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 – 运营与合作中心 (OCC) 青少年医学试验运营与合作中心 (OCC) 的主要目标 HIV/AIDS干预网络（ATN）将为ATN研究项目提供全面支持。 ATN OCC 将与 ATN 科学领导中心和执行委员会合作 (EC) 通过建立和维护 ATN 来制定和实施 ATN 科学议程 运营基础设施，提供组织支持，并确保站点联盟 (SC) 的能力 ATN 的研究项目以及与 OCC 的外部合作的具体目标是： (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，包括半年一次的网络会议； 至少每年召集并召开 ATN 外部科学小组会议； (2) 对 SC 进行研究培训； 相关主题包括监管、研究性新药 (IND)/研究性器械豁免 (IDE)、 安全报告、良好临床实践/良好临床实验室实践、人体受试者保护、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， (4) 建立保留和退学制度，并制定未达到入学目标时的调整程序； 用于跟踪并向 ATN EC 和国立卫生研究院报告研究进展的详细系统， 包括绩效指标、里程碑、时间表和质量控制措施的描述以及策略 (5) 与ATN EC联络以制作和维护网络手册 一般运营，包括标准运营程序和政策；(6) 提供并领导全面监管； (7) 维护ATN 协议支付基金并执行所有必要的协议，以支持特定地点的主题应计访问 (8) 管理ATN 基于绩效的分包商（例如材料分销商、样品）的资源和执行 (9) 开发和维护可公开访问且受限制的 在 ATN 和合作调查人员之间共享信息的网站； (10) 建立并支持 国家社区咨询委员会 (CAB) 并为所有 CAB 活动和会议提供后勤支持； (11) 开发和支持跨网络协议、协作和其他项目，包括开展 (12) 培训和制定程序手册，促进沟通和电话会议； 监督 SC，并根据需要支持人员配置和结构修改，以满足不断变化的需求 研究方案；(13) 充分、透明地合作，包括适当共享所有信息 协议和协议所需的必要工具、材料、技术和其他基本方法 整个网络以及与其他网络的计划开发、实施和监控。