Final Report / Study Closure

When all study related activities, including patient recruitment, treatment, follow-up and data analysis are complete, a Final Study Report/Study Closure Form must be submitted to the IRB in place of the Application for Continuing review.

The following must be included in the submission of an expedited Final Study Report/Study Closure:

1 original and 2 copies of the Final Study Report/Study Closure Form,

3 copies of the Principal Investigator’s final report or any article submitted, in press, or published. For student research, this can be the draft dissertation or final paper.

Final Study Reports/Closure submissions for expired protocols must include 1 original and 2 copies of the Request for Closure of an Expired Protocol form.

The following must be included in the submission of an full Final Study Report/Study Closure:

1 original and 20 copies of the Final Study Report/Study Closure Form,

21 copies of the Principal Investigator’s final report or any article submitted, in press, or published. For student research, this can be the draft dissertation or final paper.

Final Study Reports/Closure submissions for expired protocols must include 1 original and 21 copies of the Request for Closure of an Expired Protocol form.

Following review, the closure application will receive one of the following status determinations: Terminated, Approvable pending re-review by the chair or his/her designee, Approvable pending re-review by the subcommittee, or Approvable pending re-review by the full board.