Investigators are required to submit final closeout reports when all of the following apply:

• Study is permanently closed to enrollment
• Participants have completed all research activities
• Collection and analysis of identifiable information is complete

For non-exempt studies excused from continuing review, as they approach five years from the date of approval, reminders from ARROW will be sent to the study team informing them that if they are still doing research on the project, they need to go to main application workspace in ARROW and renew the approval via the “Renew Approval” activity. If research is no longer being done on the project, then a closure report should be submitted (see below).

A final report (i.e., closure report) is required within 30 days of study close out or approval of a replacement application for all non-exempt research, including for studies that are not subject to continuing review. Studies can be closed when all study activities are completed; data analysis may continue only if all data is de-identified. If UW-Madison is a participating site in a multisite study, the UW-Madison may be closed with the permission of the coordinating center even if the overarching study remains open.

The IRB may require closure and re-submission of any study under the following circumstances: no research activities have begun, or no participants have been enrolled within 3 calendar years from the date of the IRB approval of an initial review application; the IRB application and/or protocol needs to be updated to meet current IRB and regulatory standards; or a study or protocol appears to have changed substantially from the IRB’s original assessment of it.

For research where an exemption is granted, a 3-year expiration deadline is assigned in ARROW. Once the 3 years have lapsed, the protocol will automatically be closed in ARROW. If the study team has not yet concluded the protocol, a request to Extend Exemption can be submitted prior to the 3-year deadline. Reminders of an upcoming exemption expiration will be sent at 90, 60 and 30 days prior to the set expiration date.

Resources

We recommend reviewing the following resource documents:

• How to Close Studies
  Step-by-step instructions for submitting a study closure report.
• Investigator Manual (HRP-103)
  Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Wisconsin-Madison.