The Yale Center for Clinical Investigation (YCCI)

The Yale Center for Clinical Investigation was established in the fall of 2005 incorporating the GCRC within its structure. YCCI was virtually identical in its vision, design, and scope with that later proposed in the RFA for CTSA applications. Steps were taken prior to the CTSA submission to establish some components of YCCI, including renovation of a new outpatient facility. The funding of the CTSA at Yale in October, 2006 (P.I. R. Sherwin) has greatly accelerated the development of YCCI, and in the process will undoubtedly strengthen clinical and translational research as well as training in diabetes as well as provide new cost savings opportunities for the DERC to partner with YCCI.

YCCI Operations Center

The Operations Center will house all YCCI personnel who are needed to assist investigators in the development, implementation and oversight of clinical and translational research studies.

Functions of the Operations Center include:

• Responsibility for all of the Regulatory Knowledge and Support activities of YCCI
• Identification and dissemination of information regarding new research opportunities from NIH, foundations and industry
• Assist PI's with determination of study needs, development of study budgets, and preparation of grant submissions,
• Assist in development of research protocols and consents,
• Ensure that adequate space will be available for implementation of successful grant applications
• Assist with research subject recruitment
• Certify the competences of YCCI research staff (e.g., nurse coordinators, research assistants, and data managers) involved in the implementation of study protocols and to monitor staff performance,
• Coordinate activities of Research Subject Advocates who will monitor the conduct of studies and protection of human subjects, and
• Office space at the Operations Center for Informatics, Biostatistics, Protocol Development, IRB, Recruitment, Management and Grants and Contracts staff to assist investigators in the development of study protocols; submission of grant applications; preparation of case report forms; plans for data management and data analyses; staffing and other resource requirements; regulatory compliance and study oversight.

The new Operations Center provides the infrastructure to support YCCI's as well as the DERC's mission to effectively support clinical and translational investigators at Yale in the development, implementation and oversight of their studies. All of the resources that are needed for every aspect of cutting-edge studies will be available at one site. The Operations Center will provide a critical point of contact for industry and the staff in the Operations Center will work to identify new research opportunities that are matched to appropriate investigators. Dr. William V. Tamborlane serves as the Director of the Operations Center. In this role he is ideally placed to facilitate the development and successful implementation of the new DERC Diabetes Translational Core.

YCCI Outpatient Clinical Translational Research Center

The need for YCCI to develop a new outpatient facility for the performance of minimal and low risk outpatient studies was given a high priority, and as a result, it will become fully operational in November, 2006. This facility includes:

• Examining rooms and office space for clinical research personnel (i.e., RN and APRN nurse coordinators, patient care associates, research assistants and bionutritionists),
• Reception area and waiting room,
• Treatment rooms for minimal and low risk procedures,
• Consultation rooms,
• Phlebotomy room,
• Blood and other sample processing facility,
• Research pharmacy services,
• Freezers and refrigerators for blood and tissue specimens to be stored in a safe and secure location,
• Storage space, locked supply and medication room,
• Space for receptionists (who will document subject visits and provide scheduling services) and administrative assistants, Small conference area.

The importance of the new Outpatient Center extends beyond simple enhancement of space for clinical studies. Having a central location for outpatient studies will facilitate cost-effective utilization of research staff (e.g., nurse coordinators) that may be engaged in studies with more than one investigator, as well as oversight of ongoing studies. Use of YCCI research staff will free investigators of many of the burdens of administrating the day-to-day management and enhance the quality of supervision and oversight of research staff. Integration of activities of the YCCI Outpatient Clinical and Translational Research Center and the Operations Center will be facilitated by locating both important components of our program in the same location. It should also be noted that the site at 2 Church Street South was selected because it is in close proximity to the academic offices of research faculty in the Yale School of Nursing and EPH, as well as the School of Medicine. The outpatient center will also serve as a training and certification site for new study coordinators and research assistants.

YCCI Analytical Core Laboratory

This resource originally served as the core laboratory of the GCRC. Because a major strength of the GCRC was in patient-based diabetes-related research, the primary orientation of this laboratory has been substrate, hormone and cytokine analyses, and thus directly relevant to DERC research programs. As a result, this facility's technical staff and equipment are an important resource for human-based diabetes research and offer a valuable cost savings to the DERC. The DERC Physiology Core is therefore able to exclusively focus its limited resources on the measurement of hormones from rats and mice experiments. The laboratories consist of a 125 sq. ft blood processing laboratory, a 250 sq. ft laboratory for substrate measurements and a 750 sq. ft laboratory equipped for immunoassays, HLPC /ELISA analyses and tissue culture. Recently, the resources of the YCCI Analytical Core have been enhanced by CTSA funding including: new equipment (Luminex) and creation of a freezer farm for sample/DNA storage.

Other YCCI Research Cores

Designed to optimize effective use of modern research technologies by clustering them around common themes. There are 6 such clusters: (1) imaging (cellular and human-based research); (2) clinical laboratory methods; (3) physiological and metabolic procedures; (4) cognitive and behavioral methods; (5) methods for drug and device development; and (6) methods for the production of cells and vectors. YCCI developed this type of clustering to overcome the problem often encountered by new investigators, namely the difficulty of having to seek out a patchwork of informal input from a variety of centers and core laboratories. YCCI will now provide an integrated mechanism for this purpose. Within YCCI, a sub-committee devoted to Yale-wide optimal integration of core resources will be established, composed of the directors of core laboratories and representatives from their user groups. This committee will serve as a referral resource, connecting investigators with the appropriate cores and triggering an informal iterative process to help each investigator choose the most appropriate methodologies for his/her project. In parallel, YCCI is in the process of constructing a website to provide on-line descriptions of all cores.