Page 112 - JCTR-11-5

Journal of Clinical and

Translational Research

SHORT COMMUNICATION
Prospective evaluation of the adapted Ontario

Protocol Assessment Level score for predicting
clinical research coordinator workload: An

internal validation study

1
Kesley Holmes * , Muhammed Idris 1 , Jillian Harvey 2 , Leila Forney 3 ,
Daniel Brinton 2 , Jan Morgan Billingslea 1 , and Priscilla Pemu 1
1 Clinical Research Center, Morehouse School of Medicine, Atlanta, Georgia, United States of
America
2 Department of Healthcare Leadership and Management, College of Health Professions, Medical
University of South Carolina, Charleston, South Carolina, United States of America
3 South Carolina Clinical and Translational Research Institute, College of Medicine, Medical University
of South Carolina, Charleston, South Carolina, United States of America

Abstract

Background: The escalating complexity of clinical trial protocols has considerably
increased the workload for research coordinators, exacerbating staffing shortages
*Corresponding author: and contributing to operational inefficiencies. These challenges are particularly
Kesley Holmes pronounced at under-resourced and minority-serving research institutions, where
(ktyson@msm.edu)
limited capacity may hinder the implementation of trials. Early and accurate estimation
Citation: Holmes K, Idris M, of research coordinator effort is essential for effective planning, resource management,
Harvey J, et al. Prospective
evaluation of the adapted Ontario and successful clinical trial conduct. Aim: This study assesses the accuracy of an
Protocol Assessment Level score adopted Ontario Protocol Assessment Level (OPAL) score in predicting coordinator
for predicting clinical research workload to improve operational planning in clinical research. Methods: A prospective
coordinator workload: An internal
validation study. J Clin Transl Res. observational study was conducted over a 12-month period at a Historically Black
2025;11(5):106-112. College and University medical school. Seven coordinators recorded hours for seven
doi: 10.36922/JCTR025260032 actively enrolling interventional trials. Estimated workloads were calculated using a
Received: June 28, 2025 published, adapted OPAL reference table, and were compared with actual hours using
descriptive statistics and paired t-tests. To ensure consistent benchmarking, workday
Revised: August 12, 2025
equivalencies (7.5 h for institutional standards and 8 h for industry standards) were
Accepted: August 12, 2025 applied. Results: There was no statistically significant difference between estimated
Published online: August 25, 2025 and actual hours, with an average difference of 24.1 h (p=0.761). The mean absolute
error was 167.0 h, equivalent to roughly 1 month of full-time work. Conclusion: The
Copyright: © 2025 Author(s).
This is an open-access article adapted OPAL score provides a practical tool for estimating coordinator workload
distributed under the terms of the and aligning staffing with protocol complexity, including in under-resourced settings.
Creative Commons AttributionNon- However, broader multi-site validation is required to confirm its generalizability and
Commercial 4.0 International (CC
BY-NC 4.0), which permits all to support its integration into feasibility planning. Relevance for patients: Accurate
non-commercial use, distribution, workload forecasting enhances trial efficiency, supporting timely, high-quality studies,
and reproduction in any medium, and accelerating access to new treatments.
provided the original work is
properly cited.
Publisher’s Note: AccScience Keywords: Workload estimation; Ontario Protocol Assessment Level score; Clinical
Publishing remains neutral with trial operations; Research coordinator workload; Protocol complexity; Implementation
regard to jurisdictional claims in
published maps and institutional science; Workforce planning; Coordinator staffing models
affiliations.

Volume 11 Issue 5 (2025) 106 doi: 10.36922/JCTR025260032