Clinical Core

ABSTRACT – Clinical Core This goals of this research project are to advance our understanding of the pathophysiologic mechanisms contributing to cognitive and affective impairments in NPSLE. The Clinical Core will provide the necessary infrastructure that will be crucial to the interconnectivity of the murine model studies (Project 1) and human subject studies (Project 2). The Clinical Core will coordinate the generation of a single database which will be utilized to identify subsets of patients that have neurocognitive and behavior features similar to those in our mouse models. The Clinical Core will additionally provide logistical support for the human studies, it will monitor subject recruitment (SLE and healthy controls (HC)), ensuring that subjects meet all enrollment criteria. It will monitor progress and track and notify investigators of upcoming assessments for those subjects participating in studies requiring longitudinal assessments. The Core will also coordinate biospecimen shipments to the appropriate laboratories. Importantly, the Clinical Core will monitor protocol compliance, safety, data integrity, and, with the Administrative Core, regulatory compliance.