Administrative Core

摘要 行政核心将为有能力进行梅毒的企业提供管理支持 研究生产具有全球效力的疫苗所需的规模。这样的事业需要一位广泛的 ITS的流行病学、公共卫生、临床、翻译和基础研究专业知识基础 研究人员；2)世界级研究基础设施的组合；3)代表不同类型的临床地点 STI人群，每个人都有经验丰富、尽职尽责的行政/支持人员，与当地有很深的联系 患者群体、现场处理样本的能力以及安全传输样本的经验 和数据到协作机构；以及4)连接临床站点的丰富管理经验 与美国的研究机构合作。拟议的管理核心建立在协作的基础上 已经建立起来的研究和行政网络。三位主要参与者都参与了 院校与一所或多所外国机构或 直接管理我们临床站点或作为管理我们临床站点的合作伙伴的国际财团。 这些机构还提供领导以及科学和管理技能，使该项目 有可能。两位项目负责人都是国际公认的研究科学家，具有丰富的研究经验 国际合作和跨学科研究。项目总监带来了丰富的知识 各种科学领域。来自主要机构的经验丰富的管理人员团队将汇集不同的 背景，提供必要的管理技能和经验。在此基础上，建议的 行政核心将执行五项核心管理职能作为其具体目标：(一)管理和 疏忽。指导委员会将概述里程碑和时间表，并跟踪进展情况。《核心》 管理团队将为项目和核心领导提供所有需要的行政协助，协调 并促进儿童权利委员会内部的沟通，提供财务管理，并确保遵守所有 大学和政府的规定。(Ii)数据管理。核心数据管理团队将建立 一个中央红帽梅毒数据库，将允许无缝、安全、符合HIPAA的人-梅毒共享 相关数据。(三)统计支撑。经验丰富的生物统计学家将为 实验设计和数据分析。(4)培训、职业发展和指导。儿童权利委员会的 开发和研究计划将培养科学创造力、实验室能力和智力 独立，并创造指导机会。(V)梅毒社区外展。在他们的 与当地社区组织有丰富的经验，每个站点都将进行梅毒社区推广 将增加患者登记并建立牢固的社区关系的活动，为 为随后的多点梅毒疫苗试验奠定了基础。

ABSTRACT The Administrative Core will provide managerial support for an enterprise capable of conducting syphilis research on the scale required to produce a vaccine with global efficacy. Such an enterprise requires 1) a broad base of epidemiologic, public health, clinical, translational, and basic research expertise among its investigators; 2) a combination of world-class research infrastructures; 3) clinical sites representing diverse STI populations, each with experienced, committed administrative/support personnel, deep local ties to patient populations, on-site capacity to process specimens, and experience securely transmitting specimens and data to collaborating institutions; and 4) a wealth of administrative experience to connect clinical sites with research institutions in the United States. The proposed Administrative Core builds upon collaborative research and administrative networks that are already well-established. All three principal participating institutions have deep academic and administrative ties to one or more of the foreign institutions or international consortia that directly administer or serve as partners in the management of our clinical sites. These institutions also provide the leadership and scientific and administrative skills that make the project possible. Both project leaders are internationally recognized research scientists with extensive experience with international collaboration and interdisciplinary research. The Project Directors bring deep knowledge of a rich variety of scientific fields. A team of seasoned administrators from the principal institutions will pool diverse backgrounds, providing needed administrative skills and experience. Building on this foundation, the proposed Administrative Core will implement five core managerial functions as its Specific Aims: (i) Management and Oversight. The Steering Committee will outline milestones and timelines and track progress. The Core managerial team will provide Project and Core Leaders with all needed administrative assistance, coordinate and promote communication within the CRC, provide financial management, and ensure compliance with all university and government regulations. (ii) Data Management. The Core data management team will establish a central REDCap Syphilis Database that will allow seamless, secure, HIPAA-compliant sharing of human- related data. (iii) Statistical Support. Experienced biostatisticians will provide statistical support for experimental design and data analysis. (iv) Training, career development, and mentorship. The CRC's Development and Research Program will foster scientific creativity, laboratory competence, and intellectual independence, and create mentorship opportunities. (v) Syphilis community outreach. Drawing on their extensive experience with local community organizations, each site will conduct syphilis community outreach activities that will enhance patient enrollment and establish strong community relationships, laying the foundation for a subsequent multi-site syphilis vaccine trial.