1. NM, PET, CT and MR Imaging for Research Projects 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 ORI Registration ORI Registration Vendor Grant Charge Form if utilizing IU Health facilities Vendor Grant Charge Form if utilizing IU Health facilities

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

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 Imaging oversight requirements Imaging oversight requirements

7. Research Reg./Grant Charge Form Grant Charge Form is required for studies being performed in IU Health facilities (UH, Methodist, Riley, IUH-North, IUH-West, NIFS) Grant Charge Form is required for studies being performed in IU Health facilities (UH, Methodist, Riley, IUH-North, IUH-West, NIFS) This is not required for IIBIS In Vivo Imaging Core systems located in R2, UH and future NCOE. This is not required for IIBIS In Vivo Imaging Core systems located in R2, UH and future NCOE.

8. ORI Study Registration Studies must be registered with ORI via website form or you can call/email ORI (317) 274-2321 / ori@iupui.edu Studies must be registered with ORI via website form or you can call/email ORI (317) 274-2321 / ori@iupui.edu ori@iupui.edu Register online at http://ori.medicine.iu.edu/academics/office-for- research-imaging/research-imaging-registration/ Register online at http://ori.medicine.iu.edu/academics/office-for- research-imaging/research-imaging-registration/ http://ori.medicine.iu.edu/academics/office-for- research-imaging/research-imaging-registration/ http://ori.medicine.iu.edu/academics/office-for- research-imaging/research-imaging-registration/ You need the following info to register: You need the following info to register: –Study title –PI Name and email –Funding type (industry/internal/grant) –Modalities involved (MRI, CT, etc) –Expected Start & End dates

9. ORI Study Registration ORI study registration is required prior to our being able to assist in any way: ORI study registration is required prior to our being able to assist in any way: –Budget –Regulatory –Setup/qualification –Archiving –Billing –Scheduling –Etc Radiologist/Imaging scientist collaborators should be identified at this point if possible Radiologist/Imaging scientist collaborators should be identified at this point if possible

10. What We Need to Help You? Appropriate facility forms completed (Vendor grant charge form & ORI reg.) Appropriate facility forms completed (Vendor grant charge form & ORI reg.) 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

11. Who Can Help? Regulatory Assistance Regulatory Assistance –Machine Produced Radiation (A-1b form)  Radiation Safety Office(317) 274-4797  ORI(317) 274-2321  ori@iupui.edu ori@iupui.edu –Injectable Radiotracer (A-1a form)  ORI (317) 274-2321  ori@iupui.edu ori@iupui.edu Radiologic Imaging Budget Assistance Radiologic Imaging Budget Assistance  ORI (317) 274-2321  ori@iupui.edu ori@iupui.edu

12. Who Can Help? Budget (continued) Budget (continued) –IU Health  Medicare Rates for technical –Only if no special imaging requirements. Must be standard of care per IU Health protocol. –IIBIS In-Vivo Imaging Core  Charge by the hour in 15-minute increments.  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

13. 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)  This discount only includes those assessments performed as the standard clinical interpretation. –This DOES NOT include RECIST measurements, completion DTFs, or volume measurements.

14. Thank you!