NM, PET, CT and MR NM, PET, CT and MR Imaging for Research Imaging for Research

ProjectsProjects

What You Need, What We Need and What You Need, What We Need and Who Can Help YouWho Can Help You

Presented by Wendy Winkle, BSPresented by Wendy Winkle, BS

What you need?What you need? Regulatory approvalRegulatory approval

– IRBIRB– Radiation Safety Radiation Safety (not needed for US or MRI)(not needed for US or MRI)

Study Imaging Requirements & Study Imaging Requirements & Budget InformationBudget Information

ORI RegistrationORI Registration

Vendor Grant Charge Form Vendor Grant Charge Form if utilizing IU if utilizing IU Health facilitiesHealth facilities

Regulatory Approval:Regulatory Approval:

IRBIRB– May need to include Radiologist, May need to include Radiologist,

Imaging Scientist, Imaging Imaging Scientist, Imaging Technologists as Co-ITechnologists as Co-I

– If subjects will receive radiation dose If subjects will receive radiation dose that is NOT part of their Standard that is NOT part of their Standard Clinical Care you will need to detail this Clinical Care you will need to detail this in your application where appropriate in your application where appropriate (consent, etc)(consent, etc)

Regulatory Approval:Regulatory Approval: Radiation Safety ApprovalRadiation Safety Approval

– Required for PET, PET-CT, Nuclear Required for PET, PET-CT, Nuclear Medicine, CT, X-ray, Medicine, CT, X-ray, Interventional/Fluoro, AcceleratorInterventional/Fluoro, Accelerator

– Studies involving injectable radiotracers Studies involving injectable radiotracers A-1a form completed & submitted to RSOA-1a form completed & submitted to RSO

– Calculation of dose to patientCalculation of dose to patient– Description of use, radiotracer, QA/QC, & Rad Description of use, radiotracer, QA/QC, & Rad

Safety procedures & areasSafety procedures & areas– Section I, Section III.1 and III.2 completed by PISection I, Section III.1 and III.2 completed by PI

approval from the Radiation Safety Permit approval from the Radiation Safety Permit Holder responsible required Holder responsible required

Regulatory Approval:Regulatory Approval:

– Studies involving Machine-Produced Studies involving Machine-Produced Radiation (X-ray, CT, Fluoro, Radiation (X-ray, CT, Fluoro, Accelerator)Accelerator) A-1b form completed & submitted to RSOA-1b form completed & submitted to RSO

– Radiation dose estimateRadiation dose estimate– Description of useDescription of use

Does not require Radiation Safety Permit Does not require Radiation Safety Permit Holder approval/signatureHolder approval/signature

Study Imaging Study Imaging Requirements:Requirements: Need information to determine system Need information to determine system

requirements, scan protocol, patient requirements, scan protocol, patient dose dose (where applicable), (where applicable), and budgetand budget– Study protocolStudy protocol– Imaging protocol/addendum/supplementImaging protocol/addendum/supplement– Radiotracer specifications Radiotracer specifications (where applicable)(where applicable)

Sponsor Site Qualification formSponsor Site Qualification form Imaging oversight requirementsImaging oversight requirements

Research Reg./Grant Charge Research Reg./Grant Charge FormForm

Grant Charge Form is required for studies Grant Charge Form is required for studies being performed in IU Health facilities being performed in IU Health facilities (UH, (UH, Methodist, Riley, IUH-North, IUH-West, NIFS)Methodist, Riley, IUH-North, IUH-West, NIFS)

This is not required for IIBIS This is not required for IIBIS In VivoIn Vivo Imaging Imaging CoreCore systems located in R2, UH and future systems located in R2, UH and future NCOE.NCOE.

