For Irb Use Only

MONTCLAIR STATE UNIVERSITY

INSTITUTIONAL REVIEW BOARD

PROJECT COMPLETION FORM

Today’s Date

IRB Protocol # Expiration Date:

Project Title:

Principal Investigator’s Name:

Mr. Ms. Dr. Other

Department: College/School:

On Campus Phone: On Campus Fax:

E-mail:

For Student and Non-MSU PI’s:

Off Campus Address:

Off Campus Phone: Off Campus Fax:

Co-PI’s Name(s) (if any):

Mr. Ms. Dr. Other

Co-PI Department: College/School:

On Campus Phone: On Campus Fax:

For Student and Non-MSU Co-PI’s:

Off Campus Address:

Off Campus Phone: Off Campus Fax:

Status: (Check one.)

Faculty Doctoral student Masters student Undergraduate student

MSU Staff Other (Please explain.)

For student researchers only, please provide the following information:

Faculty sponsor: Department:

Sponsor’s phone: Sponsor’s fax:

Sponsor’s email:

Upon completion of a project, including data analysis, this form must be submitted. The IRB records will note that the project is closed. The PI will not receive acknowledgement or correspondence that the file is closed, unless it is found during the Completion review process that the protocol needs further review. If a project will not be completed by the Continuing Review expiration date, the Continuing Review guidelines above will apply. If all research activities will not be completed by the expiration date, please submit a Request for Continuing Review.

If a Project Completion Form or Continuing Review Form is not received by the expiration date, your project will become inactive and all research activity, including data analysis, must cease.Federal regulations and university policy prohibit continuation of research activity on inactive protocols. That means that enrollment of new participantsand all research intervention or interactionwith already enrolled participants, including data analysis, must cease unless the IRB determines that it is in the best interest of individual participants to continue.If your protocol becomes inactive, submission of a new Application for IRB Review will be required.

Incomplete responses will delay review and approval of your project.

If you have any questions, please contact the MSU IRB at (973) 655-7583.

A. Current Status of the Research

Please check here if all research activities, including data analysis*, are completed.**

*Data analysis is for this project only. If you plan for future analysis of data collected from this study, check the IRB guidelines to see if new IRB review is required. For future analysis, only the data from the participants who gave their consent for their data to be used in future projects may be included.

** If research activities, including data analysis, have not been completed, a Request for Continuing Review must be submitted to the IRB. Please refer to the IRB website forthe Request for Continuing Review and MSU IRB Continuing Review Policy.

B. Research Participants

(a) How many participants have participated in your study up to this point?

(b) How many participants have withdrawn from your study up to this point?

C. Relevant New Research Findings

Federal policy requires that you provide the following information regarding any new research findings (yours or others’) that could affect the risk to participants and/or their willingness to participate in your study.

Has any new information or research findings (yours or others’) become available that should be

disclosed to people who have participated in the study?

YES NO

If yes, summarize the new information or findings on a separate sheet.

D.Unexpected and Adverse Events, Complaints, Risks, & Benefits

1.Have any participants experienced reportable unexpected reactions and/or adverse events or complications since last scheduled review?

YES NO

If yes, was an Adverse Event Form submitted to the IRB?

YES NO

If no, please explain why. Please complete and submit an Adverse Event Form ASAP.

2.Have any participants complained about any aspects of their participation in the research?

YES NO

If yes, was an Adverse Event Form submitted to the IRB?

YES NO

If no, please explain why. Please complete and submit an Adverse Event Form ASAP.

E.Funding Information

1.Has this project received funding? YES NO

2.Are you currently seeking funding? YES NO

3. If no to both of the above, skip to the Investigator’s Agreement section. If yes, to either of the above, answer questions 4-9 below.

If yes, does the MSU Office of Research and Sponsored Programs have a copy of the complete grant/funding endorsement form?

YES NO (If no, attach a copy of the funding endorsement.)

5.Funding agency:

6.Contract or grant number:

7.PI of project:

8.Title of project:

9.Duration of grant:

Montclair State University Project Completion Form 1

Revised07/2011

For all applicants:

principal investigator’s agreement
As Principle Investigator, I understand that I have the fundamental responsibility to have conducted this study in accordance with ALL Montclair State University’s IRB policies and federal, state, and local laws that relate to research involving human participants.
I agree:

That submitted information in this application is accurate and complete
That this study was conducted in accordance with ALL Montclair State University’s IRB policies, guidelines, and approvals and federal, state, and local laws that relate to research involving human participants
To promptly supply the IRB with requested information
That when applicable, protocol information approved by MSU’s IRB for this study was consistently represented in ALL funding applications and processes
That, if there were any emergencies, only necessary study changes were made to ensure the participants’ well being without getting prior IRB approval
That any problems (e.g., complaints, injuries, adverse events)involving risks to participants and any necessary study changes made to ensure the participants’ well being without getting prior IRB approval were immediately reported to the IRB, sponsors, Data Safety and Monitoring Boards, and other agencies
That the Human Participants Protection Tutorial requirement was maintained, in accordance with the MSU IRB guidelines
To ensure that all research staff, who had contact with human participants and/or their data, maintained the Human Participants Protection Tutorial requirement, in accordance with the MSU IRB guidelines
That all research staff were qualified to conduct the research
That if research continued in my absence (during vacations, sabbaticals, etc.), I arranged for another PI to carry out my responsibilities
That if the Project Completion form was not returned by the expiration date AND a Continuing Review approvalhas not been granted, the study became inactive, and I ensured that ALL research activities ceased on the study’s expiration date

