How to Set Up a Research Study
There are four steps for setting up a research study:
- Protocol Development
- Nuclear Medicine Research Operations Committee(NMROC) Application
- Review by NMROC
- Scheduling
Protocol Development
Every protocol that involves studies that will be done in a manner that differs from the standard clinical PET/CT protocols must have a Nuclear Medicine Authorized User (AU) involved in the Protocol Development and listed on the protocol (please follow the links for a description of the standard protocols and a listing of the AUs on the Meet Our Team page). The AU can help in the development of a protocol that will target the particular hypothesis being studied while ensuring adequate image quality and maintaining superior clinical standards of excellence.
If you are having difficulty finding an AU, please contact:
David Mankoff, MD, PhD
Vice-Chair for Research, Department of Radiology
Director, PET Center, Nuclear Medicine
215-615-3687
david.mankoff@uphs.upenn.edu
Please contact Erin Schubert to discuss the study charges. The study charges are not guaranteed for the length of a research study. They are subject to change with approval by the School of Medicine.
Learn more about the funding process and obtain required documents for submission
Nuclear Medicine Research Application
The Nuclear Medicine Research application form includes information about the people associated with the research study and some specifics about the equipment and radiopharmaceuticals that will be used for the studies. If you are unsure about how to answer a particular question, please contact the AU associated with your protocol for guidance.
Any questions that are left unanswered or are answered incompletely may delay the review and approval while clarification is obtained.
Learn more and complete the application
Review by Nuclear Medicine Research Operations Committee
Your application must be reviewed and approved by the IRB (Institutional Review Board), the RRSC (Radiation Research Safety Committee), and NMROC. Each committee has a different focus and, as such, the approval of the protocol by the individual committees is done in concert.
The final approval will come from the IRB, once both the RRSC and NMROC have approved the protocol. Study participants cannot be scheduled until final approval from the IRB is received.
Scheduling
Scheduling is study specific and will be discussed with your study team at the study start up meeting. In general the following rules will apply:
- Study subjects cannot be scheduled until final IRB approval is granted (including RRSC approval), an RBN is established and your team has completed a study start up meeting if required.
- All PET/CT research studies, unless otherwise specified, must be scheduled by emailing PETCT_RschSchedule@uphs.upenn.edu with scheduling requests. Specific scheduling instructions will be provided for all new studies before the Nuc Med study start up meeting
- Activity request forms will be created specifically for your study if the Penn Cyclotron is producing the tracer. Any limitations on timing of scans or days that research scans can be performed will communicated to you before you start your study.
- All PET/CT research studies will have a Research Protocol Scan Form created by the NMROC (except for standard-of-care scans, as determined by NMROC). A signed copy of this form must accompany the patient on the day of their PET/CT scan. Any changes to this form must be approved and implemented by NMROC administrator or designee.
To schedule standard-of-care FDG PET/CT or other general nuclear medicine (e.g. bone scan, MUGA scan) research studies, call Radiology scheduling at 215-662-3000, once the PennChart order has been entered.
Scheduling in the dedicated research slots are based on availability within the defined schedule. Research scanner time slots on our the Philips Ingenuity scanner are listed below:
Monday: 3-5 pm
Tuesday: 1-5 pm
Wednesday: 1-5 pm
Thursday: 12-5 pm
Friday: 12-5 pm