The Clinical Operations Core serves a critical role in coordinating the day-to-day operations of the protocols. The Clinical Operations Core is divided into two main components: 1. Project Management - This team of Project Managers and Coordinators lead all of the day-to-day management of the conduct of the protocol including protocol and procedures development, timeline management, training, and study milestones during start-up, enrollment, maintenance, and close-out. 2. Process and Data Management - This team of Data Management and other support staff leads the effort related to standardization of Clinical Operations Core procedures, providing reliable and consistent support to the study-team at sites and the ADCS, as well as oversight and implementation of protocol specific Data Management activities. In particular the Data Management team focuses on eCRF design and development within the ADCS EDC system, responsibility for data quality controls, and study progress reporting.
The Clinical Operations Core was integrally involved in all aspects ofthe performance of these protocols, including development of protocols and procedures, training and support of sites, coordination of day-to-day operations, and data management. During the current grant cycle, seven protocols initiated during previous grant cycles were carried to completion.
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