Human PET Research Approval Form Human PET Research Application University of Pennsylvania, Department of Radiology *Please be aware that ANNUAL renewal of this form is necessary* 1) Date: New application: Renewal: 2) Project Title: 3) Penn IRB Protocol Number: Expiration Date: 4) Principal Investigator: Institution/Company (if not Penn): 5) Penn ID#: 6) Institution/Company (if not Penn): 7) Phone: 8) E-Mail address: 9) Primary User(s) (if different from PI): Name Campus Phone E-Mail Penn ID# By completing this form each investigator is confirming that they have obtained all required regulatory and human use approvals from the University of Pennsylvania. PI Signature: Date: 10) If this project is not funded and you are requesting time for protocol development (PRODEV), give a brief explanation of how you plan to pursue funding in the future: 1 Version 6 -Revised 2/12/16 Human PET Research Approval Form 11) If funding is already available for the requested instrument time, provide the following information about the funding source. If the project is funded by multiple grants, please list all grant numbers and account numbers, and notify the facility manager which one is to be charged at the time of scanning. Contact information for P.I.: Funding Agency: Grant number : Grant Expiration Date: FinMis Account Number: Contact information for Business Administrator.: Funding Agency: Grant number : Grant Expiration Date: FinMis Account Number: For non-Penn investigators, please provide details of the person to whom billing should be sent. Contact information for P.I.: Contact information for Business Administator: Name of person to send billing: Department and Institution : Contact address, phone no., e-mail address etc: 12) Please attach a copy of IRB approval letter and the imaging section of your protocol to this form. NOTE: Your application will not be approved if this information is not provided. Does the research involve human tissue specimens? Yes If yes, when does the IRB protocol approval expire? Are there any risks of contamination? Yes No No Please attach a list of the potential risks and the steps to avoid them. 2 Version 6 -Revised 2/12/16 Human PET Research Approval Form Attach documentation for obtaining the specimens. If bringing in specimens from an outside lab, a letter from infection control is required (Infection Control Office, 215-662-6995). 13) Select the PET scanner, and list all the radioactive tracers that will be used in this project. Philips PET/CT CT contrast agent Philips Allegro Brain G-PET Transmission scan required? Yes Blood sampling required? Yes No *Quantification required? Yes No No *describe if quantification is other than SUV calculation *Tracer(s): 18F-FDG Other 18F-labeled tracers 11C-labeled tracers Other tracers (please specify______________________________________) *Most tracers will be produced by the cyclotron facility. However, if tracers are brought in by other investigators, please provide the name of radiation license holder 14) Describe any additional equipment that will be used in the vicinity of the scanners: 15) Give a brief description of how you plan to use these facilities: 1) describe your imaging protocol, including numbers of patients/yr, numbers of scans/yr, etc; 2) Indicate specific needs regarding data acquisition or image reconstruction. (NB: All of the requested specific information must be included or the application will not be processed or approved). 3 Version 6 -Revised 2/12/16 Human PET Research Approval Form 16) Will any hazardous materials (other than radioactivity) be brought into the imaging facility during this project? Yes No If yes, on a separate page give a description for the precautions that will be taken in the handling of these materials. Also describe clean-up procedures if an accident occurs involving these materials. THIS SECTION TO BE FILLED OUT BY FACILITY DIRECTOR DATE RECEIVED: _____________________ APPROVED: _________ DATE OF REVIEW: ________________________ EXPIRATION DATE:__________________ NOT APPROVED:__________ REASON:_________________________________________________________________________________ _________________________________________________________________________________________ SIGNATURE:____________________________________________________________________________ PRODEV DOLLARS: ____________ACCOUNT CODE : ______________________________EXP:______ FUNDED FINMIS NUMBER: ___________________________________________________________ 4 Version 6 -Revised 2/12/16