Data Coordinating Core

项目概要/摘要 该联盟的目标是建立可用作生物标志物和/或敏感可靠的工具 自闭症谱系障碍（ASD）临床试验中社会损害的客观分析。具体而言，我们的目标是 通过验证结果指标，加速ASD社交障碍的有效治疗方法的开发 这将是对治疗反应、EEG和眼动追踪（ET）的敏感和可靠评估 可用于通过分层降低样品异质性的生物标志物，指示早期疗效，和/或 显示目标已锁定该联盟将进行一项自然主义的，纵向研究学前（3-5 患有ASD和典型发育（TD）的学龄（6-11岁）儿童，智商范围为50- 115.将由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， 护理人员和基于实验室（LB）的社交障碍测量，沿着一系列概念相关的EEG 以及ET任务和临床状态的独立评级。这个电池测量社会的关键方面- ASD中的沟通使用经过验证的范例适合于这个发展和认知范围。 五个协作实施中心（“中心”），均在多中心协作临床方面经验丰富 在典型和非典型开发中使用本文提出的方法进行研究，将同样有助于 招募、筛选、诊断、测试和纵向评估。数据采集和分析 核心（DAAC）将监督科学标准的一致应用和标准化方法的严格性。 数据收集、处理和分析。管理核心将监督网站的运营， 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 这一合作协议的目的。它将利用信息学和技术来开发、维护和监测 一个强大、安全、符合HIPAA标准的数据收集、协调和存储系统， 通信和数据流在整个财团，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 储存库。DCC受益于耶鲁临床研究中心的质量保证经验 和现有的多站点ASD研究数据系统由普罗米修斯研究开发。DCC将：1） 预测、响应和满足联合体在设计、协调和 在各研究中心、DAAC、 和管理核心; 2）提供最先进的方法：a）联盟通信; B）数据管理， 联合体内部和跨站点的站点监控、隐私和安全;以及c）信息传播 向其利益相关者。

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.