Organization of Clinical Research Services at Investigative Sites: Implications for Workload Measurement
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ORGANIZATION OF CLINICAL RESEARCH SERVICES AT INVESTIGATIVE SITES: IMPLICATIONS FOR WORKLOAD MEASUREMENT CLEMENTGWEDE,RN, MPH Radiation Oncology Research Coordinator, Interdisciplinary Oncology Program, Clinical Research and Compliance Services
STEPHANIE DANIELS,FW,CCRC ECOG Clinical Trials Coordinator, Clinical Research and Compliance Services
DARLENEJOHNSON, MBA, CCRP Administrator, Radiation Oncology Program Moffitt Cancer Center & Research Institute, Tampa, Florida
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, staflng 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 representingfour university-based institutions and two community hospitals responded. StafJig 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 managemenr model and the modifiedhixed 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. Key Words: Clinical research coordinators; Clinical research; Clinical research data management services; Data management models; Workload measurement
INTRODUCTION QUANTINING (volume’ time) and financial resources needed for conducting clinical trials is a challenging priority
Reprint address: Clement Gwede, Moffitt Cancer Center & Research Institute, Radiation Oncology Program, ~ 12902 ~ ~~ , . i T ~ ~ , ~ ~ 33612, l ~ ~ - ~, i & [email protected].
for clinical research coordinators, investigators, and research administrators at investigative sites, as well as study sponsors. There is a lack of practical, meaningful, and reliable measures that can be readily applied to determine staffing needs for the conduct of clinical trials (1,2).Tremendous diversity in roles and responsibilities of research coordinators, in institutional structure and orl differences : ~ ganization of clinical research data manage-
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Clement Gwede, Stephanie Daniels, and Darlene Johnson
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ment operations (data management model), variability in staff mix and experience, differences in institutional mindset, and commitment to clinical research all hinder the development of a universal tool for workload measurement. The ideal tool should meet among others, the following criteria: 1. Be simple to use, 2. Be flexible across disease p
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