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

  • Clinical Trials: Original Article
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Abstract

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.

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Authors and Affiliations

  1. Holston Medical Group, Kingsport, TN, USA

    David J. Morin MD, FACP, CPI, FACRP

  2. SiteOptex Software, Trike, LLC, Bristol, TN, USA

    David J. Morin MD, FACP, CPI, FACRP

Authors
  1. David J. Morin MD, FACP, CPI, FACRP
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Corresponding author

Correspondence to David J. Morin MD, FACP, CPI, FACRP.

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Morin, D.J. Use of Proxy Variables to Determine the Impact of Protocol Complexity on Clinical Research Site Productivity. Ther Innov Regul Sci 53, 52–58 (2019). https://doi.org/10.1177/2168479018769290

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  • DOI: https://doi.org/10.1177/2168479018769290

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