AUTHOR=Webb Sara Jane , Shic Frederick , Murias Michael , Sugar Catherine A. , Naples Adam J. , Barney Erin , Borland Heather , Hellemann Gerhard , Johnson Scott , Kim Minah , Levin April R. , Sabatos-DeVito Maura , Santhosh Megha , Senturk Damla , Dziura James , Bernier Raphael A. , Chawarska Katarzyna , Dawson Geraldine , Faja Susan , Jeste Shafali , McPartland James , the Autism Biomarkers Consortium for Clinical Trials , Atyabi Adham , Aubertine Madeline , Carlos Carter , Chang Shou-An A , Compton Scott , Dommer Kelsey , Gateman Alyssa , Hasselmo Simone , Heit Bailey , Howell Toni , Harris Ann , Hutchins Kathryn , Holub Julie , Li Beibin , Major Samantha , Marsan Samuel , McAllister Takumi , Leal Andriana S. Méndez , Nanamaker Lisa , Nelson Charles A. , Seow Helen , Stahl Dylan , Yuan Andrew TITLE=Biomarker Acquisition and Quality Control for Multi-Site Studies: The Autism Biomarkers Consortium for Clinical Trials JOURNAL=Frontiers in Integrative Neuroscience VOLUME=13 YEAR=2020 URL=https://www.frontiersin.org/journals/integrative-neuroscience/articles/10.3389/fnint.2019.00071 DOI=10.3389/fnint.2019.00071 ISSN=1662-5145 ABSTRACT=

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.