Viterbo University - The University of Opportunity: Hope and Help
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Viterbo University Institutional Review Board
 

Study Closure Form 

Project Information

1. Principal Investigator:   

2. Email:
 
3. Title of project:


4. Reason for study closure.
    Explain the reason:
  Explain the reason:

    Date completed: 
 

Participants

5. Approximately how many participants were solicited for the study?   

6. How many participants were enrolled in the study?   

7. How many participants completed the study?   

8. If any participants withdrew from the study, describe the reason for their withdrawal.
 
 
If your study utilized existing data, answer only question #6 in reference to the approximate number of records or files that were accessed.
 

Protocol Deviations

9. Did you implement any deviations from the approved research protocol?
         (If no, skip to question #13.)

10. Describe the deviation(s).

 
11. Did you submit a protocol modification request to the IRB?
          

12. If you did not submit a protocol modification request to the IRB, explain the rationale.
 
 

Unanticipated Problems or Adverse Events

An unanticipated problem is defined by federal regulations as any incident, experience, or outcome that is (a) unexpected given the research procedures and the characteristics of the subject population being studied (b) related or possibly related to participation in the research and (c) suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.

An adverse event is defined by federal regulations as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.

13. Were there any unanticipated problem(s) or adverse event(s) involving risks to participants?  
   
       (If no, skip to question #17.)

14. Describe the problem(s) or event(s).


15.
Did you report the problem(s) or event(s) to the IRB?
     
    

16. If you did not report the problem(s) or event(s) to the IRB, explain the rationale.

 

Participant Complaints

17. To your knowledge, were there any participant complaints about the study?   
          

18. If there were participant complaints about the study, describe them.

 

Data Storage and Destruction

A study may not be closed until all personally identifiable data have been destroyed.  However, signed informed consent forms must be kept in a locked location for a minimum of three years following completion of the study.

19. If you collected identifiable information about participants, has the data containing these identifiers been destroyed?
        

20. If signed informed consent form were required, have they been destroyed? 
            (If yes or not applicable, skip questions #21 and #22.)

21. Where are signed informed consent forms currently stored?

 
22. When and how will signed informed consent forms be destroyed?

 

Researcher's Assurance

I hereby certify that the information provided in this form is accurate and complete.

Principal Investigator: 

Principal Investigator's ID Number (found on Viterbo University ID card): 

Date: