Abstract
The impact of the structure and organization of clinical research services (data management model) on the workload of clinical research coordinators (CRCs) at investigative sites is undocumented. This paper describes three types of data management models and their potential influence on the workload of CRCs. A 20-item survey, covering information about accrual to clinical trials, staffing levels, use of workload measurement tools, and the data management model, was e-mailed to nine CRCs working at selected cancer centers in the United States.
Six CRCs representing four university-based institutions and two community hospitals responded. Staffing levels and number of patients placed on clinical trials varied by institution and data management model. One out of six centers used a workload formula based upon the time it takes to complete a task. The centralized clinical data management model and the modified/mixed models were common. Our findings suggest that it is important to understand the structure of the clinical data management model, among other factors, in evaluating the workload of CRCs.
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