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Use of Proxy Variables to Determine the Impact of Protocol Complexity on Clinical Research Site Productivity.

Morin, David J.
Ther Innov Regul Sci; : 2168479018769290, 2018 Jan 01.
Artigo em Inglês | MEDLINE | Maio 2018 | ID: mdl-29714592
Resumo: BACKGROUND: Research coordinators (or teams) are usually assigned to multiple studies of varying complexity at any one time, each with different and ever-changing workloads. As a result, determining the impact of protocol complexity on productivity is not easily accomplished. Standard methods of effort tracking typically require oversight or create additional workload to the site staff under study; they are time-consuming, expensive, intrusive, and usually incomplete. METHODS: This article describes a novel method for determining the impact of protocol complexity on clinical research coordinator (CRC) or team productivity by using proxy variables in place of effort tracking. A protocol assessment tool that quantitates complexity is used to determine cumulative workload. RESULTS: Productivity graphs are generated for each CRC per month and can be followed over time to assess trends or for comparative analysis. CONCLUSION: The data provide managers with unique insights into the functional capacity of study coordinators and support staff. The goal is to optimize efficiency by applying a systematic decision process from performance and productivity trends. In addition to exploring the theory behind the method, this article begins a discussion on the use of this information in clinical research site management.