IRB Study Closure and Final Report

This form should be completed when all aspects of the research study have been concluded. This means data collection has ceased, participants are no longer being enrolled, no follows-ups with participants are planned, and activities (e.g. data analysis, manuscript preparation) that require use of personal identifiable information are complete).

Section A: General Information

Project Title:

Principal Investigator (PI):

Email:

Phone:

Co-Principal Investigator:

Co-Investigator(s):

Key Personnel:

Section B: General Information

Date project closed:

Reason for closing project:

Total number of participants enrolled in this study:

Total number of participants who withdrew from the study:

Total number of participants data was collected from:

If no participants were enrolled in this study, please explain why:

Section C: Adverse/Unanticipated Events

Were there any unanticipated problems or adverse events during the study?

If an unanticipated problem/adverse event occurred, was an incident report form submitted to the IRB?

Did you receive any complaints about the research?

Section D: Data Storage

Where are your project files being stored? Please indicate specific locations.

Section E: Risks

Since the last IRB review, has the level of risk to participants changed at all?

Section F: Research Progress

Please provide a brief summary of the study results.

Section G: Certification

I certify that the approved research protocol is complete and should be closed. I understand that closure of this research protocol means that no further data collection, follow-up with participants, coding of data, data analysis and manuscript preparation that requires personal identifiable information may be conducted. I agree to retain all research materials for at least three (3) years after closure of the research project and acknowledge that these documents may be subject to audit/review by the Institutional Review Board if deemed necessary.

Gather all Appropriate Signatures

Upon receipt and approval of the IRB Study Closure and Final Report Form, you and any other members of your study team will receive a request via Adobe Sign to confirm the details within the form.