Office for Research Imaging (ORI) - Indiana Institute for Biomedical

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IU Health
Office for
Research Imaging
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Research
o Getting Started
o What information does my scan require?
o New Studies
o Exisiting Studies
o Preclinical Services Registration
o Radiation Safety Assistance
o IIBIS Research Development Initiative
Clinical Trials
o Radiation Safety Assistance
o Imaging Guided Biopsy Registration
o Scheduling
o Research Imaging Registration
Research Imaging Rates
o IU Health Research Imaging Rates
Forms and Resources
o People Mover Status
o Expanded Access Acetate and Ga-DOTA-NOC
 Overview of 68Ga-DOTA-NOC at IU
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Research
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Office for Research Imaging (ORI)
Forms and Resources
Office for Research Imaging (ORI)
Who we are: The Office for Research Imaging (ORI) within the Department of Radiology and
Imaging Sciences and Indiana Institute for Biomedical Imaging Sciences (IIBIS) is the dedicated
research support team for Investigators and their staff to promote and facilitate the use of
biomedical imaging in research and clinical trials. We understand the challenging nature of
performing clinical research in a major academic medical center. More importantly, we
understand how to successfully plan and implement complex imaging protocols within the vast
resources offered in our academic medical center and vast hospital network.
What we do: ORI supports all research and clinical trials of the IIBIS (Indiana Institute for
Biomedical Imaging Sciences) along with the IU Simon Cancer Center, IU Health University
Hospital, Riley Hospital for Children at IU Health, IU Health Methodist Hospital, and IU Health
Neuroscience Center of Excellence. ORI is able to provide world class imaging support through
collaboration with our highly skilled Radiologists and Imaging Scientists along with our clinical
and research support staff.
Why we do it: Study protocols are both technically and logistically complex, specifically in a
large academic medical center. It takes a team of dedicated staff working together to successfully
open and implement a research imaging protocol. ORI has registered well over 1,000 studies and
provided differing levels of support based on the protocol needs. We understand that more
studies are adding complicated and often novel imaging procedures to their study protocols. We
are here to help navigate through the channels that often do not have clear paths.
How we do it: ORI utilizes project management tools designed specifically for research
imaging organization. We are experienced at working directly with imaging CRO’s to carefully
manage all aspects of imaging protocols. We are here to help you through all of the study set up
procedures and training, provide a dedicated research scheduling team, implement study specific
imaging acquisition guidelines, and transmit de-identified electronic imaging data in compliance
with all university and federal guidelines. The tools are easily shared with the study team so that
everyone from the PI, budget team, regulatory team, imaging technologists, and study
coordinators can work together in support of these projects. Please ask about our SharePoint
project management sites if you are interested in collaboration.
ORI was established to provide an exclusive imaging support resource for researchers
utilizing both industry and PI generated studies. To help you get started with your
research imaging we have provided eight basic steps:
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Register your study
Budget
Regulatory
Site Qualification
Study Set-Up
Scheduling
Billing Method and Fees
Data Services
1. Register your study
It's never too early to contact ORI with study questions or service requests. In fact, the earlier the
better! To initiate imaging in your research study, please submit a completed research imaging
registration form, budget request (if needed), and protocol (when received) to ori@iupui.edu.
Upon submission the study will be reviewed by a radiologist and/or imaging scientist for
approval. At registration, the study will be assigned an ORI study I.D. number. This study I.D.
number will be the identifier for scheduling, invoicing, and all other study communique with
ORI. A research imaging registration form must be submitted before ORI can respond to
ANY study request.
Contacting ORI is easy, just email us @ ori@iupui.edu or call 317-963-7228. We have dedicated
staff waiting to assist you with all of your research imaging needs.
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2. Budget
Requesting a Budget Quote for a New Study:
When requesting a budget quote for a new study: Register your study first by completing the
ORI study registration form. When registering, make sure to check “Budget Quote” under the
Research Services section. We generally can have your imaging budget back to you within 5-7
business days. Depending upon the complexity of the imaging study we may have to consult
hospital coders, technologists, and IUH revenue cycle staff for exam pricing verification. The
study may be charged one of two ONE-TIME startup & maintenance fees:
1. Startup Fee for industry funded clinical trials with Image Acquisition Guidelines $2,525
2. Startup Fee for industry funded clinical trials with routine imaging protocol & research
services $1,587.50
If the study has no imaging acquisition guidelines, and no research services (no budget
assistance, no radiation safety assistance, no protocol guidelines to follow, no site qualification
forms, no research scheduling, no research reads, no data transfers, & no training sessions, etc.)
other than performing a routine scan and diagnostic read then no additional fees will be charged
to support the study. We still ask that these studies register with ORI to assure accurate reporting
of radiology resources. If you are unable to determine which fee to budget for, you may request
the sponsor to complete our pre-trial questionnaire for sponsors.
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3. Regulatory
ORI has dedicated staff to assist you with all of your imaging regulatory requirements. Services
include but are not limited to: regulatory applications, dosimetry calculations, and protocol
development. If your study requires any of these services, please email ORI with your request
and we will reply within 24 hours. Regulatory approvals (IRB, SRC, Radiation Safety, etc.) must
be submitted to ORI before imaging can begin. If you are not sure what kind of regulatory
requirements your scan requires, click here.
