Clinical Research Services

The Clinical Research Services (CRS) is a Shared Resource comprised of the Clinical Trials Office and Office of Protocol Review and Monitoring, as well as resources for contracts and budgeting and protocol development. A Steering Committee, Protocol Review Committee, and Data Safety Monitoring Committee oversee all clinical trial activities for Yale Cancer Center, along with the Institutional Review Board (IRB) and Human Investigations Committee (HIC) at Yale School of Medicine.

To support the development and implementation of clinical trials at YCC, tools and expertise are provided to investigators, including templates for clinical protocols and consent forms to assist clinical investigators in the development, editing and formatting of clinical protocols, as well help coordinating the budgets, contracts, IND (if applicable), protocol approvals, and maintenance of an on-line web-based protocol and consent retrieval system for YCC. That support includes:

The Budgeting Unit provides trained, professional support and guidance in budget development and negotiations for the YCC faculty. All proposed YCC clinical trials must be reviewed by this unit. This area works with investigators, department business staff, and sponsors to develop and negotiate budgets in support of the cancer center’s mission and in accordance with both internal and external policy.

Contact: ycc.ctobudgets@yale.edu

The Post Award Management Unit is responsible for monitoring and reporting on expenses and revenue for clinical trials. The unit works with the Principal Investigators, clinical trial study personnel, ancillary departments, and sponsors in support of the cancer center’s mission. Managing revenue and expenses for clinical trials is crucial to ensure the effective allocation of resources, adherence to budget, billing compliance, and successful execution of the study.

Contact: ycc.ctoinvoices@yale.edu

Clinical Trials Coordination is the fundamental role of the Clinical Trials Office including support of clinicalinvestigators in initiating and conducting clinical trials, and collecting and preparing clinical trial data for reports from the trials. All trials must be registerd with the CTO, for supervision and support including a study of feasibility before a trial is activated; to ensure regulatory requirements are met; to coordinate all clinicalresearch at the institution; to manage data; for specimen processing to name a few.

Contact: Sara Raboin, PhD; director of CTO Operations.

The YCC CTO Quality and Education Unit supports investigators and study teams, facilitating excellence and quality in clinical research efforts. This includes providing educational resources and training initiatives tailored for faculty and research staff. The unit identifies and facilitates Standard Operating Procedures (SOPs) that improve and guarantee that initiatives are seamlessly incorporated with quality standards across the research continuum and that research activities are aligned with relevant regulations and policies, while prioritizing the safety and protection of human participants.

Contact: Jessica Rowe, MA, MS, CCRP, CIP; Quality and Education Director

OnCore is a suite of clinical and translational research modules with software for clinical research, patient registry and biospecimen management. Yale Cancer Center, YCCI, and other staff use OnCore for protocol entry and administration, subject enrollment and management, and SAE and deviation tracking. Access to the system is provided as needed to individuals who work directly in an area where OnCore has been formally implemented. They system can be accessed at https://oncore.ynhh.org. If you are not a registered OnCore user or if you would like additional information, contact oncore.support@yale.edu.

The Clinical Research Support Laboratory (CRSL) at Yale Cancer Center is an in-service provider ensures that biospecimen samples from clinical trial patients are processed, stabilized, and submitted to the appropriate final analyzing labs.

Support Lab locations:
• Yale New Haven Hospital – Smilow Cancer Center (North Pavilion)
35 Park Street, NP8-109, New Haven
• Yale University Medical School Campus, Sterling Hall of Medicine
333 Cedar Street, SHM IE-65, New Haven
• Smilow Cancer Hospital Care Center—Trumbull
5520 Park Ave, WP-1-350, Trumbull
• Smilow Cancer Hospital Care Center—North Haven
6 Devine Street, Rm 4-085, North Haven,
• Smilow Cancer Hospital at Saint Francis
94 Woodland Street, 2nd Floor, Hartford
• Smilow Cancer Center Hospital at Stamford
260 Long Ridge Road, Stamford

Clinical Trial Tissue Services (CTTS)
310 Cedar Street, LMP 100, New Haven