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Tyson et al. | Journal of Clinical and Translational Research 2024; 10(4): 229-236 231

1 = observational
study + 1 visit
2 = observational
study + 2 or
more visits
3 = Phase II/III/IV study +
interventional + non-drug
(i.e., dietary or exercise)
4 = Phase II/III/IV + interventional +
drug treatment + 1 SP (i.e., ECG and
DEXA scan) and/or CP (i.e., central lab)
5 = Phase II/III/IV + interventional + drug treatment
+ 2 or more SP or CP

6 = Phase II/III/IV + interventional + drug treatment + single SP +
multiple CP or Phase II/III/IV + interventional + drug treatment +
single CP + multiple SP
7 = Phase II/III/IV + interventional + drug treatment +
multiple SP + multiple CP

8 = Phase I

Figure 1. Ontario Protocol Assessment Level (OPAL). Adapted from Smuck et al. [16]
Abbreviations: ECG: Electrocardiogram; DEXA: Dual-energy x-ray absorptiometry; CP: Central processes; SP: Special procedures
Table 1. Examples of CP and SP site and assist in budget negotiations with sponsors. Tracking
CP SP actual effort may help capture hidden costs associated with
Use of central laboratory; central Imaging (i.e., MRI); ECG; internal processes due to real-time dynamic tracking allowing
eligibility review; central tissue biopsy; and cognitive testing clinical research leaders to make better-informed decisions to
review; and central ECG review assess capacity and improve operational efficiency.
Abbreviations: CP: Central processes; SP: Special procedures; ECG: Electrocardiogram; To date, there have been no known attempts to link the OPAL
MRI: Magnetic resonance imaging score to the coordinator’s effort. Therefore, this study applies
resource management and capacity planning principles to
However, the OPAL tool has limited sensitivity in examine the workload of research coordinators at an academic
differentiating workloads between studies with the same score. research center by linking an adapted OPAL score with tracked
Moreover, the utilization of the OPAL tool fails to consider crucial coordinator effort. In detail, this study will map an adapted OPAL
factors, such as organizational structure, budget constraints, score for clinical trials to actual coordinator hours from a single
and patient demographics, all of which significantly impact site to determine if the adapted OPAL score can be a predictor
the effort and productivity of research coordinators [11,20,21]. of coordinator hours. With this strategy, research sites can better
These limitations suggest that the tool alone may not provide allocate resources and improve operational efficiency, reduce
a comprehensive assessment of workload. To address these burnout and turnover among CRCs, and ultimately contribute to
shortcomings, enhancements such as linking the research the success of clinical trials. By systematically evaluating the
coordinator’s tracked effort over time with an adapted OPAL complexity and demands of the CRC’s workload, we aim to
score may provide a more accurate assessment of workload. The provide insights into the specific resource needs. Furthermore,
data can then be used to establish a precedent for the site and assist the data from this project can highlight trends and areas where
in budget negotiations with sponsors. Tracking actual effort may additional training or support may be needed for CRCs to better
help capture hidden costs associated with internal processes due equip them with the necessary skills and knowledge. This
to real-time dynamic tracking allowing clinical research leaders targeted approach to capacity planning and resource management
to make better-informed decisions to assess capacity and improve will not only enhance the efficiency of clinical trials but may also
operational efficiency. Richie et al. [15] demonstrated the utility improve job satisfaction and retention rates among CRCs.
of this integrated approach, but assumed that estimated effort
from past contracts was not over or underestimated instead of 2. Methods
using actual effort. Likewise, in addition, measuring coordinator 2.1. Research design
activity over time can provide a pattern demonstrating where
study assignments result in maximum productivity [20]. The The Morehouse School of Medicine (MSM) Clinical
historical data can then be used to establish a precedent for the Trials Management System (CTMS) was queried for actively

DOI: https://doi.org/10.36922/jctr.24.00022