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230 Tyson et al. | Journal of Clinical and Translational Research 2024; 10(4): 229-236
challenges, such as mistrust of medical systems, socioeconomic increased costs. This quantitative assessment allows for better
barriers, and the lack of health-care access. These challenges planning and distribution of workloads among CRCs, ensuring
necessitate tailored recruitment strategies, adding another that each coordinator’s capacity is optimally utilized without
layer of complexity to conducting clinical trials. Thus, both the overburdening them [16,20].
logistical challenges of remote studies and the specific needs In general, the OPAL score is calculated based on a pyramid
of underrepresented communities contribute to the increasing scale from one to eight of incremental procedures representing an
complexity of trials [3-5]. increase in trial complexity (Figure 1). Scoring ranges from non-
The Clinical Research Coordinator (CRC) plays an integral treatment trials with low contact (OPAL score = 1) and increases
role in the success of clinical trials and manages various to the more complicated Phase I trials (OPAL score = 8). The
aspects of studies. Core responsibilities often include recruiting number of contacts, study type, study phase, number of special
subjects, conducting study visits, maintaining study documents, procedures, and the number of central processes are considered
and acting as a liaison between clinical, regulatory, and when reviewing the protocol. Examples of central processes and
administrative personnel. However, additional responsibilities special procedures are outlined in Table 1. The tool allows for
such as regulatory submissions, budget development and calculating optional elements that may influence complexity,
negotiation, and managing study finances may be required [6-9]. such as adding or decreasing weight in 0.5 increments to account
This role requires specialized skills, training, and medical for the number of study visits or the increased administrative
knowledge due to increased protocol complexity and regulatory work required when managing industry-sponsored trials. This
oversight [6]. Given the 65% increase in the number of allows sites to adapt the tool to account for unique protocols and
clinical trials registered between 2015 and 2019 [2], the pool institutional needs. In addition, the tool measures case, total,
of clinical trial workforce professionals has steadily decreased and departmental workloads. The case workload represents the
since the nineties resulting in a national shortage of qualified participant management component of the trial. The number of
professional coordinators. The shortage is partly attributed to participants and their study status, such as on or off intervention,
increased regulatory burdens, protocol complexity, and staff affect the case workload score. Active case workload is defined
burnout [6-7,10,11]. Increased responsibilities and workload as the number of subjects on study intervention. It is calculated
have negatively affected job satisfaction, leading to coordinators by multiplying the number of participants on intervention by
remaining in the position for a shorter time. This high turnover the OPAL score. For example, if a trial is considered to have
rate is costly and adversely affects the timely management of an OPAL score of 4 and has five active participants on study
clinical trials [6,11]. Organizations such as the Association of intervention, then the active case workload score would be
Clinical Research Professionals and the Society of Clinical 20 (4 [OPAL score] × 5 [active subjects]). If a participant has
Research Associates attempt to grow the clinical trial workforce completed study treatment, but follow-up visits continue, they
by validating staff qualifications, defining competencies, and are now considered a follow-up case. A trial can have both
establishing clear career paths. However, despite these efforts, active and follow-up cases. The follow-up case workload is
the professional workforce continues to diminish. Furthermore, also calculated using OPAL. The OPAL score is divided in half
the COVID-19 pandemic complicated trial management and due to the reduced workload. The score is then multiplied by
disrupted operations, preventing many sites from continuing their the number of participants in the follow-up phase of the study.
existing trial activities [12,13]. As institutions resume regular For example, if a study has an OPAL score of 4 and has one
operations, many are now facing staffing shortages [12,14]. participant in follow-up, then the follow-up case score would
Therefore, clinical trial leaders must develop tools to assist with be 2 (4 [OPAL score]/2; then 2 × 1 [follow-up participant]). The
managing workloads to help combat burnout. case workload score can now be calculated by adding the active
To address these issues and retain staff, sites should and follow-up case scores. OPAL score and case workload
effectively assess workloads and capacity [15]. Workload are added to create the total workload. This score represents
assessments help provide validation to increase staff, evaluate an objective measurement of the research coordinator’s
and ensure equal distribution of work, and assist with budget workload. The total workload for each protocol is then summed
justifications. Multiple tools have been created to calculate the to represent the department workload [16]. Factors such as
workload of a clinical trial and measure the CRC’s capacity to protocol amendments, increased or decreased target enrollment
manage it, aiding in study assignments [11,16-20]. The Ontario goals, and changing study timelines can alter the complexity
Protocol Assessment Level (OPAL) is designed to quantify score throughout a study so it is suggested to assess the
the complexity of clinical trial protocols by analyzing factors workload at least quarterly [16,20]. Understanding the OPAL
such as the trial phase, the type of intervention, and the number calculation provides insights into how integrating longitudinal
of special procedures. In addition, the OPAL score has been data on coordinator efforts modifies traditional complexity
validated in oncology and non-oncology studies [7,16,21-25]. assessment, justifies OPAL score adaptation, enhances
The tool can also be adapted to calculate optional elements that resource allocation and workload management, and ensures
may affect complexity, such as high enrollment requirements methodological transparency. In addition, it contextualizes the
with short recruitment timelines. By assigning a complexity adapted OPAL score within the broader framework of clinical
score to each protocol, the tool helps identify trials that may trial management, highlighting its potential to improve trial
require more resources or present higher risks of delays and efficiency and coordinator satisfaction.

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