Yale Diagnostic Radiology Clinical Trials Office Email:YDRCTO@yale.edu
|Kevin Kim, MD|
Director of Clinical Trials
|Elizabeth Correa, MA|
Coordinator, Imaging Support Services
|Patricia Fugal, MS, CCRP|
|Eliot Funai, CCRP|
|Svetlana Vassilieva, MD, MS|
TIMC Technical Coordinator
|Teresa White, BSN, OCN,CCRP|
Clinical Research Nurse
TUMOR IMAGING METRICS CORE - TIMC
The mission of TIMC is to provide standardized, longitudinal radiological measurements to evaluate therapeutic responses for clinical trials
TIMC tracks changes in lesion size, which is essential for clinical trials that use radiological measurements as surrogate endpoints. Yhe system manages these images and takes measurements in a routine and centralized method.
Imaging Support Services
Imaging Support Services manages the imaging components of the Yale Cancer Center’s clinical trials from budget and feasibility through close out. Staff reviews sponsor and cooperative group protocols, imaging acquisition guidelines, and imaging manuals to identify standard and non-standard imaging to ensure feasibility. This includes determining the appropriate fees and imaging resources for project completion, completing the image transfer out of PACs to the sponsors for all disease teams, and serving as the primary contact for sponsors and central vendors. ISS also manages the clinical research radiology approvals for non-standard imaging/pricing and assists in coordinating YCC biopsies for IR.
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).
Radiology Information Data Retrieval
To request clinical data from YNHH imaging reports, please complete the IDXrad Database Search Form (using support document: Exam & CPT codes). All retrieval requests must have HIC approval. There is a fee of $200 per request for non-YDR faculty in order to support this activity. Data retrieval may take 2 weeks. For Diagnostic Radiology faculty & trainees, please use the process described on the internal website under Clinical Research (requires YDR password & VPN).
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). Cindy Voghell can assist with all TIMC questions. Cindy can be reached by emailing YDRCTO@yale.edu or calling 203-785-5942.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 TIMC (https://ydrcto.precisionmetrics.org).
*Note: Imaging research performed at the MRRC or Research PET Centers is reviewed separately and under the jurisdiction of the Division of Bioimaging Sciences.
Support for Diagnostic Radiology Department Faculty & Trainees
For Yale Diagnostic Radiology faculty and trainees, please visit our Clinical Research webpage on our internal website (YDR Clinical Research requires YDR password & VPN). This site provides information regarding support for conducting productive imaging research including information regarding research coordinator support, statistics support, funding sources, Yale University support gateways to programs and infrastructure, the IRB, training and compliance requirements, and requisite forms. You can also find a compendium of information with resource links devoted to supporting faculty research, including the Yale Sponsored Projects Handbook and Principal Investigators Policies on the Office for Faculty Policies website.