PHACS Data Resources Core

项目摘要/摘要 PHACS数据资源核心(DRC)(首席调查员(PI)：George R.Seage III，DSC，公共卫生部门)将 提供整体计划项目管理，容纳合并后的数据库，并提供编程和 儿科艾滋病毒/艾滋病队列研究(PHACS)2020 P01计划项目的分析领导。刚果民主共和国 将继续与PHACS临床站点以及Westat，Inc.和Frontier Science签订分包合同 和技术研究基金会(“FSTRF”)，该基金会将支持监测临床站点和数据 分别进行管理操作。 在PHACS 2020中，DRC的目标将是： 1.制定和指导PHACS 2020核心和 研究项目。 2.执行和管理合作伙伴和临床站点的分包合同。 3.为单一内部审查委员会(Sirb)流程以及监管和合规管理提供支持 临床站点。 4.利用其与临床地点及其人员的关系和直接接触，包括 临床研究人员、研究人员和社区咨询委员会(CAB)成员，以高效和 有效地实施所有PHACS2020研究项目，并管理和监控绩效。 5.作为PHACS 2020的集中数据和资源管理实体。 6.提供样品跟踪、管理样品存储和监督实验室数据管理。 7.管理数据存储和访问。 8.监督和执行PHACS样本和数据的共享和传输以及接收 用于协作的数据。 9.为综合数据分析提供方案编制和分析核心服务。 10.作为所有PHACS 2020核心和研究项目的共享资源。 刚果民主共和国将设在哈佛大学公共卫生学院(HSPH)，在日常工作中 PHACS项目主管、EDM利兹·所罗门的行政领导。私人投资经理及员工 PHACS核心领导(DRC，科学管理核心，健康教育和社区核心，以及 流行病学和统计方法核心)以及PHACS FSTRF分包合同的PI，Sue Siminski，硕士，MBA和Westat分包商，Julie Davidson，MSN将每周开会，以促进协调 在为研究项目服务的核心之间。每月的会议和定期沟通将 DRC和PHACS临床研究人员、研究人员和驾驶室之间也会发生这种情况。

Project Summary/Abstract The PHACS Data Resources Core (DRC) (Principal Investigator (PI): George R. Seage III, DSc, MPH) will provide overall program project management, house the merged database, and provide programming and analytical leadership for the Pediatric HIV/AIDS Cohort Study (PHACS) 2020 P01 Program Project. The DRC will continue to subcontract with PHACS clinical sites as well as Westat, Inc. (“Westat”) and Frontier Science and Technology Research Foundation (“FSTRF”) which will support monitoring of clinical sites and data management operations respectively. In PHACS 2020, the aims of the DRC will be to: 1. Develop and direct the overarching Project Management Plan for the PHACS 2020 Cores and Research Projects. 2. Execute and manage subcontracts for collaborating partners and clinical sites. 3. Provide support to the Single IRB (sIRB) process and regulatory and compliance management for clinical sites. 4. Utilize its relationship with and direct access to clinical sites and their personnel, including Clinical Investigators, Study Staff and Community Advisory Board (CAB) members, to efficiently and effectively implement all PHACS 2020 Research Projects and manage and monitor performance. 5. Serve as the centralized data and resource management entity for PHACS 2020. 6. Provide sample tracking, manage sample storage, and oversee laboratory data management. 7. Manage data storage and access. 8. Oversee and execute the sharing and transfer of PHACS samples and data as well as the receipt of data for collaborations. 9. Provide programming and analytical core services for integrated data analysis. 10. Serve as a shared resource to all PHACS 2020 Cores and Research Projects. The DRC will be based at the Harvard T.H. Chan School of Public Health (HSPH) under the day-to-day administrative leadership of the PHACS Program Director, Liz Salomon, EdM. The PIs and the staff of the PHACS Core leadership (DRC, Scientific Administrative Core, Health Education and Community Core, and Epidemiological and Statistical Methods Core) as well as the PIs of the PHACS FSTRF subcontract, Sue Siminski, MS, MBA and the Westat subcontract, Julie Davidson, MSN will meet weekly to facilitate coordination between the Cores in service to the Research Projects. Monthly meetings and regular communications will also occur between the DRC and PHACS Clinical Investigators, Study Staff and CABs.