NEW CLINICAL TRIAL - Radiology review, study qualification, setup and Clinical Trials Imaging Instruction (CTII) form creation
NOTE: If all of the imaging for your trial is paid routine care (no study/sponsor paid imaging at any time-point), and there are no special imaging guidelines or imaging qualification requirements, then new trial Radiology review/setup is generally not required.
To submit a new clinical trial for Radiology review, please submit a new trial Radiology review/setup request in iLab. Please be sure to attach ALL study documents to the application (study protocol, imaging guidelines, surveys, qualification forms, training requirements, etc).
Fees for our review/setup processes do NOT include pricing for clinical exams. Clinical exam pricing requests should be submitted to the Clinical Trials Billing Compliance Office via Starbrite. Please do not submit pricing requests for imaging procedures to Radiology.
Your new trial will need to be submitted via iLab for core review/setup If the trial includes:
An imaging component with any sponsor-paid imaging (check billing plan) AND/OR sponsor-mandated image acquisition parameters (hint: there’s usually a separate imaging manual provided by the sponsor or central imaging vendor) AND/OR there are sponsor-mandated imaging qualification requirements.
The imaging is performed in one of the imaging departments under our core’s umbrella:
-Vanderbilt University Hospital (Adult Radiology)
-The Vanderbilt Clinic (TVC-Radiology)
-Vanderbilt Orthopedic Institute (VOI-Radiology)
-Center for Women's Imaging (CWI-Crystal Terrace/One Hundred Oaks)
-One Hundred Oaks (OHO) Breast Center
-Vanderbilt Children's Hospital (Pediatric Radiology)-effective 4/2/2018
-Cardiac MRI (VHVI)-effective 5/1/2018
Tentative: Vanderbilt Imaging Services-VIS (OHO/Hillsboro/Belle Meade/Cool Springs/Spring Hill). VIS is currently undergoing consideration for transition to core processes.
-VUMC Study Short Name
-Sponsor's Study Title
-Study Coordinator/Group Leader
-Does the sponsor require completion of a survey, or require that the imaging modalities pre-qualify for the study?
Note: Pre-qualification can include: Site survey, TEF (Technical Evaluation Form), ICQ (Imaging Capabilities Questionnaire), submission of test or phantom images, etc. Please attach all pre-qualification/survey documents at the bottom of this application. If qualification requirements are only available in e-mail format, please e-mail qualification information to firstname.lastname@example.org.
-Does the sponsor/central reader require that the imaging technologists complete any training?
-Is Radiology attendance at SIV required by sponsor?
-How will imaging be reimbursed?
All imaging will be billed Routine Care
All imaging will be billed to study/sponsor
Billing will be visit specific (some Routine Care and some to study/sponsor)
-Please list ALL imaging procedures that will be included in this study.
Examples: MRI Brain, CT Chest/Abd/Pelvis, NM Bone Scan, PET Whole Body, CXR, US guided biopsy, etc.
-If PET studies are included on this trial, will an investigational (IND) radio-tracer be used for PET imaging?
-Will image data be sent to sponsor or central reader?
Note: When requested, image data will be de-identified and re-identified with sponsor requested information (i.e. study ID number, site number, timepoint, etc.), then burned to a disc and submitted to the study coordinator. Upon receipt of disc, the study coordinator has the option to upload data to sponsor/central reader, or send via courier service. Electronic submission (e-transfer) of image data directly from Radiology has very limited availability; please e-mail email@example.com for further information. Please see the "Disc/Image Data Request" section for more information.
-Are there special imaging requirements/guidelines for this study?
Note: Imaging Acquisition Guidelines (IAG) or Imaging Manual must be submitted before full radiology review can be completed. Please attach imaging guidelines to this application.
Note: Our equipment/scanners are continually upgraded as needed. We cannot guarantee software and hardware versions and equipment manufacturers continuity for the study duration.
-If this study requires that a specific radiologist be in charge of imaging, please provide name of radiologist
-Estimated study start date
-How long is study expected to last?
-How many patients do you expect to enroll?
-VUMC Radiologist interpretation:
ALL READ: All imaging exams should receive clinical report
ALL NO-READ: No imaging exams should receive clinical report*
MIXED-READ: Only some imaging exams should receive a clinical report*
*If VUMC radiologist interpretation is NOT required for this trial, please be prepared to explain which exams should not be read, and why.
-Billing Plan # (if available)
-IRB # (if available)
-eSMART ID# (if available)
-Will imaging be performed as inpatient or outpatient or ER?
