SDMC; Statistical Data Mgmt Core

项目摘要 作为一个成熟的研究网络，ATN已经准备好聚集创新和经验丰富的学者， 提供者和社区合作伙伴能够提供正确的预防和治疗技术， 在正确的时间和地点为那些最能受益的人提供组合。强大的统计和数据 管理核心（SDMC）是成功规划、实施、分析、传播和 所有ATN研究项目的管理，跨网络分析，并对青少年领域的贡献 以及年轻人的艾滋病毒预防和护理。为了在ATN融资周期中提供SDMC服务，我们 来自北卡罗来纳州、埃姆斯和哈佛大学/马萨诸塞州的领导团队。的 SDMC将为所有网络临床研究提供全面的数据管理和分析; 以及监管、生物统计、研究设计、分析、解释和结果发表方面的服务。 SDMC将使用创新的统计方法和最先进的临床试验管理系统， 实验室信息管理系统，以确保完整，高质量的数据。SDMC领导人一致 致力于通过卓越的循证干预措施改善艾滋病毒预防和护理成果 research.我们的核心将提供科学和分析专业知识，全面的数据管理和数据 管理资源，协调和监督ATN及其个人和跨网络 协议，以及更广泛的科学和ATN利益相关者社区。SDMC负责 研究设计的完整性、数据管理的质量以及所有临床分析的严谨性和重现性 本申请中提出的研究和本ATN项目周期内未来出现的科学优先事项。我们 将确保所有ATN研究符合机构伦理审查规定的数据访问和安全协议 要求、联邦监管标准和适用的国际指南。此外，SDMC将 在ATN内部和按照 与其他NIH赞助的项目。在单个研究的整个生命周期内，SDMC将协调 临床和实验室数据收集和管理所需的服务和系统， 研究项目和整个ATN研究议程。在这些活动中，SDMC将有意 通过指导和参与，促进更公平地使用、获取和传播数据 学员、早期调查人员和少数族裔在SDMC活动中的代表性不足。我们组建了一个 多元化的团队，具有互补的领导经验和统计分析，流行病学， 艾滋病毒，统计建模和成本分析，青少年和年轻成人艾滋病毒干预发展， 评估，循证临床护理，网络科学和多站点，多研究生物医学和行为 临床试验我们的SDMC领导模式和集体专业知识将提供高质量的研究设计， 数据系统和管理，以及数据管理，以产生有影响力的科学来减少青少年艾滋病毒。

PROJECT SUMMARY As a mature research network, the ATN is well-poised to assemble innovative and experienced scholars, providers and community partners that can deliver prevention and treatment technologies in the right combinations at the right time and place for those who could benefit most. A strong Statistical and Data Management Core (SDMC) is central to the successful planning, implementation, analysis, dissemination, and stewardship of all ATN research projects, cross-network analyses, and contributions to the field of adolescent and young adult HIV prevention and care. To provide SDMC services for this ATN funding cycle, we assembled a leadership team from the University of North Carolina, Emmes, and Harvard University/Mass General. The SDMC will provide comprehensive data management and analyses for all network clinical studies; leadership; and services for regulatory aspects, biostatistics, study design, analysis, interpretation, and publication of results. The SDMC will use innovative statistical methods and state-of-the-art clinical trial management systems and laboratory information management systems to ensure complete, high-quality data. SDMC leaders are uniformly committed to improving HIV prevention and care outcomes through excellence in evidence-based interventional research. Our Core will provide scientific and analytic expertise, comprehensive data management and data stewardship resources, and coordination, and supervision to the ATN and its individual and cross-network protocols, as well as to the broader scientific and ATN stakeholder communities. The SDMC is responsible for the integrity of study design, quality of data management and rigor and reproducibility of analyses for all clinical studies proposed in this application and future emerging scientific priorities during this ATN project cycle. We will ensure that all ATN studies meet data access and security protocols defined by institutional ethical review requirements, federal regulatory standards, and applicable international guidelines. In addition, the SDMC will lead efforts to standardize and harmonize data management and statistical activities within the ATN and in line with other NIH-sponsored programs. Throughout the lifetime of an individual study, the SDMC will coordinate services and systems for the clinical and laboratory data collection and management required to support the research projects and the overall ATN research agenda. Across these activities, the SDMC will intentionally promote more equitable use, accessibility, and dissemination of data through mentorship and involvement of trainees, early-stage investigators, and under-represented minorities in SDMC activities. We have assembled a diverse team with complementary leadership experience and expertise in statistical analyses, epidemiology of HIV, statistical modeling and cost analysis, adolescent and young adult HIV intervention development and evaluation, evidence-based clinical care, network science and multi-site, multi-study biomedical and behavioral clinical trials. Our SDMC leadership model and collective expertise will provide the high-quality study design, data systems and management, and data stewardship to generate impactful science to reduce adolescent HIV.