ORI Study RegistrationORI Study Registration Studies must be registered with ORI via website Studies must be registered with ORI via website

form or you can call/email ORI (317) 274-2321 / form or you can call/email ORI (317) 274-2321 / ori@iupui.edu ori@iupui.edu

Register online at Register online at http://ori.medicine.iu.edu/academics/office-for-http://ori.medicine.iu.edu/academics/office-for-research-imaging/research-imaging-research-imaging/research-imaging-registration/ registration/

You need the following info to register:You need the following info to register:– Study titleStudy title– PI Name and emailPI Name and email– Funding type (industry/internal/grant)Funding type (industry/internal/grant)– Modalities involved (MRI, CT, etc)Modalities involved (MRI, CT, etc)– Expected Start & End datesExpected Start & End dates

ORI Study RegistrationORI Study Registration

ORI study registration is required prior to our ORI study registration is required prior to our being able to assist in any way:being able to assist in any way:– BudgetBudget– RegulatoryRegulatory– Setup/qualificationSetup/qualification– ArchivingArchiving– BillingBilling– SchedulingScheduling– EtcEtc

Radiologist/Imaging scientist collaborators Radiologist/Imaging scientist collaborators should be identified at this point if possibleshould be identified at this point if possible

What We Need to Help You?What We Need to Help You?

Appropriate facility forms completed Appropriate facility forms completed (Vendor grant charge form & ORI reg.)(Vendor grant charge form & ORI reg.)

Copy of IRB approval (when received)Copy of IRB approval (when received) Protocol documents:Protocol documents:

– Study protocolStudy protocol– Supplemental Imaging Supplemental Imaging

protocol/addendumprotocol/addendum Study contact at IU & Sponsor for Study contact at IU & Sponsor for

imaging related questionsimaging related questions

Who Can Help?Who Can Help? Regulatory AssistanceRegulatory Assistance

– Machine Produced Radiation (A-1b form)Machine Produced Radiation (A-1b form) Radiation Safety OfficeRadiation Safety Office (317) 274-4797(317) 274-4797 ORIORI (317) 274-2321(317) 274-2321 ori@iupui.edu ori@iupui.edu

– Injectable Radiotracer (A-1a form)Injectable Radiotracer (A-1a form) ORI (317) 274-2321ORI (317) 274-2321 ori@iupui.edu ori@iupui.edu

Radiologic Imaging Budget Radiologic Imaging Budget AssistanceAssistance

ORI (317) 274-2321ORI (317) 274-2321 ori@iupui.edu ori@iupui.edu

Who Can Help?Who Can Help? Budget Budget (continued)(continued)

– IU HealthIU Health Medicare Rates for technicalMedicare Rates for technical

– Only if no special imaging requirements. Must be Only if no special imaging requirements. Must be standard of care per IU Health protocol.standard of care per IU Health protocol.

– IIBIS IIBIS In-Vivo Imaging CoreIn-Vivo Imaging Core Charge by the hour in 15-minute increments. Charge by the hour in 15-minute increments. Suggest using IIBIS for more complex studiesSuggest using IIBIS for more complex studies

– PET or PET-CTPET or PET-CT– Complex MRI studies such as fMRIComplex MRI studies such as fMRI– Studies that do not follow standard clinical imaging Studies that do not follow standard clinical imaging

guidelines/protocolsguidelines/protocols

Who Can Help?Who Can Help? Budget (continued)Budget (continued)

– Indiana Radiology Partners (IRP)Indiana Radiology Partners (IRP) IRP now offers 60% discount on professional IRP now offers 60% discount on professional

fee for clinical interpretation for researchfee for clinical interpretation for research Define role of radiologistDefine role of radiologist

– Standard clinical interpretationStandard clinical interpretation– Completion of study specific forms requiredCompletion of study specific forms required– Responsible for radiologic imaging at study site Responsible for radiologic imaging at study site

(may be required on Site Qualification Form)(may be required on Site Qualification Form)

This discount only includes those assessments This discount only includes those assessments performed as the standard clinical performed as the standard clinical interpretation. interpretation.

– This DOES NOT include RECIST measurements, This DOES NOT include RECIST measurements, completion DTFs, or volume measurements.completion DTFs, or volume measurements.

Thank you!Thank you!