Baptist Health Institutional Review Board. Study Closure Report (Expedited Review) IRB #: Study Title:

Transcription

1 Baptist Health Institutional Review Board Study Closure Report (Expedited Review) (Please complete ALL sections of this form. Incomplete forms will be returned) Principal Investigator: Phone #: Pager#: Research Coordinator: ((Name, phone #, ) IRB #: Study Title: Date of IRB Expiration: ALL QUESTIONS MUST BE ANSWERED. 1. We wish to close this study: All interventions are completed on all subjects and only statistical analysis of already collected data that is now de-identified or no links to identifiers remain. NOTE: You may close the study. If so, you must attach a letter signed by the PI certifying that the data as been de-identified. All interventions, data collection, and data analysis are completed.

2 2. During this review period, have there been ANY changes, no matter how minor, to any part of this research project, including the IRB approved forms? No. Yes. If yes, select one: All changes implemented to this project have been previously reported to and approved by the IRB. Changes have been implemented but were not submitted to the IRB. Explain: 3. Are you submitting any new revisions along with this Study Closure Report? No. Yes. You must include: An amendment form, all altered pages, both a tracked and untracked copy, and a summary of the changes. 4. Study Sponsor: Is your study sponsored? No. Skip to question 5. Yes. Provide the name of all the study sponsors: 5. Have there been any changes in the potential conflict of interest described in the initial submission for any of the investigators (including Principal Investigator, Co- Investigator, Sub-Investigator, etc.) associated with this project? Describe: Please submit a new Financial Conflict of Interest form for each Investigator participating in this study. Any studies submitted without the Financial Conflict of Interest forms will be returned. 6. External audit: Has the Food and Drug Administration (FDA), study sponsor or other agency audited this project during this review period? If yes, have these reports been submitted? Yes No If no, indicate who conducted the audit and when you expect to submit the reports to the IRB:

3 7. Have any subjects enrolled in this project? No. Explain why you have not started this project: Yes. # of subjects who have signed an informed consent document. # of subjects enrolled since previous IRB review. # of subjects consented that did not participate since previous IRB review (include an explanation for each). Have you enrolled more subjects than currently listed in the project s last approved protocol? Explain: 8. Provide a description of study activities to date, including any difficulties in recruiting subjects: 9. Was an Informed Consent Form (ICF) signed by each subject or their legally authorized representative? Yes No Explain: Did all subjects or their legally authorized representative receive a copy of the ICF? Yes No Explain: 10. Describe any subject complaints, concerns, or comments about the study: 11. Have all protocol deviations been reported to the IRB? Yes No Please attach a log of all protocol deviations that have occurred since the last IRB approval. 12. Does this study have an oversight committee or Data Safety Monitoring Board (DSMB)? If yes, what was the date of the last report:. Please submit this report with this form. A report is not available. Date report will be available:

4 13. Is there any other new information (from the research itself or other sources) that alters the risk/benefit ratio of this study? Explain: 14. Risk/Benefit ratio evaluation: Did the Risk/Benefit ratio of this study change for any reason during this review period? Explain: 15. Since the Previous IRB review approval, have any unanticipated problems involving risks to participants and/or serious unanticipated research related adverse events occurred at sites where a BMC/WCH investigator is involved in the conduct of the research or is responsible for regulatory reporting? If yes, Total number of events/problems previously reported to the IRC? Are there any events that have not been reported to the IRB? Explain: 16. Is this a multi-center study? If yes, since the last IRB review approval, have any unanticipated problems involving risk to participants and/or serious or unanticipated and research related events occurred at sites where a BMC/WCH investigator is not involved in the conduct of the research or is not responsible for regulatory reporting (off-site adverse events)? Total number of off-site adverse events previously reported to the IRB. Total number of off-site adverse events not previously reported to the IRB. Please explain why these were not reported.

5 Print a copy of this form and: Type AND sign your name below. Submit an electronic copy to ircsubmission@bmcjax.com along with a scanned copy of the signature page with original signature. Submit revised Financial Conflict of Interest form. Make a copy of the signed report for your regulatory file. In addition to the above responses, I confirm that a current IRB-approved consent form has been signed, dated, and is retained in my files for every participant enrolled in this study and a copy was provided to the person who signed this form (if use of a consent form was required). I also confirm that no changes to study procedures or the consent form(s) were initiated without prior IRB approval. Person completing Study Closure Form: Signature: Date: Principal Investigator: Signature: Date: NOTE: This form must be signed by the PI unless you have previously notified the IRB of a Transfer of PI responsibility.