Instructions: Complete this form when an approved human subjects research project is completed or ends for any reason. Once a Project Closure Form is submitted, no more data may be collected about any of the subjects/participants in the study. Projects that involve long-term follow-up (either directly from subjects or indirectly from existing records) must remain open, even if enrollment of new participants has ended. Please send the completed and signed Project Closure Form as hard copy to the IRB Office and a soft copy by email to irb@aub.edu.lb
Whenever possible, please include a final summary of the project with this form.
Principal Investigator:
Department:
Project Title:
Phone:
Number of Subjects Enrolled:
Human Subjects work has ended on this project for the following reason(s):
_____Project completed
_____Project not funded
_____PI no longer at AUB (and project has not been transferred to a new PI)
Location of signed Informed Consent Documents, if applicable__________
_____Project canceled for other reason.
Please describe:
Reminder : The PI is required by AUB and federal regulations to maintain records of all correspondence relating to the use of human subjects in research. Copies of the IRB application forms, amendments, notices of approval and signed Informed Consent documents must be maintained in the investigator’s records. Copies of these research records must be kept for three (30 years after the close of the study, irrespective of the reason for closing the study. Studies that involve drugs or devised seeking FDA approval must be kept for two (2) years after the FDA has taken final action on the marketing application. All records of human subjects research are subject to inspection by federal authorities and the IRB.
________________________________
Signature of Principal Investigator
____________________
Date
SBS Project Closure Report
Version #1
September 27 2010
Page 1 of 1