Administrative Core

行政核心

• 批准号: 8448511
• 负责人: Betsy C. Herold
• 金额: $ 42.06万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-18 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8448511
• 关键词: Animal Care and Use Committees; Animals; Budgets; Clinical; Clinical Research; Communication; Communities; Complex; Data Analyses; Data Collection; Drug Formulations; Elements; Ensure; Ethics Committees; Goals; HIV; Human Resources; Institutes; Institutional Policy; Institutional Review Boards; Instruction; Laboratories; Local Microbicides; Methods; Mission; Monitor; National Institute of Allergy and Infectious Disease; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Preparation; Publications; Research; Research Personnel; Safety; Sampling; Sexual Transmission; Site; Specimen; Structure; Travel; United States National Institutes of Health; Vaginal Ring; Work; abstracting; clinical research site; dissemination research; high standard; human subject; meetings; member; microbicide; multidisciplinary; nonhuman primate; novel strategies; pre-clinical; programs; success; symposium

PROJECT SUMMARY (See Instructions): The primary objective of this Program is to advance an intravaginal ring formulation of a microbicide combination to safely reduce the sexual transmission of HIV. The overall Program includes 3 Projects and a Scientific Core and is comprised of several critical subcontracts that will enable the scientific team to achieve its goals. The interactions between the investigators, laboratories and clinical research sites are essential to the success of this Program. Consequently, a well-organized, well-defined administrative structure is necessary to optimize the success of this endeavor. The Administrative Core will oversee the day-to-day management of the Program and ensure communication and coordination of all study sites. The members of the Administrative Core will work closely with the investigators, pharmaceutical collaborators, NIH representatives and members of the designated Scientific Advisory Panel. The aims of the Core are to coordinate the fiscal and organizational aspects of the Program. The Core will be responsible for maintaining and reviewing budgets and will facilitate research related travel. In addition, administrative staff will be responsible for the procurement of non-human primates for studies in Projects 1 and 2 as well as overseeing the shipment of clinical samples between the sites. The Administrative Core staff will arrange all study related conference calls and annual meetings. The Core will also provide guidance to the Program Director, Project and Core Leaders for smooth, inter-institutional complex interactions, including assistance with subcontracts, IRB, and Clinical Research Center submissions and identifying and resolving unanticipated problems.

项目摘要（参见说明）： 该计划的主要目标是推进杀微生物剂组合的阴道环制剂，以安全地减少艾滋病毒的性传播。整个计划包括 3 个项目和一个科学核心，并由几个关键的分包合同组成，这些分包合同将使科学团队能够实现其目标。研究人员、实验室和临床研究中心之间的互动对于该计划的成功至关重要。因此，需要一个组织良好、明确的行政结构来优化这一努力的成功。行政核心将监督该计划的日常管理，并确保所有研究中心的沟通和协调。行政核心成员将与研究人员、制药合作者、NIH 代表和指定科学顾问小组成员密切合作。核心的目标是协调该计划的财政和组织方面。核心将负责维护和审查预算，并促进与研究相关的旅行。此外，行政人员将负责采购用于项目 1 和 2 研究的非人类灵长类动物，并监督临床样本在站点之间的运输。行政核心人员将安排所有与研究相关的电话会议和年会。核心还将为项目总监、项目和核心领导者提供指导，以实现机构间复杂的互动，包括协助分包合同、IRB 和临床研究中心提交文件，以及识别和解决意外问题。