Data Coordinating Core

项目总结/摘要 自闭症生物标志物临床试验联盟（ABC-CT）的持续目标是建立 脑电描记术（EEG）和眼动追踪（ET）生物标志物，其可用于分层和/或作为脑电描记术（EEG）和眼动追踪（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测定。 这一延期申请旨在通过三项研究进一步验证有希望的措施， 增强和扩展原始ABC-CT研究：（1）在新队列中对原始发现进行确认研究 使用相似设计（T1：基线，T2：基线后6周，T3：基线后24周）和样本 大小/特征（200例ASD，200例典型发育（TD））;（2）原始队列的随访研究 （N=399）在初始ABC-CT入组后2.5-4年重新给予生物标志物和临床组合;（3）a 在学龄前（3-5岁）儿童（25名ASD，25名 TD）。生物标志物和临床电池测量ASD中社交沟通的关键方面， 适用于预期发展和认知范围的验证范式。这项研究将依赖于 相同的领导层和第一阶段的五个协作实施站点（“站点”），所有站点都经验丰富 在多站点协作临床研究中使用所提出的临床、EEG和ET方法。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 数据采集、处理和分析的严格性。行政核心，与联邦协调 本合作协议中的合作伙伴，将监督网站的运营，数据协调核心（DCC）， 和DAAC，以确保在方法和道德上严格，有效地完成科学目标。的DCC 将利用信息学和技术来开发、维护和监控一个健壮、安全、符合HIPAA标准的数据 收集、协调和存储系统，以简化整个 联盟，并确保有组织的，安全的数据管理，质量控制，并可靠地上传到国家 自闭症研究数据库和NIH/NIMH数据库。DCC受益于耶鲁中心， 临床研究的数据协调和质量保证经验。DCC将：1）预测，响应 满足联合体在数据设计、协调和实施方面的信息学需求 协作体各组成部分和研究之间的协调和创新的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， 这些研究用于：a）联合体通信; B）数据管理、现场监控、隐私和安全 在联合体内部和跨站点;以及c）向利益相关者传播信息。

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.