IRB Study Closure and Final Report - University of Western States

Section A: General Information

Project title:(Required)

Principal investigator (PI):(Required)

Email:(Required)

Phone(Required)

Co-principal investigator(s):

Co-investigator(s):

Key personnel:

Section B: Project Information

Date project closed:(Required)

Reason for closing project:(Required)

Completed

Discontinued

Research never started

Not funded

Other

If discontinued, never started, or other, please explain.(Required)

Total number of participants enrolled in this study:(Required)

Total number of participants who withdrew from the study:(Required)

Total number of participants data was collected from:(Required)

If no notification has been sent, please explain:(Required)

Section C: Adverse/Unanticipated Events

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

Yes

If yes, provide a summary of any unanticipated problems and/or adverse events that occurred:(Required)

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

Access the incident report form here.

N/A

Yes

Did you receive any complaints about the research?(Required)

Yes

If yes, describe the complaints and how they were handled.(Required)

Section D: Data Storage

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

Section E: Risks

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

Yes

If yes, please explain:(Required)

Section F: Research Progress

Please provide a brief summary of the study results. You may attach a copy of the final report submitted to your funding agency if available. For dissertation students, please include a summary of results from your dissertation defense.(Required)

File Upload:

Max. file size: 10 MB.

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 SignNow to confirm the details within the form.