Radiologic Imaging at IU

1. Radiologic Imaging at IU What You Need, What We Need and Who Can Help You Presented by Wendy Winkle, BS

2. What you need? • Regulatory approval • IRB • Radiation Safety (not needed for US or MRI) • Study Imaging Requirements & Budget Information • Research Registration/Grant Charge Form if utilizing Clarian facilitiesOR IIBIS PI Checklist if utilizing Indiana Institute for Biomedical Imaging Sciences (IUSM Research Core)

3. Regulatory Approval: • IRB • May need to include Radiologist, Imaging Scientist, Imaging Technologists as Co-I • If subjects will receive radiation dose that is NOT part of their Standard Clinical Care you will need to detail this in your application where appropriate (consent, etc)

4. Regulatory Approval: • Radiation Safety Approval • Required for PET, PET-CT, Nuclear Medicine, CT, X-ray, Interventional/Fluoro, Accelerator • Studies involving injectable radiotracers • A-1a form completed & submitted to RSO • Calculation of dose to patient • Description of use, radiotracer, QA/QC, & Rad Safety procedures & areas • Section I, Section III.1 and III.2 completed by PI • approval from the Radiation Safety Permit Holder responsible required • Charge for industry sponsored studies

5. Regulatory Approval: • Studies involving Machine-Produced Radiation (X-ray, CT, Fluoro, Accelerator) • A-1b form completed & submitted to RSO • Radiation dose estimate • Description of use • Does not require Radiation Safety Permit Holder approval/signature

6. Study Imaging Requirements: • Need information to determine system requirements, scan protocol, patient dose (where applicable), and budget • Study protocol • Imaging protocol/addendum/supplement • Radiotracer specifications (where applicable) • Sponsor Site Qualification form

7. Research Reg./Grant Charge FormOR IIBIS PI Checklist • Research Registration/Grant Charge Form is required for studies being performed in Clarian facilities (UH, Methodist, Riley, NIFS) • IIBIS PI Checklist Form is required for studies being performed on Indiana Institute for Biomedical Imaging Sciences research systems (UH, R2)

8. What We Need to Help You? • Appropriate facility form completed(Grant Charge Form / PI Checklist) • Copy of IRB approval (when received) • Protocol documents: • Study protocol • Supplemental Imaging protocol/addendum • Study contact at IU & Sponsor for imaging related questions

9. Who Can Help? • Regulatory Assistance • Machine Produced Radiation (A-1b form) • Radiation Safety Office (317) 274-4797 • IIBIS (Wendy Winkle) (317) 278-3167 • Injectable Radiotracer (A-1a form) • IIBIS (Wendy Winkle) (317) 278-3167 • Radiologic Imaging Budget Assistance • Jason Taylor (Clarian) (317) 216-2850 • Wendy Winkle (Clarian/IIBIS) (317) 278-3167

10. Who Can Help? • Budget (continued) • Clarian • 60% discount on imaging technical fee • Now “limited scan” available in most modalities with reduced fee for applicable studies • IIBIS • Charge by the hour in 15-minute increments. Usually cost is less than Clarian facilities • Suggest using IIBIS for more complex studies • PET or PET-CT • Complex MRI studies such as fMRI • Studies that do not follow standard clinical imaging guidelines/protocols

11. Who Can Help? • Budget (continued) • Indiana Radiology Partners (IRP) • IRP now offers 60% discount on professional fee for clinical interpretation for research • Define role of radiologist • Standard clinical interpretation • Completion of study specific forms required • Responsible for radiologic imaging at study site (may be required on Site Qualification Form)

12. Thank you!