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4. Site Qualification
Site Qualification forms should be submitted to ORI and completed by our certified Research
Imaging Technologists. Each study may require specific and evolving data that is best completed
by a research imaging technologist. Please let us complete these forms for you to ensure
accuracy and expediency. Forms can be submitted here.
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5. Study Set-Up
Once the study has submitted a research imaging registration form, protocol, and all regulatory
documents to ORI we will begin pre-study preparations. This includes but is not limited to: study
startup meetings, study document creation, database builds, research scheduling orders, phantom
scans and imaging protocol Q/C, etc.
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6. Scheduling
You can schedule your study participants via email @ orisched@iupui.edu or by phone at (317)
963-7228.
When scheduling please have the following information:
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Study ID#
Subject Name
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Subject ID
Visit number
Read or No Read
Scan type & Location
HOW TO ORDER RESEARCH SCANS: ORI has developed a Research Order for all studies
that have specific imaging guidelines to follow. The order may be prepopulated with identifying
study information that allows our imaging technologists to successfully scan the subjects per the
study acquisition guidelines. At the bottom of the order you will find the scheduling email and
phone number to contact for your study. The research order should be sent to ORI after
scheduling along with the IUH/IUHP Grant Charge Forms. Studies performed at IIBIS do not
require an order or IUH/IUHP grant forms.
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7. Billing
Billing Methods and Fees
IIBIS
Research imaging studies performed at IIBIS by IU investigators are charged by the hour
through the IUSOM financial system. Study PI’s and staff will receive an email receipt detailing
the procedure charges and study account number of record every evening after a study is
performed. IIBIS imaging systems are dedicated IU research imaging systems with trained
research imaging technologists who specialize in research protocols. Hourly billing rates can be
found on the IIBIS rates page and are applicable July 1- June 30. These rates are published for
informational purposes only and all studies should request a formal budget estimate for each
study. Studies should budget for annual 3-5 increase in rates.
Professional services by a Radiologist, Imaging Scientist, or radiology staff member may be
financially supported through salary support of the named individual on the grant or billed as a
fee for service through the IUSM financial system. If a study requires a named Radiologist or
Imaging Scientist as a Co-Investigator or therein equal role to assuming oversight of the imaging
protocol and/or study analysis, then named salary support should be utilized. External
investigators and industry sponsors should inquire directly with ORI for applicable study rates.
Federal grant applications with imaging services should include Radiology faculty and/or staff as
salary support listed on the grant.
IU Health
Research imaging studies performed at IU Health are billed by the IU Health Revenue Cycle
Services. Billing questions should be directed to Camille Gilliam or Sana a Smith at IU Health
Revenue Cycle Services. IU Health charges research studies the CMS reimbursement rate based
on CPT code. If the exam does not have a reimbursable CPT code then the exam is given a 65%
discount of the list rate. The ORI can provide exam pricing for your study, however it is up to the
study to provide the CPT codes associated with the protocol imaging requirements. ORI is not
responsible for obtaining the CPT codes that correspond with the study requirements; however
we will help as much as we possibly can to assist you with obtaining the correct coding. All
research studies performed at IU Health must have grant charge forms created by IUH Revenue
Cycles Services before scheduling exams.
Research imaging studies performed at IU Health and interpreted by an IUHP Radiologist
receive a 65% discount for diagnostic professional interpretations. This applies for research
exams performed per our routine site imaging protocols and require a routine interpretation.
Additional charges and/or salary support will apply if the study requires specific research
reporting that otherwise would not be included in a routine diagnostic exam interpretation. Study
specific dictation/reporting/form completion may be billed via ORI and the IUSOM financial
billing system if Radiology salary support is not included in the budget. Routine diagnostic
interpretations for research studies are billed through IU Health Revenue Cycle Services.
Please inquire with ORI for pricing. ORI has created an Imaging Questionnaire for Sponsors to
assist coordinators and business personnel with determining budget considerations. Please have
the study sponsor’s project manager complete this form and return to ORI for an accurate budget
estimate.
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8. Data Services
Data Archival, Transfer, and Anonymization
All studies are electronically archived and saved for 15+years. Studies requiring electronic
transfer and anonymization will be charged $29 per exam. Study coordinators should email ORI
with a data transfer request form attached to execute a data transfer. Exam raw data may be
available for 1-2 days after scanning.
Imaging Budget Assistance
Regulatory Assistance (IRB language for imaging, dosimetry, and radiation safety
assistance)
Site Qualification form completion
Protocol Review and Design
Research Scheduling
RECIST and tumor measurements
Specialty Research Reads
Electronic Data Transfer
Data Anonymization
Database builds
IU Health Grant charge form assistance
Research Binder creation and delivery
Rates:
Industry funded with study specific imaging protocol: $2,525
Industry funded routine ( no specific imaging criteria): $1,587.50
Rate includes:
Protocol review by Radiology staff and Radiologist
Electronic data transfer setup and testing
Budget Assistance
Radiation Safety Assistance
Study Qualification & Initiation
Study Maintenenance
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