Protocol Closure Report of Previously Approved Research
For Biomedical Research Projects
American University of Beirut
AUB Biomedical IRB
IRB Protocol #
Instructions: Please note that a protocol previously approved by the AUB Biomedical Institutional
Review Board (IRB) should be closed if the protocol has been completed (including subject participation,
subject follow-up, long-term observation, and data analysis) or if the study is terminated. Please complete
the following information and submit one original signed hard copy to the IRB Office and a soft copy by
email to irb@aub.edu.lb
Principal Investigator Name:
Protocol Title:
PI Office Address:
Phone:
E-mail:
Fax:
Point of Contact Name:
Office Address:
Phone:
E-mail:
Fax:
1.
Reason for Protocol Closure/Termination
Protocol and data analysis complete for the entire study
Protocol and data analysis complete for all sites under AUB purview (i.e., sites at which AUB
faculty, staff, students, or agents are responsible for the oversight of research activities)
Protocol is complete, data analysis will continue but data have been de-identified (no links to
identifiers kept)
Protocol terminated
If terminated, please specify reason for termination:
Lack of funding or funding not renewed
Other, please explain:
2.
Date protocol was closed:
Biomedical Protocol Closure Report of Previously Approved Research
Version #1
September 27 2010
Page 1 of 3
Final enrollment or data/sample collection information for sites under AUB purview
3a. For studies only involving specimen collection or review of medical records or
datasets, indicate:
i. Number of samples or charts the IRB approved for collection/review
ii. Number of samples obtained or charts reviewed
3b. For studies involving enrollment of subjects indicate:
i. Total number of subjects the IRB approved for enrollment
ii. Total number of subjects who signed a consent form (indicate “not
applicable” if written documentation of consent was not required)
ii. Total number of subjects who completed study participation and were not
withdrawn/did not withdraw participation
iii. Total number of subjects withdrawn by the researcher
iv. Total number of subjects who withdrew their participation
3.
4.
Serious Adverse Events
a. Did any adverse events occur since the last continuing review or the initial review of the protocol
that were serious, unexpected, and probably related to study participation?
Yes
No
b. If yes to question a, did any of the events meet the AUB IRBs’ Serious Adverse Event Reporting
Guidelines? [INSERT LINK TO Guidance for AUB PIs for Reporting of Unanticipated Problems
involving Risk to Subjects and Others]
Yes
No
c. If yes to question b, please describe (i) why the events were not previously reported and (ii)
indicate whether the events represent new information, such as late effects of a study drug, that
should be conveyed to study participants and attach copy(ies) of the Unanticipated Problems
Report form:
5.
Unanticipated Problems
Did any unanticipated problems involving risks to subjects or others occur since the last continuing
review of the protocol or the initial review (whichever was most recent)?
Yes
No
If yes, describe these events:
6.
Subject Complaints
Were any complaints received from subjects that could not be resolved by the research team since the
last continuing review of the protocol or the initial review (whichever was most recent)?
Yes
No
If yes, describe the nature of these complaints and what was done to attempt to resolve them:
7. Data Safety and Monitoring: .Was the research study subject to Data Safety Monitoring (DSMB) or
other similar committee/group review?
If yes, provide a copy of the final or most current report.
Biomedical Protocol Closure Report of Previously Approved Research
Version #1
September 27 2010
Page 2 of 3
If no, are you aware of external (non-AUB IRB oversight) Serious Adverse Events? Please describe.
__________________________________________
Signature of Principal Investigator
________________________
Date
Printed name of Principal Investigator
Biomedical Protocol Closure Report of Previously Approved Research
Version #1
September 27 2010
Page 3 of 3