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Data Core



The ADCS Data Core is responsible for the day-to-day operations of all ADCS clinical studies from inception through final data analysis. The Data Core is comprised of the following groups: Data Entry, Quality Control, Data Systems, and Biostatistics. Data entry, data reporting, subject approval, randomization, quality control, analysis, and study tracking are implemented using the automated web based system connected to a central data base. All Project Director and ADCS Coordinating Center staff has remote online access to a private intranet customized for each protocol. The Data Core provides support for each protocol including working with the Project Director and ADCS Principal Investigator on protocol development and finalization, organizing and coordinating each protocol training meeting, generation of case report forms, ongoing training of new site staff, data collection and quality control, and study tracking. Online reports are continually available for viewing by Project Directors and Coordinating Center staff using a web browser to track the progress of study enrollment and ongoing study visits from site to site. The staff manages data collection and quality control online. Data are entered electronically into the online system using the web interface via online electronic forms with embedded real time data checking algorithms to provide immediate quality feedback.