachments: It is important to note that when including any attachments with the closeout submission they must be attached last, just prior to completing the “submit” action, in order to ensure the attachments are properly included in the submission to the IRB. For specific instructions on how to submit a study closure, visit Request to Close an IRB Protocol.

Documentation of acceptance of study closure information is provided via the KC IRB Closure Notice. If you have questions regarding your specific study or situation, please contact the HSO.

A closed study may be reactivated within 6 months with submission of a renewal. To reactivate a study that has been expired or closed for more than 6 months, a new application must be submitted.

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