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 is eligible for closure 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 Kuali Coeus IRB Request to Close an IRB Protocol action on the KC IRB Protocol Action tab. 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- Total number of subjects who were enrolled, failed screening, or withdrawn since the beginning of the study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 the study is conducted at, funded by, or 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
A closed study may be reactivated within six months with submission of a renewal. To reactivate a study that has been expired or closed for more than six months, a new application must be submitted.
Documentation of acceptance of study closure information is provided via the KC IRB Closure Notice.