Clinical Core Stephanie S. O’Malley, Ph.D. Abstract The Clinical Core serves an important function as the central resource for the diverse CTNA projects and pilots. The opportunity to fund a central core with a distinguished leader provides a programmatic method to define needs and assign resources to address central issues. The central components of the Clinical Core are oversight of subject recruitment, participant safety and clinical assessments in human studies, and data management and biostatistical support for all Center projects. The Core also oversees the creation of a cross- project “Core Database” for investigating phenotypes relevant to the CTNA and its mission. The specific aims for this core are: A. Centralized monitoring and recruitment of subjects to: 1) Enhance the efficiency of enrollment into each project, including pilots; 2) Ensure the safety of participants and 3) Update the Principal Investigators (PIs), the Steering Committee, the Program Advisory Committee, and the Data Safety Monitoring Board of progress on the protocols. B. Central oversight of assessments to: 1) Provide efficiency in training and assessment; 2) Maintain consistency in the administration of assessments; 3) Enhance the ability of investigators to pool data across studies; 4) Ensure that validated and current assessment tools are used; and 5) Support secondary analyses utilizing core assessments from the Core database. C. Central provision of data management and biostatistics support to: 1) Provide design and analytical expertise to meet the goals of the CTNA scientific agenda; 2) Provide state-of-the-science methods for data management; 3) Generate randomization lists and assess randomization implementation; 4) Interface with specialized data analysis expertise related to particular technologies associated with the CTNA, including genetics and imaging; 5) Prepare reports related to the progress of clinical studies for the Data Safety Monitoring Board, FDA and NIH; 6) Provide statistical support for all investigators; and 7) Create data structure and uploads required for the provision of data to the NIAAA Data Archive.