Operations and Collaborations Center - Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional)

运营与合作中心 - HIV/艾滋病干预青少年医学试验网络 (ATN) 运营与合作中心（UM2 临床试验可选）

• 批准号: 10599566
• 负责人: Barbara Driver
• 金额: $ 419.24万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2029-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10599566
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adolescent Medicine Trials Network; Agreement; Clinical; Clinical Trials; Collaborations; Communication; Communities; Development; Devices; Documentation; Dropout; Enrollment; Ensure; Funding; Goals; Good Clinical Practice; HIV-infected adolescents; Infrastructure; Intervention; Intervention Studies; Investigation; Investigational Drugs; Knowledge; Laboratories; Lead; Leadership; Logistics; Manuals; Measures; Methodology; Modification; Monitor; National Institute of Child Health and Human Development; Performance; Pharmacologic Substance; Policies; Procedures; Program Development; Protocols documentation; Quality Control; Recording of previous events; Reporting; Research; Research Personnel; Research Project Grants; Resources; Risk; Safety; Schedule; Site; Specimen; Structure; System; Technology; TimeLine; Training; United States National Institutes of Health; Vendor; Visit; Work; base; experience; human subject protection; meetings; operation; performance site; programs; protocol development; quality assurance; recruit; symposium; tool; web site

ABSTRACT – OPERATIONS AND COLLABORATIONS CENTER (OCC) The primary goal of the Operations and Collaborations Center (OCC) for the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) is to provide overall support for the ATN research program. The ATN OCC will work collaboratively with the ATN Scientific Leadership Center and the Executive Committee (EC) in developing and implementing the ATN scientific agenda through establishing and maintaining the ATN operational infrastructure, providing organizational support, and ensuring site consortium (SC) capacity for the ATN's research projects and with external collaborations. The specific aims for the OCC are: (1) support the ATN infrastructure including facilitate ATN-wide communications, support the EC and formation of subcommittees, schedule and organize routine and ad hoc meetings, including semi-annual Network meetings; and assemble and convene the ATN External Scientific Panel at least annually; (2) train SCs on research- related topics including regulatory, Investigational New Drugs (INDs)/investigational device exemption (IDE), safety reporting, good clinical practice/good clinical laboratory practice, human subjects protection, quality control (QC), and quality assurance procedures; (3) create mechanisms to monitor subject recruitment, retention, and dropout, and develop procedures for adjustment if enrollment targets are not being met; (4) build a detailed system to track and report study progress to the ATN EC and the National Institutes of Health, including a description of performance metrics, milestones, timelines, and QC measures, and strategies to identify and mitigate any issues; (5) liaison with the ATN EC to produce and maintain a Network Manual of General Operations, including standard operating procedures and policies; (6) provide and lead full regulatory structure to support all ATN and cross-network investigational (IND/IDE) clinical trials; (7) Maintain the ATN protocol disbursement fund and execute all necessary agreements to support site-specific subject accrual visit reimbursement, reconciling reimbursement with site performance, recruitment, and retention; (8) manage ATN resources and execution of performance-based subcontractors such as material distributors, specimen storage, pharmaceutical vendors, investigators; (9) develop and maintain a publicly accessible and restricted website to share information among the ATN and collaborating investigators; (10) establish and support a National Community Advisory Board (CAB) and provide logistical support for all CAB activities and meetings; (11) develop and support cross-network protocols, collaborations, and other projects, including the conduct of trainings and development of manuals of procedures, facilitating communications and conference calls; (12) oversee SCs, and support staffing and structure modifications as necessary to meet the evolving needs of research protocols; and (13) collaborate fully and with transparency, including appropriate sharing of all necessary tools, materials, technologies and other essential methodologies necessary for protocol and program development, implementation, and monitoring across the Network and with other networks.

摘要-运营和协作中心(OCC) 青少年医学试验的操作和协作中心(OCC)的主要目标 艾滋病毒/艾滋病干预网络(ATN)将为ATN研究计划提供全面支持。这个 ATN OCC将与ATN科学领导中心和执行委员会合作 (欧共体)通过建立和维持ATN，制定和实施ATN科学议程 运营基础设施，提供组织支持，并确保现场联合体(SC)能力 ATN的研究项目以及与外部合作。协调中心的具体目标是：(1)支持 ATN基础设施包括促进ATN范围内的通信，支持EC和形成 小组委员会安排和组织例行和临时会议，包括每半年举行一次的网络会议； 并至少每年召集和召集ATN外部科学小组；(2)对SC进行研究培训- 相关主题包括监管、研究用新药(IND)/研究用具豁免(IDE)、 安全报告、良好的临床实践/良好的临床实验室实践、人类受试者保护、质量 控制(QC)和质量保证程序；(3)建立监测受试者招募的机制， 保留和退学，并制定程序，以便在未达到招生目标时进行调整； 向ATN EC和国家卫生研究院跟踪和报告研究进展的详细系统， 包括对绩效指标、里程碑、时间表和质量控制措施的描述，以及 识别和缓解任何问题；(5)与ATN EC联络，编制和维护以下网络手册： 一般业务，包括标准操作程序和政策；(6)提供和领导全面监管 支持所有ATN和跨网络研究(IND/IDE)临床试验的结构；(7)维护ATN 礼宾支付资金和执行所有必要的协议，以支持特定地点的主题应计访问 报销，使报销与现场绩效、招聘和保留保持一致；(8)管理ATN 材料分销商、样品等基于绩效的分包商的资源和执行 存储、药品供应商、调查人员；(9)开发和维护公众可访问和受限的 在ATN和合作调查人员之间共享信息的网站；(10)建立和支持 国家社区咨询委员会(社区咨询委员会)并为社区咨询委员会的所有活动和会议提供后勤支助； (11)开发和支持跨网络协议、协作和其他项目，包括开展 培训和编写程序手册，促进通信和电话会议；(12) 监督供应链，并在必要时支持人员编制和结构修改，以满足不断变化的需求 研究方案；和(13)充分和透明地合作，包括适当分享所有 必要的工具、材料、技术和其他必要的方法 整个网络以及与其他网络之间的计划开发、实施和监控。