Viterbo University Institutional Review Board
Study Renewal Form
1. Principal Investigator:
2. Email Address:
3. Title of Project:
4. Study Status:
, but research activities or participant follow-up continue.
5. Anticipated Project End Date:
6. Was the study originally scheduled to be completed within a year from the date of first approval?
7. If the study was originally scheduled to be completed within a year, explain why it was not completed on schedule.
8. Describe the research activities completed to date.
9. Describe the remaining research activities to be completed.
10. Since the last IRB review, has there been any new information from this study, the literature, or elsewhere that would suggest any aspect of your research protocol might involve higher levels of risk than previously anticipated?
11. Approximately how many participants have been solicited for the study to date?
12. How many participants have been enrolled in the study to date?
13. How many participants completed the study to date?
14. If any participants have withdrawn from the study, describe the reason for their withdrawal.
If your study utilizes existing data, answer only question #13 in reference to the approximate number of records or files that have been accessed.
15. Have you implemented any deviations from the approved research protocol?
(If no, skip to question #19.)
16. Describe the deviation(s).
17. Did you submit a protocol modification request to the IRB?
18. 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.
19. Have there been any unanticipated problem(s) or adverse event(s) involving risks to participants?
(If no, skip to question #23.)
20. Describe the problem(s) or event(s).
21. Did you report the problem(s) or event(s) to the IRB?
22. If you did not report the problem(s) or event(s) to the IRB, explain the rationale.
23. To your knowledge, have there been any participant complaints about the study?
(If no, skip question #24.)
24. Describe the complaint(s).
I hereby certify that the information provided in this form is accurate and complete.
Principal Investigator's ID Number (found on Viterbo University ID card)