-Patient population? (Adult and/or Pediatric
After your iLab submission is received:
Your application and study documents are reviewed by core manager
A quote will be sent to you with an estimate of fees associated with our services
You agree to the quote (and ensure that there is a valid center number on iLab request)
A full Radiology review will be performed, to include review by each modality involved
Imaging equipment and staff will be prepared for trial PRN
Any requested Radiology qualifications will be completed (surveys, etc)
Imaging exam list (based on Radiology review of study protocol and imaging guidelines) will be submitted to CTBC via eSmart
CTBC will reconcile the imaging exam list provided by Radiology with the billing plan provided by the clinic
Clinical Trials Imaging Instructions (CTII) form for the trial is drafted and approved by core team
Radiology computer system (RIS/Imagecast) setup is requested and verified
Radiology setup information is added to the eSMART project prior to study creation in EPIC
Clinical Trial Imaging Instructions (CTII) form is finalized and sent to clinic
Hyperlink to CTII form is populated on eStar study page when trial is setup in EPIC by CTBC team
Please refer to "Status Dashboard" to determine Radiology review/setup status of your new trial submission.
Core review/qualification/setup processes currently take approximately 7-8 weeks, however complex trials will required extended time.
Most new trial review/setup will flow as follows:
Core has been made aware of study via automated email notification of Starbrite billing plan submission or contact from researcher. Core has notified researcher that submission of application, study protocol and imaging manual via iLab is required for Radiology review/setup.
-iLab submission received, but not yet processed
Researcher has submitted new trial review/setup request via iLab, but core has not yet reviewed or processed submission.
-Quote Approval or Center # Pending
Core has performed an initial review of available study documents (at no charge) and created a quote for estimated core charges. Researcher will need to agree to core charges and supply a valid cost center number for core charges. Valid center/billing number must be activated in the iLab billing system.
-Review/Qualification/Setup In Progress
Core team is currently reviewing all study documents to determine feasibility and to determine exact type of imaging required for clinical trial. If required, core team will complete all necessary qualification (surveys, training, phantom scans, etc) and prepare scan equipment for trial. Specialized protocols are loaded on imaging equipment PRN.
-Awaiting Billing Plan/eSMART ID#
Billing plan must be submitted via Starbrite/eSMART prior to core exam code reconciliation with Clinical Trials Billing Compliance office. Core will receive automatic email notification from eSMART when trials with imaging component are submitted.
-Radiology Exam List submitted to eSmart
When eSMART ID# is available, core review findings will be submitted via eSMART for CTBC review. CTBC team will review imaging exam list supplied by core, and will reconcile with the trial's billing plan. CTBC will identify and resolve any discrepancies with regards to imaging portion of trial.
-Draft Instructions (CTII) Form Review In Progress
Based on feedback from core team, a draft Clinical Trial Imaging Instructions (CTII) form will be created. Draft CTII is then reviewed for accuracy by all Radiology departments (modalities) participating in the trial.
-Imagecast setup In Progress
Core submits IT request for a study-specific "modifier" to be loaded into the Radiology Information System (RIS) which is named Imagecast.
-Radiology setup info entered into eSmart
CTII hyperlink information is entered onto eSMART links tab for the trial. Radiology "read" status, Radiology modifier#, and core sign-off are entered onto eSMART imaging tab for the trial.
Core review/qualifications/setup for new trial are complete.
Other status types:
CTII forms cannot be finalized until IRB# is available.
Reasons for "on hold" status vary. Contact core for specifics on your trial.
-Amendment review in progress
Core review/setup processes are complete, however, researcher has now provided protocol or imaging guideline amendment from sponsor. Core will review new study documents and complete new qualification requirements as needed. CTII forms will be revised as needed.
-Additional qualification in progress
All Radiology review and set up processes are complete, however, new qualification requirements (surveys, training, phantom scans, etc) have now been provided to core.
Trial will not open to accrual per researcher. Common reasons are failed budget negotiations or FDA approval of study drug, etc.
-Completed, but training still pending
Core review and set up processes are complete, however, the sponsor has not provided the required imaging technologist training information,
-Std of Care: Imaging exams all paid & performed SOC, no core review needed
Per information supplied during billing plan submission or based on information received from researcher, all imaging will be performed and paid routine care. Radiology review/setup processes are not normally required for these types of trials.
-All imaging to be performed outside of Rad Support Core purview
Core initially notified of Radiology-based imaging component of trial, however it was later determined that all imaging would be performed at imaging facility that is not under the core umbrella (VHVI, VUIIS, etc).
Link to iLab registration instructions: https://medschool.vanderbilt.edu/oor/ilab-solutions-registration-instructions
iLab login link: https://vumc.corefacilities.org/account/login
Link to iLab user support: https://www.vumc.org/oor/ilab-user-support-user-guides-users-vumc-core-groups
iLab support/Office of Research email: VUMCcores@vumc.org