Core A: Administration

核心A：管理

• 批准号: 10532091
• 负责人: Deborah J Anderson
• 金额: $ 21.26万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10532091
• 关键词: Achievement; Adherence; Antibodies; Antibody Formation; Antigen Targeting; Atopobium vaginae; Award; Biological; Blood; Boston; Clinical; Clinical Data; Clinical Management; Clinical Trials; Clinical Trials Database; Communication; Contraceptive Agents; Contraceptive methods; Data; Development; Ensure; Environment; Experimental Designs; Film; Funding; Goals; Grant; Guidelines; HIV-1; Human; Human Herpesvirus 2; IgG1; Immobilization; Individual; Industrialization; Industry; Infertility; Infrastructure; Leadership; Libraries; Liquid substance; Methods; Monitor; Monoclonal Antibodies; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Nicotiana; Performance; Phase I Clinical Trials; Positioning Attribute; Preclinical Testing; Prevention; Program Reviews; Publications; Reagent; Research; Research Personnel; Research Project Grants; Resource Allocation; Safety; Schedule; Scientist; Sexually Transmitted Diseases; Site; Specificity; Sperm Agglutination; Statistical Data Interpretation; Technology; Testing; Translational Research; United States National Institutes of Health; Universities; Vagina; Vaginal Route of Drug Administration; Woman; base; clinical database; data acquisition; data management; data sharing; experience; innovation; medical schools; meetings; pathogen; pre-clinical; programs; research and development; sperm cell; statistical service; statistics; success; symposium; web site

ADMINISTRATIVE CORE – ABSTRACT The Contraception Research Center at Boston University School of Medicine (BUSM-CRC) brings together an experienced team of clinical, industrial and basic scientists to develop and test a new contraceptive product, ZB- 06, a vaginal film that releases an antisperm antibody, Human Contraception Antibody (HCA). HCA was originally isolated from the blood of an infertile but otherwise healthy woman and targets an antigen on sperm to effect rapid sperm agglutination and immobilization. Success of the BUSM-CRC relies upon an Administrative Core that provides scientific and administrative leadership in coordinating the two contraception development research projects and one contraceptive translational research project that make up the program. The Administrative Core will also maintain the clinical database and provide statistical services, and coordinate data and materials acquisition and sharing so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones, The Specific Aims of the Administrative Core are: 1. To provide scientific leadership and administrative oversight. Specifically, the Administrative Core will establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource allocation and changes to the experimental design. The Administrative Core will also convene an external Scientific Advisory Panel (SAP) to review the program annually. The Administrative Core will facilitate communication through scheduled conference calls and investigator meetings, provide financial and administrative support, and insure adherence to institutional and federal guidelines. 2. To coordinate data and materials acquisition and sharing to insure that project and program milestones are met. The Administrative Core will be responsible for the reagent/research material and data management and sharing plan, and for monitoring milestone achievements. 3. To manage the clinical database and statistical analysis for the two clinical trials.

行政核心 - 摘要 波士顿大学医学院（BUSM-CRC）的避孕研究中心汇集了一个 经验丰富的临床，工业和基础科学家团队，开发和测试新的避孕产品ZB- 06，一种阴道膜，可释放抗体抗体，人类避孕抗体（HCA）。 HCA是 最初是从不育而健康的女性血液中孤立的，并将其靶向精子上的抗原 影响快速的精子凝集和固定。 BUSM-CRC的成功依赖于行政 在协调两种避孕开发方面提供科学和行政领导的核心 研究项目和一个组成该计划的避孕转化研究项目。这 行政核心还将维护临床数据库并提供统计服务并协调数据 以及材料的获取和共享，以便以综合迭代方式进行研究以满足 个人项目和程序化里程碑， 行政核心的具体目的是： 1。提供科学领导和行政监督。具体而言，行政核心将 建立一个执行委员会（EC），以持续评估项目和核心里程碑，资源 分配和实验设计的变化。行政核心还将召集外部 科学咨询小组（SAP）每年审查该计划。行政核心将喜欢 通过计划的电话会议和调查员会议进行沟通，提供财务和 行政支持，并确保遵守机构和联邦准则。 2。协调数据和材料获取和共享以确保该项目和计划 满足了里程碑。行政核心将负责试剂/研究材料和数据 管理和共享计划，以及监视里程碑成就。 3。管理两个临床试验的临床数据库和统计分析。