Core--Protocol Management and Coordination of Multi-center Trials

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The services provided by the Protocol Management and Coordination of Multi-Center Trials Core, are multifaceted. First, the Core will provide the mechanism for the regulatory management of protocols including the process for IRB approval. Second, it will determine patient eligibility and registration to protocols. Third, it will facilitate protocol implementation including the coordination of protocol-specific patient workups, research specimen collections, and adverse event reporting on a real time basis. Fourth, it will coordinate clinical data collection that is protocol-specific. Finally, it will serve as the data coordination center for the multi-center trials proposed. Multi-center studies are critical for the studies proposed in these projects because the planned transplantation protocols address relatively uncommon diseases. Accrual of patients in these disease categories to any one center is likely to be limited, and more rapid accrual can be achieved through multi-center collaboration. Such collaborations require coordination of data collection, feedback to participating institutions, and multi-center assurances of IRB requirements. This Core will provide resources to obtain outcome data for analysis of these trials. The role of this Core is to coordinate and gather data from the collaborative network outside of Seattle, and to integrate data from the central patient database maintained by Clinical Statistics with data collected solely for the multi-center studies. The Long-Term Follow-Up (LTFU) department provides follow-up on all Seattle patients transplanted under the auspices of this grant, and, where appropriate, these data are then integrated into the multi-center database. This Core is also responsible for coordinating the acquisition of research samples for the Immune Function Studies Core.