Transcript Radiologic Imaging at IU

Radiologic Imaging at IU
What You Need, What We Need and Who
Can Help You
Presented by Wendy Winkle, BS
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)
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)
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
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
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
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)

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
Who Can Help?

Regulatory Assistance
– Machine Produced Radiation (A-1b form)
 Radiation Safety Office
 IIBIS (Wendy Winkle)
(317) 274-4797
(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
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
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)
Thank you!