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

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
What you need?

Regulatory approval
– IRB
– Radiation Safety (not needed for US or MRI)
Study Imaging Requirements & Budget
Information
 ORI Registration
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Vendor Grant Charge Form if utilizing IU
Health facilities
Regulatory Approval:
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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
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
 Imaging oversight requirements

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)
 This is not required for IIBIS In Vivo Imaging Core
systems located in R2, UH and future NCOE.

ORI Study Registration
Studies must be registered with ORI via website form
or you can call/email ORI (317) 274-2321 /
[email protected]
 Register online at
http://ori.medicine.iu.edu/academics/office-forresearch-imaging/research-imaging-registration/
 You need the following info to register:
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Study title
PI Name and email
Funding type (industry/internal/grant)
Modalities involved (MRI, CT, etc)
Expected Start & End dates
ORI Study Registration
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ORI study registration is required prior to our being
able to assist in any way:
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Budget
Regulatory
Setup/qualification
Archiving
Billing
Scheduling
Etc
Radiologist/Imaging scientist collaborators should be
identified at this point if possible
What We Need to Help You?
Appropriate facility forms completed
(Vendor grant charge form & ORI reg.)
 Copy of IRB approval (when received)
 Protocol documents:
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– Study protocol
– Supplemental Imaging protocol/addendum
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Study contact at IU & Sponsor for imaging
related questions
Who Can Help?

Regulatory Assistance
– Machine Produced Radiation (A-1b form)
 Radiation Safety Office
 ORI (317) 274-2321
 [email protected]
(317) 274-4797
– Injectable Radiotracer (A-1a form)
 ORI (317) 274-2321
 [email protected]
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Radiologic Imaging Budget Assistance
 ORI (317) 274-2321
 [email protected]
Who Can Help?

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
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)
 This discount only includes those assessments
performed as the standard clinical interpretation.
– This DOES NOT include RECIST measurements,
completion DTFs, or volume measurements.
Thank you!