To Be Completed by the Investigator

External IRB Study Closure Version 2.0

To Be Completed By the Investigator
Date Application Completed: / UIC Protocol #:
Application Document Version #: / OPRS Use Only - Assigned IRB:

I. Name of Research Network:

II. Name of External IRB:

III. Protocol Title:

IV. Principal Investigator (PI)

Name (Last, First) / Degree(s) / Net ID
Department / College / University Status/Title
Mailing Address / M/C
Phone Number / Fax Number / E-mail Address

V. Reason for Study Closure

Check all that apply:

Research was initiated, but no subjects were ever enrolled.

(Skip to the last page – Assurance Page)

Research at other study sites have closed the study (only applicable for multi-center studies where UIC is the lead or coordinating site).

(Include documentation of study closure at other sites and select other applicable boxes.)

The following items regarding the research at UIC have been met:

·  enrollment has been completed,

·  there will be no further contacts or interactions with the subjects (including long term follow-up),

·  data collection is complete,

·  the only remaining activity is analysis of de-identified (no identifying links or codes) data (including video/audio files), and

·  there is no additional research beyond the original intent planned for these data.

For Sponsored projects, please include the Sponsor’s “close-out” letter when applicable.

The following items regarding the research at UIC have been met:

·  enrollment has been completed,

·  there will be no further contacts or interactions with the subjects (including long term follow-up),

·  data collection is complete,

·  analysis of identifiable or coded data is complete, and

·  there is no additional research beyond the original intent planned for these data.

For Sponsored projects, please include the Sponsor’s “close-out” letter when applicable.

The following items regarding the research at UIC have been met:

·  enrollment has been completed,

·  there will be no further contacts or interactions with the subjects (including long term follow-up), and

·  the investigator is following the sponsor’s guidance regarding the ability to close the study with the IRB while continuing to address data queries.

For Sponsored projects, please include the Sponsor’s “close-out” letter when applicable.

The PI is terminating the research.

Specify the reason(s) why research was stopped before meeting approved goals/objectives:

The PI is leaving/has left the institution and the Faculty Sponsor/Department Head is terminating the research.

The Sponsor is terminating the research.

Specify the reason(s) for termination (e.g. interim analysis revealed substantive findings):

VI. Final Reports

A. Provide a copy of the study closure notice from the external IRB and a copy of the final or most recent annual report.

No Yes If YES, list and attach copies of each.

If No, provide an explanation.

VII. Assurances

INVESTIGATOR’S ASSURANCE FOR FINAL REPORT OF RESEARCH

I certify that the information provided in this Final Report is complete and correct. I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and welfare of human subjects, and the ethical conduct of this research. I confirm that I have complied with applicable UIC policies and procedures, as well as with applicable federal, state and local laws. I also agree to the following:

·  The research was performed by qualified personnel as specified in the approved research application and/or protocol.

·  No changes were made to the research protocol (except when necessary to eliminate apparent immediate hazards to the subject), or the consent process (if one was required) without prior approval by the IRB of record.

·  Legally effective informed consent/assent was obtained from all human subjects, unless the UIC IRB waived this requirement.

·  Unanticipated problems involving risks to subjects or others (including adverse events) and subject complaints were reported to the IRB of record and the UIC OPRS in a timely manner.

______

Principal Investigator Date

Name printed:______

DEPARTMENT HEAD* SIGNATURE

*If the Department Head is the Principal Investigator or any of the Co-Investigators, the Department Head’s superior (for example: Dean), must sign in place of the Department Head.

As department head (or signatory official), I acknowledge that this research was conducted by the standards set by our department and I insure that the Principal Investigator met all departmental requirements for review and approval of this research. By my signature as department head (or signatory official) on this research application, I certify that the Principal Investigator had the training and expertise to conduct research at UIC and that the research met the standards of the specific discipline, as well as the standards and guidelines of any relevant professional organizations, societies, or licensing bodies.

Department Head Signature: ______Date______

Name printed: ______

Page 2 of 3 OVCR Document #0973