Data Coordinating 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 采集和分析核心(DAAC)将监督科学标准和方法的一致使用 严谨的数据采集、处理和分析能力。行政核心，与联邦政府协调 该合作协议中的合作伙伴将监督站点的运营，数据协调核心(DCC)， 以及DAAC，以确保在方法和伦理上严格、高效地完成科学目标。DCC 将利用信息学和技术来开发、维护和监控可靠、安全、符合HIPAA标准的数据 收集、协调和存储系统，以简化整个 并确保有组织、安全的数据管理、质量控制和可靠的上载到国家 自闭症研究数据库和NIH/NIMH数据仓库。DCC受益于耶鲁大学中心 临床调查的数据协调和质量保证经验。DCC将：1)预期、响应 在设计、协调和实施数据方面满足联合体的信息学需求 跨财团组成部分和研究的协调和创新数据收集方法和工具 收集和管理EEG、ET和临床措施；2)提供最先进的方法支持 这些研究涉及：a)联合体通信；b)数据管理、站点监测、隐私和安全 在财团内部和跨地点；(C)向利益攸关方传播信息。

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 Acquisition and Analysis Core (DAAC) will oversee consistent use of scientific standards and methodological rigor for data acquisition, processing, and analytics. The Administrative Core, in coordination with federal partners in this cooperative agreement, will oversee the operations of the sites, Data Coordinating Core (DCC), and DAAC to ensure methodologically and ethically rigorous, efficient completion of scientific aims. The DCC will utilize informatics and technology to develop, maintain, and monitor a robust, secure, HIPAA-compliant data collection, coordination, and storage system to streamline communication and data flow throughout the consortium and ensure organized, secure data management, quality control, and reliable upload to the National Database for Autism Research and NIH/NIMH Data Repositories. The DCC benefits from the Yale Center for Clinical Investigation’s data coordinating and quality assurance experience. The DCC will: 1) anticipate, respond to, and fulfill the informatics needs of the consortium in the design, harmonization, and implementation of data coordination and innovative data collection methods and tools across consortium components and studies for collection and management of EEG, ET, and clinical measures; 2) provide state-of-the-art methods in support of these studies for: a) consortium communication; b) data management, site monitoring, privacy, and security within the consortium and across sites; and c) the dissemination of information to stakeholders.