The objective of the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is to evaluate a set of lab-based behavioral video tracking (VT), electroencephalography (EEG), and eye tracking (ET) measures for use in clinical trials with children with autism spectrum disorder (ASD). Within the larger organizational structure of the ABC-CT, the Data Acquisition and Analytic Core (DAAC) oversees the standardization of VT, EEG, and ET data acquisition, data processing, and data analysis. This includes designing and documenting data acquisition and analytic protocols and manuals; facilitating site training in acquisition; data acquisition quality control (QC); derivation and validation of dependent variables (DVs); and analytic deliverables including preparation of data for submission to the National Database for Autism Research (NDAR). To oversee consistent application of scientific standards and methodological rigor for data acquisition, processing, and analytics, we developed standard operating procedures that reflect the logistical needs of multi-site research, and the need for well-articulated, transparent processes that can be implemented in future clinical trials. This report details the methodology of the ABC-CT related to acquisition and QC in our Feasibility and Main Study phases. Based on our acquisition metrics from a preplanned interim analysis, we report high levels of acquisition success utilizing VT, EEG, and ET experiments in a relatively large sample of children with ASD and typical development (TD), with data acquired across multiple sites and use of a manualized training and acquisition protocol.

中文翻译：

---

多中心研究的生物标志物采集和质量控制：自闭症生物标志物临床试验联盟。

自闭症生物标志物临床试验联盟 (ABC-CT) 的目标是评估一组用于儿童临床试验的基于实验室的行为视频跟踪 (VT)、脑电图 (EEG) 和眼动跟踪 (ET) 措施患有自闭症谱系障碍（ASD）。在 ABC-CT 更大的组织结构中，数据采集和分析核心 (DAAC) 负责监督 VT、EEG 和 ET 数据采集、数据处理和数据分析的标准化。这包括设计和记录数据采集和分析协议和手册；促进现场采购培训；数据采集​​质量控制（QC）；因变量 (DV) 的推导和验证；和分析可交付成果，包括准备提交给国家自闭症研究数据库 (NDAR) 的数据。为了监督数据采集、处理和分析的科学标准和方法学严谨性的一致应用，我们制定了标准操作程序，以反映多站点研究的后勤需求，以及可以在未来的临床试验。本报告详细介绍了在我们的可行性和主要研究阶段与采集和 QC 相关的 ABC-CT 方法。根据预先计划的中期分析中的采集指标，我们报告了在相对较大的 ASD 和典型发育 (TD) 儿童样本中利用 VT、EEG 和 ET 实验获得高水平的采集成功，数据跨多个站点采集并使用手动训练和获取协议。