The primary goal of this CTSA Planning Grant is to develop a robust strategy for the transformation of translational research at the NYU SoM and its affiliated institutions. The Planning Grant will focus on the infrastructure, governance, and mechanisms for establishing a Clinical and Translational Science Institute (CTSI) at the NYU School of Medicine (SoM). This CTSA will build on the strengths of the NYU's General Clinical Research Center (GCRC), its strong clinical and epidemiological research, biostatistical and educational resources, and its legacy of working with diverse ethnic and racial populations. The planning grant will also strengthen collaborations, through graduate programs, data sharing and core infrastructure, among Schools of New York University (Dentistry, Nursing, and Wagner), affiliated academic hospitals and existing institutes within the SoM. In this CTSA Planning Grant we have proposed seven Specific Aims and will establish Working Groups (WGs), which will be charged with addressing issues necessary for the development of a multi-disciplinary, integrative CTSI. The WGs will establish the processes and procedures for linking the investigators/institutions to the CTSI and for utilization of shared resources, priorities for access and use. The WGs will align with the functions of the CTSI and include: 1) Education and Career Development; 2) Data Services and Medical/Bioinformatics; 3) Biostatistics, Study Design and Ethics of Clinical Research; 4) Novel Technologies and Translational Research; 5) Community Engagement; 6) Regulatory Affairs; 7) Participant and Clinical Interactions Resources (PCIR). Each WG will perform a rigorous Needs Assessment, Asset Mapping, Gap Analysis and make Recommendations pertinent to their assigned CTSA functions. WGs will allocate the first three months of planning to needs assessment activities and developing asset maps related to their objectives. Each WG will create an action plan tailored to their responsibilities, goals, and objectives. In Months 4 and 10, retreats will be held that will include the Executive Committee, Steering Committee, the WGs, the External Advisory Committee, key institutional administrative personnel and hired outside consultants with particular expertise in data management, data sharing and interoperability within and across institutions. Throughout the planning period, the WGs will interact primarily through the co-chairs, who are each members of the Steering Committee. During the planning process we will make determinations regarding the institutional resources, the required core infrastructure and the interactions between the CTSI and other components of the SoM. The success of the NYU CTSI will have significant impact on discovery of innovative treatments, the training of future investigators and the sharing of clinical data among investigators that will increase collaborations both within and outside NYU and its affiliated institution. ? ? ?
