HRPP policies & procedures manual

404: Study completion

1. Purpose

The purpose of this policy is to describe how to close a research protocol or project.

2. Policy

The completion or termination of an expedited or full-board study is a change in activity and must be reported to the IRB.  Although subjects will no longer be “at risk” under the study, a final report to the IRB allows it to close the file.

3. Specific policies

3.1 Determining when a project can be closed

  • Subject enrollment is complete. All data collection is complete and the only remaining activity is analysis of the data.  The data are de-identified; there is no identifying link or code to the de-identified data and there are no active financial transactions to be completed (if funded).
  • Multi-site industry studies may be closed when the investigator submits a final report.
  • Exempt studies may be closed when there is no longer any contact with the subjects or data collection is complete.

3.2 Administrative closure of an exempt project

The IRB may close an exempt project if several documented attempts have been made to contact the investigator or student investigator and there has been no response.  Project closure notification will be sent to the investigator or advisor of the student investigator.

4. Applicable regulations and guidelines

21 CFR 56.108, 56.109

45 CFR 46.103, 46.109

5. Forms

Closeout report

6. Procedures employed to implement this policy & assignment of responsibility

IRB coordinator Instruct investigators to submit a closeout report form.

Review the project closure report and obtain any outstanding information or documentation from the investigator to close the study. If there are inconsistencies or if clarification is needed, request additional information.