What is it about?

Historically, measuring productivity at clinical research sites required the use of some form of effort tracking. This article describes a novel way (patent pending) to measure the impact of protocol complexity on performance and productivity without effort tracking by using a protocol scoring tool and accrued revenue as proxies for unpaid workload and output respectively. Since research coordinators (and teams) work on a number of studies at any one time, each with varying complexity and timelines, traditional methods of measuring productivity are not feasible. The method described has been incorporated into software (SiteOptex) to ease the entry of data and the generation of performance and productivity reports. The goal is to provide research site managers with a tool to generate these dynamic metrics in order to guide decisions toward increased productivity.

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Why is it important?

Clinical research sites performance is usually centered around the activity of the study coordinator. Having analytics which allows the site manager to understand the workload capacity of the coordinator, is an important step to avoiding staff burnout and study errors. However, it also provides information to determine if the cause of performance issues are due to improper workload allocation, budget, or intrinsic coordinator failures.

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Without a good understanding of each research coordinators capacity to handle study workload, study managers risk unnecessary staff losses through burnout and study errors. This can place the research volunteer's safety and data validity at risk. Also, as study budgets have not kept pace with rising protocol complexity, studies need to run very efficiently in order to remain financially​ viable.

David Morin
Holston Medical Group

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This page is a summary of: Use of Proxy Variables to Determine the Impact of Protocol Complexity on Clinical Research Site Productivity, Therapeutic Innovation & Regulatory Science, April 2018, SAGE Publications,
DOI: 10.1177/2168479018769290.
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