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" section of the PET Center landing 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.
Please contact Erin Schubert to discuss an appropriate AU and any 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.
Application
The NMRO application provides us with important specifics regarding the proposed research study, including:
- Key personnel
- Expected recruitment
- Exam type/frequency
- Radiopharmaceutical
- Imaging data management requirements/needs
Fill out the application completely. Any questions left unanswered or incompletely answered may delay the review and approval of your protocol while clarification is obtained.
If you are unsure about how to answer a particular question, please contact Erin Schubert for guidance.
The application submission deadline is one week prior to NM Research Operations Committee convened review.
Research studies involving PET/CT imaging that differ from standard clinical PET/CT exams must have at least one Authorized User (AU) involved in protocol development.
Authorized User
An Authorized User (AU) is a licensed physician that meets requirements as defined by the Nuclear Regulatory Commission (NRC) Regulations (10 CFR) part 35.
Research studies may need to involve the participation of an AU if they include the use of an investigational radiopharmaceutical that is not FDA approved. If you have questions about this requirement or need to know if there is an AU available to participate in your study please contact Erin Schubert for that information.
Research Billing Number
Every research protocol in Nuclear Medicine or PET will receive a Research Billing Number (RBN). The RBN links your particular study to your funding source (usually a FinMis Account). The RBN is a nine-digit number.
A study participant cannot be scheduled for a scan until the RBN is obtained.
Many research studies will be required to have a Study Start Up Meeting prior to activation of the RBN.
Study Start Up Meeting
Many research studies will require a study start up meeting prior to scheduling the first subject for their research exam(s). You will be in contact with Erin Schubert to schedule a start up meeting if required.
Meetings are typically brief and will involve the key personnel from your study team and our Nuclear Medicine/PET Center team.
The meetings provide a venue to review all processes to make sure the necessary elements are in place to carry out the study.
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.
Any research protocol with a Nuclear Medicine or PET/CT component requires review by the Nuclear Medicine Research Operations Committee(NMROC).
The NMROC is composed of Nuclear Medicine faculty physicians, PENN Cyclotron faculty, Physics and Instrumentation faculty, Nuclear Medicine Manager, PET Center Administrator and PET Research Project Manager.
The NMROC meets on the first Wednesday of each month and reviews protocols that have been submitted to the PET Center and have undergone IRB and RRSC review in preparation for protocol implementation and opening.
Review Requirements
Your protocol must be in the process of review and approval by the Institutional Review Board (IRB) before the committee will review.
Your protocol must be: (1) reviewed and approved or (2) withheld approval pending minor changes by the Radiation Research Safety Committee (RRSC) before it is considered for NMROC review.
Limited studies can be reviewed in an expedited manner, particularly if the imaging component follows routine clinical practice.
If you have questions about protocols that are early in the development stage that have not been submitted to the IRB/RRSC yet please contact Erin Schubert.
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