Harmonizing Protocol Complexity with Resource Management and Capacity Planning at Clinical Research Sites
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ORIGINAL ARTICLE
Harmonizing Protocol Complexity with Resource Management and Capacity Planning at Clinical Research Sites David J. Morin1,2 Received: 2 August 2019 / Accepted: 3 January 2020 © The Drug Information Association, Inc 2020
Abstract Background Clinical research sites conduct trials with diverse complexities, timelines, and ever-changing workloads. Though the principal investigator (PI) is ultimately responsible for the content and conduct of trials, they rely heavily on site staff to successfully enroll and complete studies following good clinical practice (GCP) Guidelines. The mainstays of the site workforce are the clinical research coordinators (CRCs) to whom the trials are assigned. These CRCs work on many studies concurrently. Managing study assignments and workload is a difficult task that requires knowledge of the trial complexity, expected enrollment, and many other factors affecting performance. Methods Traditional methods for allocating workload to site staff quantitate trial complexity and estimate work hours by factoring in the number of trial participants. However, this does not account for the effects of associated workload or variability in staff attributes. It also neglects other factors that affect performance and assumes maximum enrollment and completion of the trial by all participants. This article introduces a novel approach that determines the effects of protocol complexity on CRC productivity without effort tracking. These metrics permit an assessment of how the CRC’s performance is affected by the number of studies assigned. Results By understanding the effects of workload allocation on CRC productivity and capacity, the site manager can use an algorithmic approach toward improving performance. The process takes into account factors that are both within and outside the control of the site manager. Conclusion Sites may benefit from analytics that measures how CRCs adapt to the effects of study complexity on cumulative workloads over time. Optimizing productivity also means conforming to GCP Guidelines and avoiding staff burnout. As studies become increasingly difficult, site managers need tools to manage complexity and balance workloads among staff. Keywords Complexity · Workload · Capacity · Productivity · Resources
Introduction
Some discussion points in this article were presented at the following: Interactive Response Technologies (IRT), October 2018, Philadelphia, PA; SCOPE Summit, February 2019, Orlando, FL; and MAGI East Clinical Research Conference, May 2019, Boston. MA. This article was written between December 2018 and July 2019. Thanks to Beth Harper BS, MBA for her review of the manuscript, and Sheila P. Smith, Ed.D. for her editorial suggestions. * David J. Morin [email protected] 1
Trike®, LLC, 1751 Holston Drive, Bristol, TN 37620, USA
Holston Medical Group, 105 W. Stone Drive, Suite 3B, Kingsport, TN 37660, USA
2
Resource management and capacity planning (RM&CP) is a process that determines the research site’s existing and nearfuture abi
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