Radiologic Imaging at IU

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Radiologic Imaging at IU

• What You Need, What We Need and Who Can Help You
• Presented by Wendy Winkle, BS

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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 facilities OR IIBIS PI
  Checklist if utilizing Indiana Institute for
  Biomedical Imaging Sciences (IUSM Research Core)

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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)

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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

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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

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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

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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)
• IIBIS PI Checklist Form is required for studies
  being performed on Indiana Institute for
  Biomedical Imaging Sciences research systems (UH,
  R2)

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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

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Who Can Help?

• Regulatory Assistance
• Machine Produced Radiation (A-1b form)
• Radiation Safety Office [phone]
• IIBIS (Wendy Winkle) [phone]
• Injectable Radiotracer (A-1a form)
• IIBIS (Wendy Winkle) [phone]
• Radiologic Imaging Budget Assistance
• Jason Taylor (Clarian) [phone]
• Wendy Winkle (Clarian/IIBIS) [phone]

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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

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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)

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Thank you!