PHACS Data Resources Core

PHACS 数据资源核心

• 批准号: 10065442
• 负责人: George R Seage
• 金额: $ 1343.12万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-18 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10065442
• 关键词: Acquired Immunodeficiency Syndrome; Biometry; Clinical Data; Clinical Investigator; Clinical Management; Collaborations; Communication; Communities; Data; Data Analyses; Data Storage and Retrieval; Databases; Epidemiologic Methods; Epidemiology; Foundations; Health education; Human Resources; Institutional Review Boards; Laboratories; Leadership; Monitor; Pediatric HIV/AIDS Cohort Study; Performance; Principal Investigator; Process; Program Research Project Grants; Public Health Schools; Research; Research Project Grants; Resource Sharing; Sampling; Sampling Studies; Science; Services; Statistical Methods; Technology; Time; base; clinical research site; data access; data management; data resource; frontier; meetings; member; operation; programs

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.

项目摘要/摘要 PHACS数据资源核心（DRC）（主要研究员（PI）：George R. Seage III，DSC，MPH） 提供整体计划项目管理，容纳合并的数据库，并提供编程和 小儿艾滋病毒/艾滋病队列研究（PHACS）2020 P01计划项目的分析领导。 DRC 将继续与PHACS临床站点以及Westat，Inc。（“ Westat”）和Frontier Science分包合同 和技术研究基金会（“ FSTRF”），该基金会将支持对临床站点和数据的监视 管理操作分别。 在2020年的PHAC中，刚果民主共和国的目标将是： 1。制定并指导PHACS 2020核心的总体项目管理计划 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。为单个IRB（SIRB）流程以及法规和合规管理提供支持 临床部位。 4。利用其与临床站点及其人员的关系并直接访问 临床研究人员，研究人员和社区顾问委员会（CAB）成员，有效， 有效地实施所有PHAC 2020研究项目并管理和监视绩效。 5。作为PHACS 2020的集中数据和资源管理实体。 6。提供样品跟踪，管理样本存储并监督实验室数据管理。 7。管理数据存储和访问。 8。监督并执行PHACS样本和数据的共享和转移以及收据 合作的数据。 9。提供编程和分析核心服务以进行集成数据分析。 10。作为所有PHAC 2020核心和研究项目的共享资源。 刚果民主共和国将位于哈佛T.H.日常公共卫生学院（HSPH） PHACS计划总监Liz Salomon，EDM的行政领导。 PIS和工作人员 PHACS核心领导力（DRC，科学行政核心，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PIS Siminski，MS，MBA和Westat分包合同，朱莉·戴维森（Julie Davidson），MSN每周见面以举办协调 在为研究项目服务的核心之间。每月会议和常规沟通将 还发生在DRC和PHACS临床研究人员，研究人员和出租车之间。