PHACS Data Resources Core

PHACS 数据资源核心

• 批准号: 10663912
• 负责人: George R Seage
• 金额: $ 1371.5万
• 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/10663912
• 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; Resources; Sampling; Sampling Studies; Science; Services; Statistical Methods; Technology; Time; clinical research site; data access; data integration; 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.

项目概要/摘要 PHACS 数据资源核心 (DRC)（首席研究员 (PI)：George R. Seage III，DSc，MPH）将 提供整体项目管理，容纳合并数据库，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力。 将继续与 PHACS 临床中心以及 Westat, Inc.（“Westat”）和 Frontier Science 分包 和技术研究基金会（“FSTRF”），将支持临床站点和数据的监测 分别进行管理操作。 在 PHACS 2020 中，DRC 的目标是： 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中心的分包合同。 3. 为单一 IRB (sIRB) 流程以及监管和合规管理提供支持 临床场所。 4. 利用其与临床场所及其人员的关系并直接接触临床场所及其人员，包括 临床研究者、研究人员和社区咨询委员会 (CAB) 成员，以高效、 有效实施所有 PHACS 2020 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、管理样品存储并监督实验室数据管理。 7. 管理数据存储和访问。 8. 监督执行PHACS样本和数据的共享、传输以及回执 的合作数据。 9、提供集成数据分析的编程和分析核心服务。 10. 作为所有 PHACS 2020 核心和研究项目的共享资源。 DRC 将设在哈佛大学陈曾熙公共卫生学院 (HSPH)，负责日常工作。 PHACS 项目总监 Liz Salomon、EdM 的行政领导 PI 和工作人员。 PHACS 核心领导力（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，MS、MBA 和 Westat 分包合同的 Julie Davidson，MSN 将每周会面以促进协调 为研究项目服务的核心之间将每月举行会议并定期进行沟通。 DRC 和 PHACS 临床研究者、研究人员和 CAB 之间也发生这种情况。