Summary
The Clinical Core will provide essential infrastructure and coordination for a research project investigating pathophysiologic mechanisms contributing to cognitive and affective impairments in NPSLE, linking murine model and human subject studies.
What they want
The Clinical Core will coordinate the generation of a single database to identify patient subsets with neurocognitive and behavioral features similar to those in mouse models. It will provide logistical support for human studies, including monitoring subject recruitment (SLE and healthy controls) to ensure enrollment criteria are met. The Core will track and notify investigators of upcoming longitudinal assessments, coordinate biospecimen shipments to appropriate laboratories, and monitor protocol compliance, safety, data integrity, and regulatory compliance in conjunction with the Administrative Core.
Deliverables
- Single database for patient identification
- Coordinated biospecimen shipments
- Monitoring reports for subject recruitment and longitudinal assessments
- Compliance monitoring (protocol, safety, data integrity, regulatory)
Technical requirements
- Database generation and management
- Biospecimen coordination and logistics
