Administrative Core

项目摘要/摘要 自闭症临床试验生物标记物联盟(ABC-CT)的持续目标是建立 可用于分层和/或AS的脑电(EEG)和眼球跟踪(ET)生物标志物 在自闭症谱系障碍(ASD)临床试验中，与社会功能相关的敏感和可靠的客观分析。 这份续签申请旨在通过三项研究进一步验证有前景的措施 加强和扩展最初的ABC-CT研究：(1)对新队列中最初发现的确证研究 使用类似的设计(T1：基线，T2：基线后6周，T3：基线后24周)和样本 大小/特征(200人患有自闭症，200人有典型发育(TD))；(2)对原始队列的后续研究 (n=399)在最初的ABC-CT登记后2.5-4年重新管理生物标志物和临床电池；(3)a 学龄前(3-5岁)儿童(25例ASD，25例)并行EEG和ET生物标志物的可行性研究 与TD)。生物标记物和临床电池使用Well-MARKER来测量ASD中社交沟通的关键方面 经过验证的范例适合预期的发展和认知范围。这项研究将依靠 相同的领导力和第一阶段的五个协作实施站点(“站点”)，均经验丰富 在使用建议的临床、EEG和ET方法的多地点协作临床研究中。数据 协调核心(DCC)将为通信和数据集成提供安全的信息基础设施 整个联合体确保有组织的数据管理、质量控制和可靠的上载到National 自闭症研究数据库(NDAR)和美国国立卫生研究院数据库。数据采集与分析核心 (DAAC)将监督数据收集的科学标准和方法严格性的一致使用， 处理和分析。行政核心将监督站点、DCC和 助理署长确保在方法和道德上严谨、有效率地完成研究目标，并协调 通过以下方式与联邦合作伙伴签订合作协议：1)协调通信和数据共享，以 管理项目的所有方面，包括征聘和数据收集、数据管理和质量 控制、数据采集和处理的标准化、分析规划和财务管理；2) 在管理中央机构方面，跨所有地点和核心管理联合体项目 评审委员会，制定和传播标准操作程序，实施良好临床 实践，保持研究的保真度，监督质量控制，并计划及时上传到NIH/NIMH数据 存储库；3)保持适当的沟通并整合联邦合作伙伴的反馈， 根据合作协议执行最后敲定的议定书，并规划指导委员会会议 以及一年一度的面对面会议。

Project Summary/Abstract The ongoing goal of the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is to establish electroencephalography (EEG) and eye-tracking (ET) biomarkers that can be used for stratification and/or as sensitive and reliable objective assays related to social function in autism spectrum disorder (ASD) clinical trials. This renewal application seeks to further validate promising measures through three studies designed to enhance and extend the original ABC-CT study: (1) a confirmation study of the original findings in a new cohort using similar design (T1: Baseline, T2: 6 weeks post baseline, T3: 24 weeks post baseline) and sample size/characteristics (200 with ASD, 200 with typical development (TD)); (2) a follow-up study of the original cohort (N=399) to re-administer the biomarker and clinical batteries 2.5-4 years after original ABC-CT enrollment; (3) a feasibility study of parallel EEG and ET biomarkers in preschool-aged (3-5-year-old) children (25 with ASD, 25 with TD). The biomarker and clinical batteries measure key facets of social-communication in ASD using well- validated paradigms appropriate for the intended developmental and cognitive range. The study will rely on the same leadership and five Collaborating Implementation Sites (“Sites”) from the first phase, all highly experienced in multi-site collaborative clinical research using the proposed clinical, EEG, and ET methodologies. The Data Coordinating Core (DCC) will provide a secure informatics infrastructure for communication and data integration across the consortium to ensure organized data management, quality control, and reliable upload to the National Database for Autism Research (NDAR) and NIH Data Repositories. The Data Acquisition and Analysis Core (DAAC) will oversee consistent use of scientific standards and methodological rigor for data acquisition, processing, and analytics. The Administrative Core will oversee the operations of the sites, the DCC, and the DAAC to ensure methodologically and ethically rigorous, efficient completion of study aims and to coordinate with federal partners in this cooperative agreement by: 1) Coordinating communication and data sharing to manage all aspects of the project, including recruitment and data collection, data management and quality control, standardization of data acquisition and processing, analytic planning, and financial management; 2) Administering the consortium project across all sites and cores in terms of managing the central institutional review board, developing and disseminating Standard Operating Procedures, implementing Good Clinical Practice, maintaining research fidelity, overseeing quality control, and planning timely upload to NIH/NIMH Data Repositories; 3) Maintaining appropriate communication and integrating feedback from federal partners, executing the finalized protocol as per the collaborative agreement, and planning Steering Committee meetings and annual in-person meetings.