Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)

The Alzheimer’s Therapeutic Research Institute acts as the Clinical Coordinating Center and the Clinical Core for the ADNI project. In this capacity, the ATRI provides administrative and operational support through its Cores at USC. The Administrative Core provides the overall administration of the Coordinating Center. The main areas of responsibility of the Administrative Core are the recruitment and retention of subjects, establishment and maintenance of subcontracts with the sites, tracking visit activities and providing payments for the subcontracts, human subject’s regulatory compliance and consent form development, planning and coordination of the training and steering committee meetings, and supporting communications. The Medical Core is responsible for the clinical site monitors and interaction with the Data and Safety Monitoring Board (DSMB), and processing clinical and adverse event data. The Clinical Operations Core is responsible for developing, updating and distributing study documents (protocols, training and procedures manuals), coordinating and organizing the clinical trial activities at the sites, tracking enrollment and assigning open enrollment slots, managing and distributing study supplies, acting as the primary point of contact for the sites, and coordinating clinical operations activities. The Informatics Core, working closely with Clinical Operations, is responsible for developing and maintaining the data collection system as well as providing data management support, including the generation and maintenance of electronic case report forms, development and implementation of quality control procedures, data collection and study tracking.