Office for Research Protections
The 330 Building, Suite 205
University Park, PA 16802
814-865-1775
Fax: 814-863-8699
ORProtections@psu.edu
Project Close Out Form for Research Involving Human Participants
Form Instructions:
o To complete the form, press TAB or SHIFT TAB between boxes and enter an ‘X’ or text. For assistance, contact the Office for Research
Protections.
o Handwritten applications will NOT be accepted. Submit ONLY one completed and signed Project Close Out form.
IRB#: _____
Review Type: _____
Title: _____
Principal Investigator: _____
Telephone: _____
Mailing Address: _____
Email Address: _____
College: _____
Department: _____
Funding Agency: _____
SIGNATURES ON THE PROJECT CLOSE-OUT FORM:
Signatures are no longer required on the Project Close Out form. The Project Close Out form may be submitted as an email attachment to
ORProtections@psu.edu in one email. However, the form must be submitted by one of the following:
 Principal Investigator (PI);
 Co-Investigators;
 Project Coordinators; or
 Advisors
If the Project Close Out form is not submitted by the Principal Investigator, it is expected that (1) the PI has read and concurred with the information
in the Project Close Out form AND (2) the PI must be copied on the email. Please include the IRB number in the subject of the email.
1. Project Status
_____ I would like to close this research protocol.
2. Activity Status
_____ Enrollment closed, study completed
_____ Enrollment closed, participants have completed study procedures; data analysis ONLY
_____ Study never initiated, enrollment not started, closing study
A participant is considered enrolled if he/she has signed an informed consent form and is entered in the research.
PLEASE NOTE: If contact with participants is needed during data analysis, a new application must be submitted for review and approval through
PRAMS (http://www.prams.psu.edu).
3. Project Information
A. Provide a brief summary of your progress to date. If participants have not yet been enrolled, explain why. Use ordinary language
and avoid technical terms/jargon.
_____
4. Participant Information
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This form is available electronically at http://www.research.psu.edu/orp/areas/humans/applications/index.asp.
A. Number of participants enrolled in this study:
Males: _____
Females: _____ Total: _____
5. Other Events
Unanticipated/Adverse events: Unanticipated and/or adverse events involving risk to participants or others must be reported to the IRB according
to IRB Policy I, “Reporting of Unanticipated Problems Involving Risks to Participants or Others”. This policy may be located at
http://www.research.psu.edu/orp/areas/humans/policies/index.asp.
A. Have any mild or moderate adverse events that were expected or unexpected and related or possibly related occurred since your
last approval on this study?
_____ Yes  Attach the Non-Significant Tracking Log
_____ No
B. Have any grievances, complaints or positive reactions been received about this research since your last approval on this study?
_____ Yes  Explain: _____
_____ No
C. Have unexpected events, toxicities, or complications occurred that may indicate a need for a change in the research or consent
form since your last approval on this study?
_____ Yes  Explain: _____
_____ No
D. Have any participants withdrawn from the research since your last approval on this study?
_____ Yes
 How many?
_____
 What was the reason for the withdrawal?
_____
_____ No
IMPORTANT INFORMATION REGARDING RETENTION OF INFORMED CONSENT FORMS & RESEARCH RECORDS:
If this study was originally submitted after July 1, 2002, the principal investigator is expected to maintain the original signed consent forms as well as
the research records for at least three (3) years after the close of the study unless the study falls under the Health Insurance Portability and
Accountability Act (HIPAA). For studies that fall under HIPAA regulation, signed informed consent forms and research records must be kept for a
minimum of six (6) years. Further guidance on signed informed consent form retention and destruction may be located at
http://www.research.psu.edu/orp/areas/humans/samples/retention.asp.
If the research study falls within the purview of the Food & Drug Administration (FDA), the principal investigator is responsible for retaining the signed
documents and research records for the period specified in valid FDA regulations.
Page 2 of 2 – Version 1.2 – Created 2004; Revised 7/4/06; 5/12/10
This form is available electronically at http://www.research.psu.edu/orp/areas/humans/applications/index.asp.