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.
Complete NMRO Application
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.