New York University School of Medicine CTSA Planning Grant

描述(由申请者提供)：CTSA规划基金的主要目标是为纽约大学SOM及其附属机构的翻译研究转型制定一个强有力的战略。规划补助金将侧重于在纽约大学医学院(SOM)建立临床和转化科学研究所(CTSI)的基础设施、治理和机制。这一CTSA将建立在纽约大学综合临床研究中心(GCRC)的优势、其强大的临床和流行病学研究、生物统计学和教育资源以及与不同民族和种族人口合作的遗产的基础上。规划拨款还将通过研究生项目、数据共享和核心基础设施，加强纽约大学各学院(牙科、护理和瓦格纳)、附属学术医院和SOM内现有机构之间的合作。在这份CTSA规划赠款中，我们提出了七个具体目标，并将建立工作组(WGS)，负责解决发展多学科、综合CTSI所需的问题。工作组将制定程序和程序，将调查人员/机构与CTSI联系起来，并利用共享资源、获取和使用的优先事项。WGS将与CTSI的职能保持一致，包括：1)教育和职业发展；2)数据服务和医疗/生物信息学；3)临床研究的生物统计学、研究设计和伦理；4)新技术和翻译研究；5)社区参与；6)管理事务；7)参与者和临床互动资源(PCIR)。每个工作组将执行严格的需求评估、资产映射、差距分析，并提出与其分配的CTSA职能相关的建议。工作组将把头三个月的规划工作分配给需求评估活动和编制与其目标有关的资产图。每个工作组将制定一份针对其职责、目标和目的的行动计划。在第4个月和第10个月，将举行务虚会，参加人员包括执行委员会、指导委员会、工作组、外部咨询委员会、主要机构行政人员，并聘用在机构内部和机构间具有数据管理、数据共享和互操作性方面专门知识的外部顾问。在整个规划期间，工作组将主要通过作为指导委员会成员的联合主席进行互动。在规划过程中，我们将就机构资源、所需的核心基础设施以及CTSI与SOM的其他组成部分之间的互动作出决定。纽约大学CTSI的成功将对创新疗法的发现、未来研究人员的培训以及研究人员之间的临床数据共享产生重大影响，这将增加纽约大学及其附属机构内外的合作。

DESCRIPTION (provided by applicant): 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.