Administrative Core

摘要 行政核心将为有能力开展梅毒业务的企业提供管理支持 生产具有全球效力的疫苗所需规模的研究。这样的企业需要1）广泛的 流行病学，公共卫生，临床，转化和基础研究专业知识的基础， 研究者; 2）世界一流的研究基础设施的组合; 3）代表不同的临床研究中心 性传播感染人群，每个人都有经验丰富、忠于职守的行政/支助人员，与当地有着深厚的联系， 患者人群、现场处理标本的能力以及安全传输标本的经验 和数据的合作机构;和4）丰富的管理经验，以连接临床网站 与美国的研究机构合作。拟议的行政核心建立在合作的基础上， 研究和行政网络已经很完善。三位主要参与者 机构与一个或多个外国机构有很深的学术和行政联系， 直接管理或作为合作伙伴管理我们的临床研究中心的国际财团。 这些机构还提供了使该项目成为现实的领导能力、科学和行政技能 可能两位项目负责人都是国际公认的研究科学家， 国际合作和跨学科研究。项目总监带来了丰富的 各种科学领域。一个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，提供所需的行政技能和经验。在此基础上，建议 行政核心将履行五项核心管理职能，作为其具体目标： 上级要员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人提供所有必要的行政协助，协调 促进CRC内部的沟通，提供财务管理，并确保遵守所有 大学和政府法规。(ii)数据管理功能核心数据管理团队将建立 一个中央REDCap系统数据库，将允许无缝，安全，符合HIPAA的人类共享， 相关数据。(iii)统计支持。经验丰富的生物统计学家将为以下方面提供统计支持： 实验设计和数据分析。(iv)培训、职业发展和指导。CRC的 发展和研究计划将培养科学创造力，实验室能力， 独立性，并创造指导机会。(v)symptom社区外展。利用各机构 与当地社区组织的丰富经验，每个站点将进行梅毒社区外展 这些活动将提高患者招募率，建立牢固的社区关系， 为随后的多地点梅毒疫苗试验奠定基础。

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.