Rev – 5/20/09 Study Closure Form
Tulane University Institutional Review Board
Study Closure Form
Please complete this study closure form when all subjects have finished all scheduled visits and the follow-up and the data analysis phases have been completed.
The Tulane University IRB will close the study upon receipt of this closure report and a letter will be sent to the Principal Investigator indicating the administrative closure of the study.
If you have any questions, please contact:
Tulane University Human Research Protection Office
IRB: Biomedical and Social/Behavioral
1440 Canal Street
Suite 1705
Tidewater Building TW-36
New Orleans, LA 70112
(504) 988-2665
http://tulane.edu/asvpr/irb/
Protocol Title:
Tulane University IRB #:
Date of Expiration:
Note: Closure of a study means that no further research, follow-up, or data analyses will be performed. If any subjects are still participating, the study may not be closed. Closure of the enrollment phase does not mean the closure of the study.
Section A: General Information
1. Principal Investigator:
Last Name: / First Name:Campus Address: / Mail Code:
City: / State: / Zip Code:
Phone: / Fax: / Email:
2. Co-Investigator/Study Coordinator:
Last Name: / First Name:Campus Address: / Mail Code:
City: / State: / Zip Code:
Phone: / Fax: / Email:
3. Reason for Closure:
Data collection has ceased and there is no ongoing follow-up or data analysis of subjects
The FDA, the OHRP, the IRB, the Sponsor, or any other regulatory agency has terminated the study.
You must attach all relevant documentation from the terminating party.
The study is being withdrawn – the study has not been initiated; no subjects have been enrolled; or the study will not be conducted at this site. Explain:
The study is being terminated due to insufficient subject enrollment. Explain:
4. Funding Status – Note: Submit the grant proposal or contract if not on file with the IRB
Project is currently funded: No Funding Obtained or Applied For. Funding Agency (e.g. NIH):
Grant/Contract Number:
Project has been submitted for funding: Industry-Sponsored
Funding Agency (e.g. NIH):
Section B: Subjects
5. For the purpose of this form, the term “subjects” should refer to all participants, patients, etc. Indicate the number of subjects enrolled at each of the following sites:
Tulane University Hospital and Clinic:
Tulane University Campuses:
International Site (List name of site and number enrolled):
Other (List name of site and number enrolled):
Other (List name of site and number enrolled):
Other (List name of site and number enrolled):
Other (List name of site and number enrolled):
Other (List name of site and number enrolled):
Other (List name of site and number enrolled):
6. Total number of subjects who were approved for enrollment for this research study:
Section C: Unanticipated Problems/Withdrawal from Study
7. Were there any Unanticipated Problems or other Serious Adverse Events (SAE) with the research, the site, or the subjects that have not been previously reported to the Tulane University IRB? If Yes, please attach the Unanticipated Problems form.
8. Did any subjects voluntarily withdraw from the study for medical or non-medical reasons? If Yes, provide a description of any known reasons for which a subject would withdraw.
Section D: Study Results
9. Summarize the final results of your study. Also attach copies of relevant publications.
Section E: Principal Investigator’s Statement of Assurance
I certify that the information provided in this application is complete and correct.
No further research, subject treatment, follow-up analysis, or data analysis associated with this study will continue past the date given below.
______
Signature of Principal Investigator Date
*Forms are subject to change. Check for the latest forms through IRBNet. 4 of 4