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 Regulatory approval –IRB –Radiation Safety (not needed for US or MRI) Study Imaging Requirements & Budget Information Study Imaging Requirements & Budget Information Research Registration/Grant Charge Form if utilizing Clarian facilities OR IIBIS PI Checklist if utilizing Indiana Institute for Biomedical Imaging Sciences (IUSM Research Core) Research Registration/Grant Charge Form if utilizing Clarian facilities OR IIBIS PI Checklist if utilizing Indiana Institute for Biomedical Imaging Sciences (IUSM Research Core)

3. Regulatory Approval: IRB 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 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 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 Sponsor Site Qualification form

7. Research Reg./Grant Charge Form OR IIBIS PI Checklist Research Registration/Grant Charge Form is required for studies being performed in Clarian facilities (UH, Methodist, Riley, NIFS) 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) 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) Appropriate facility form completed(Grant Charge Form / PI Checklist) Copy of IRB approval (when received) Copy of IRB approval (when received) Protocol documents: Protocol documents: –Study protocol –Supplemental Imaging protocol/addendum Study contact at IU & Sponsor for imaging related questions Study contact at IU & Sponsor for imaging related questions

9. Who Can Help? Regulatory Assistance 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 Radiologic Imaging Budget Assistance –Jason Taylor (Clarian)(317) 216-2850 –Wendy Winkle (Clarian/IIBIS) (317) 278-3167

10. Who Can Help? Budget (continued) 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) 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!