Clinical Research & Clinical Trials Office (YDRCTO)
Yale Diagnostic Radiology Clinical Trials Office
Clinical research in the Division of Clinical Radiology is supported by an infrastructure consisting of a Director, the Yale Diagnostic Radiology Clinical Trials Office (YDRCTO) Committee, and 3 clinical research associates, Svetlana Vassilieva, M.D., Patricia Fugal, and Von Potter, M.D.
Dr. Vassilieva is our lead research associate, Ms. Fugal’s focus is in vascular-interventional studies, and Dr. Potter oversees the logistics of requests for imaging services by investigators outside of the Department of Diagnostic Radiology. All three research associates support an array of services in addition to traditional research coordination.
Research Trials Utilizing Imaging Scans:
All research studies utilizing Diagnostic Imaging hospital/affiliated facilities imaging equipment or research studies requesting a Diagnostic Radiology clinical services and clinical research coordinator must be reviewed and approved by the YDR CTO Committee*. All investigators must complete this YDRCTO form (there is a single approval process for both YNHH and the university department).
For trials involving imaging scans in which the sponsor is the payor (ie, non- standard of care imaging scans), additional YNHH hospital approval is required (through the same YDRCTO application form). For Diagnostic Radiology faculty, a separate form is required for imaging trials and clinical research coordinator support - please visit the Clinical Research page on our internal website (requires YDR password & VPN). Patient specific tumor measurement requests must be made via our website Measure Request form. (Tumor Measurement Request Form)
The clinical research coordinators support funded and non-funded research by YDR faculty in the Division of Clinical Radiology. Requests by YDR faculty for coordinator support must be by application through the YDRCTO on the internal website.
Sponsors of funded research utilizing coordinator support have included WL Gore, CR Bard, ACRIN, Cook, Lombard, Medtronic, St Jude Medical, Tenaxis Medical, Bayer, Hologic and Supersonic Imagine.
Awards & Recognitions include: Certificate of Outstanding Contribution from ACRIN, RSNA recognition for contributions to NCI CQIE project, Top enroller for Bart Denali Filter trial, Top enroller for Metronic Rescue Trial, Recognition for exceptional performance from Lombard Pythagoras Trial, Recognition for exceptional performance from Bard CR IVC Filter Trial.
Coordinator Support - Research associates have a wide range of skill sets and can provide assistance in the following areas:
- Coordinate patient recruitment, conduct assessment interviews, and obtain informed consent for potential subjects
- Schedule protocol specific test/procedures and participants' appointments.
- Administer tests, scales and questionnaires to study participants.
- Help PI assess and report adverse events.
- Oversee imaging procedures to ensure adherence to protocol.
- Collect and record protocol specific data.
- Perform follow-up assessments for data collection and AE monitoring.
- Oversee responsibility for drug/device accountability compliance.
- Perform study feasibility assessments in conjunction with YDRCTO committee
- Regulatory: Can help with IRB initial applications, renewals, close-outs, medical record review and AE reporting
- Grants and Contracts: Perform initial review of contracts and submit to GCA office
- Budgets: Perform initial review of budget
- Medicare reimbursement: Obtain CMS reimbursement approvals
- Schedule and oversee site visits from study sponsors including visits for site selection, site initiation, sponsor audits, regulatory agencies and internal or external review boards.
- Represent the department at Investigator Meetings (protocol- specific training).
- PPM: Serve as a Liaison between Diagnostic Radiology and the Patient Protocol Manager department.