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

Fred Hutchinson Cancer Research Center, Seattle WA

Investigators

Linked publications & trials

Abstract

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