Institutional Review Board (IRB)

Office for Pre-Award and Compliance Services - MSC 100B

Ph: 518-437-3850 Fax: 518-437-3855 Email:

(Rev. 06/05/17)

Date Received / RCA Assigned
Submission # / Date of Determination

Protocol Closure Request

I am submitting this closure request as the Principal Investigator.

I am submitting a closure request, but I am not the Principal Investigator.

Name: Campus Email: Campus Phone:

Administrative closure (PACS Use only).

I. Protocol Information:

Principal Investigator:

Campus Address: Campus Email: Campus Phone:

Protocol Number: Protocol Expiration Date:

Protocol Title:

II. Reason for protocol closure:

Study is complete. I confirm that ALL of the following conditions apply:

Subject recruitment, enrollment and data collection are complete and no further contact with subjects is necessary.

Analysis of identifiable subject data is complete.

(Only if study was externally sponsored): The sponsored project has ended.

Name of Sponsor: Date award termed:

Award Title:

Study was cancelled. No subject enrollment or data collection took place.

Other (provide reason):

III. Final Report to the IRB

Research subjects (provide totals for entire study period):

Number of participants enrolled:

Number of participants who withdrew or discontinued participation:

Number of participants who completed the study:

Number of participants who became incarcerated during the study period:

Summarize any adverse events and/or unanticipated problems that have occurred since the last report. Criteria for reporting adverse events can be found at our website: Adverse Event Report Form

Summarize any reasons for participant withdrawal and any complaints about the research since the last IRB review.

Briefly summarize the research findings:

Disposition of subject data

If identifiable subject data is retained, please describe the storage, security and/or disposal plan and associated timeline for that data. If no identifiable subject data is being retained by the investigators, please state that.

Additional comments:

IV. Assurances and Signatures

Principal Investigator Assurance:

By signing below, I affirm that all information contained herein is true and accurate.

Principal Investigator Name (print) / Principal Investigator Signature / Date

Student Advisor Assurance:

By signing below, I affirm that all information contained herein is true and accurate.

Student Advisor Name (print) / Student Advisor Signature / Date

Administrator Review (PACS Use Only)

Closure of this protocol based on the following:

Closure requested by Principal Investigator.

Closure requested on Principal Investigator’s behalf by another University approver.

Administrative closure: PI did not respond to approval expiration notifications or closure was initiated for other institutional reasons (explain below).

Administrator Name (print) / Administrator Signature / Date

Administrator Comments: ______

______

______

______

1