For Electronic Submission:
Typing your name on the line below serves as official signature to initially begin the IRB project completion process. By typing your name, you are consenting to the above agreement. Before project closure is granted by the IRB, you are required to submit a copy of this page with your physical signature either by fax, mail, or as an email attachment.
PI Signature Name ______Date ______
For Paper Submission of this page only:
Please print and sign this page in blue or black ink.
PI Name (please print or type) ______
PI Signature ______Date ______
For student PIs applications only:
faculty sponsor’s agreement
I agree:

That submitted information in this application is accurate and complete
That the student PI conducted this study in accordance with ALL Montclair State University’s IRB policies, guidelines, and approvals and federal, state, and local laws that relate to research involving human participants
That I (the Faculty Sponsor) met regularly with the student PI to monitor the study
To ensure that the student PI promptly supplies the IRB with requested information
That when applicable, protocol information approved by MSU’s IRB for this study was consistently represented in ALL funding applications and processes
That, if there were any emergencies, the student PI made only necessary study changes that ensured the participants’ well being without getting prior IRB approval
That any problems (e.g., complaints, injuries, adverse events) involving risks to participants and any necessary study changes made to ensure the participants’ well being without getting prior IRB approval were immediately reported to the IRB, sponsors, Data Safety and Monitoring Boards, and other agencies by the student PI
That the student PI maintained the Human Participants Protection Tutorial required by the IRB in accordance with MSU IRB guidelines
That all the student PI’s research staff, who had contact with human participants and/or their data, maintained the Human Participants Protection Tutorial requirement in accordance with the MSU IRB guidelines
That all the student PI’s research staff were qualified to conduct the research
That if research continued in the student PI’s absence (during vacations, sabbaticals, etc.), the student PI arranged for another PI to carry out his/her responsibilities
That if I (the Faculty Sponsor) was not available to advise the student PI’s research (during vacations, sabbaticals, etc.), I arranged for another Faculty Sponsor to carry out my responsibilities
That if the Project Completion form was not returned by the expiration date AND a Continuing Review approval has not been granted andthe study became inactive, I ensured that ALL of the student PI’s research activities ceased on the study’s expiration date

To expedite processing, it is suggested that the student PI forward this document to his/her advisor electronically. The Faculty Sponsor MUST print out this page, sign in blue or black ink, and forward to the IRB Administrator. A typed name in the Faculty Sponsor Signature line WILL NOT be accepted.
Faculty Sponsor Name (please print or type) ______
The faculty sponsor’s signature indicates that s/he has reviewed this application and accepts the responsibility of ensuring that the procedures approved by the IRB were followed.
Faculty Sponsor Signature______Date ______
For applicants seeking or funded by external sourcesonly:
Name of Funding Source ______
I certify that the research plan and safeguards to human participants described in this application conform to the plan and safeguards that have been submitted/will be submitted to an external funding source.
If a proposal has been submitted to an external agency through the Office of Research and Sponsored Programs, please attach a copy of the routing sheet. If funding has already been obtained, please attach a copy of the award letter.
For Electronic Submission:
Typing your name on the line below serves as official signature to initially begin the IRB review process. By typing your name, you are consenting to the above agreement. Before approval is granted by the IRB, you are required to submit a copy of this page with your physical signature either by fax, mail, or as an email attachment.
PI Signature Name ______Date ______
For Paper Submission of this page only:
You may also choose to print out and sign this page in blue or black ink.
PI Name (please print or type) ______
PI Signature ______Date ______
For student applications only:
To expedite processing, it is suggested that the student PI forward this document to his/her advisor electronically. The Faculty Sponsor MUST print out this page, sign in blue or black ink, and forward to the IRB Administrator. A typed name in the Faculty Sponsor Signature line WILL NOT be accepted. An approval letter will not be issued until an original signed agreement is received.
Faculty Sponsor Signature ______Date ______

Submission Instructions

Submission

Electronic submission of the Project Completion Form is required. Submit your form electronically by sendingit to the IRB at:

Please submit all pages that require original signatures
to the IRB office in hard copy format.

Electronic Submission Confirmation

To receive confirmation that the IRB received your submissions, activate the “RETURN RECEIPT” option in your email menu before sending your submissions.

Hard Copies of P.I. Agreement, Faculty Sponsor Agreement, and Funding page (if applicable) can be sent to:

Institutional Review Board

Montclair State University

College Hall Room 248

Montclair, NJ 07043

Phone: 973-655-7583

Fax: 973-655-3022

email:

FOR IRB USE ONLY

DO NOT WRITE BELOW THIS LINE

The signature of the IRB Chair confirms that all relevant information has been received and reviewed by the IRB, and this project is completed.

IRB Chair Signature Date

Montclair State University Project Completion Form 1

Revised07/2011