Data Coordinating Core

项目摘要/摘要 该联盟的目标是建立可用作生物标志物和/或敏感和可靠的工具 目的研究自闭症谱系障碍(ASD)临床试验中的社会功能障碍。具体来说，我们的目标是 通过验证结果指标，加速开发ASD社会功能障碍的有效治疗方法 这将是对治疗、脑电和眼球跟踪(ET)反应的敏感和可靠的评估。 生物标志物，可用于通过分层降低样品的异质性，指示早期疗效，和/或 展示目标参与度。该联盟将对学龄前儿童(3-5岁)进行一项自然主义的纵向研究 年)和学龄儿童(6-11岁)患有自闭症和典型发育(TD)的儿童，智商从50- 115.将使用临床医生在三个时间点(T1：基线、T2：6周、T3：24周)对儿童进行评估， 照顾者和基于实验室的(LB)社会损害测量，以及一组概念上相关的脑电 ET任务和临床状态的独立评分。这一电池衡量了社交的关键方面- 在自闭症中使用适合于这种发育和认知范围的经过充分验证的范例进行沟通。 五个协作实施站点(“站点”)，均在多站点协作临床方面经验丰富 在典型开发和非典型开发中使用这里提出的方法进行的研究将做出同样的贡献 到招募、筛选、诊断、测试和纵向评估。数据采集与分析 核心(DAAC)将监督标准化的科学标准和方法的严格一致的应用 数据收集、处理和分析。行政核心将监督网站的运作， 数据协调核心(DCC)和DAAC，并与联邦和私人合作伙伴协调以实现 这项合作协议的目的。将利用信息学和技术来开发、维护和监控 强大、安全、符合HIPAA的数据收集、协调和存储系统，可简化 通信和数据在整个联合体中流动，并确保有组织、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 储存库。DCC受益于耶鲁临床调查中心的质量保证经验 以及普罗米修斯研究公司开发的现有多站点ASD研究数据系统。DCC将：1) 预测、响应并满足联合体在设计、协调和 在各站点实施数据协调和创新的数据收集方法和工具， 和管理核心；2)提供最先进的方法：a)联盟通信；b)数据管理， 联合体内和跨站点的站点监测、隐私和安全；以及c)信息传播 给它的利益相关者。

Project Summary/Abstract The goal of this consortium is to establish tools that can be used as biomarkers and/or sensitive and reliable objective assays of social impairment in autism spectrum disorder (ASD) clinical trials. Specifically, we aim to accelerate the development of effective treatments for social impairment in ASD by validating outcome measures that will be sensitive and reliable assessments of response to treatment and EEG and eye-tracking (ET) biomarkers that can be used to reduce heterogeneity of samples via stratification, indicate early efficacy, and/or demonstrate target engagement. The consortium will conduct a naturalistic, longitudinal study of preschool (3-5 years) and school aged (6-11 years) children with ASD and typical development (TD) with IQ ranging from 50- 115. Children will be assessed across three time points (T1: Baseline, T2: 6 weeks, T3: 24 weeks) using clinician, caregiver and lab-based (LB) measures of social impairment, along with a battery of conceptually related EEG and ET tasks and independent ratings of clinical status. This battery measures key facets of social- communication in ASD using well-validated paradigms appropriate for this developmental and cognitive range. Five Collaborating Implementation Sites (“Sites”), all highly experienced in multi-site collaborative clinical research using the methodologies proposed here in both typical and atypical development, will contribute equally to recruitment, screening, diagnosis, testing, and longitudinal assessment. The Data Acquisition and Analysis Core (DAAC) will oversee consistent application of scientific standards and methodological rigor for standardized data collection, processing, and analytics. The Administrative Core will oversee the operations of the Sites, the Data Coordinating Core (DCC), and the DAAC and coordinate with federal and private partners to achieve the aims of this cooperative agreement. The 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 quality assurance experience and the existing multi-site ASD research data systems developed by Prometheus Research. 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 the Sites, DAAC, and Admin Core; 2) Provide state-of-the-art methods for: a) consortium communication; b) data management, site monitoring, privacy, and security within the consortium and across Sites; and c) dissemination of information to its stakeholders.