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232 Tyson et al. | Journal of Clinical and Translational Research 2024; 10(4): 229-236
enrolling interventional studies with corresponding coordinator It should be noted that this modification of the OPAL tool
effort tracking from June 1, 2022, to December 1, 2022. Studies was previously tested by the team comparing 11 interventional
that had <6 months of coordinator hours logged against it were protocols [26]. There was a statistically significant difference
excluded from the study. A total of seven studies were included between the average standard OPAL score (3.64 ± 0.5) compared
in the data set. A committee comprised personnel from the to the adapted OPAL score (7.45 ± 1.64; P < 0.0001). Therefore,
MSM Clinical Trials Office then reviewed and graded each the adapted score could differentiate between sensitivities
study protocol using an adapted OPAL tool. between protocol workloads with the same standard OPAL
score.
2.2. Statistical analysis
3. Results
Descriptive statistics were used to compare the protocol
characteristics to the adapted OPAL score and tracked A total of seven protocols were included in the dataset. Of
coordinator hours using Student’s t-test to compare averages. these, 5 (71%) protocols were federally funded compared to
A univariate analysis was performed using non-parametric tests 2 (29%) that were industry-sponsored; 4 (57%) studies were
for the differences in the continuous variables. Linear regression behavioral interventions compared to 3 (43%) drug studies. The
analysis was also performed to assess and quantify the association range of the adapted OPAL scores was 4.75 – 9.0.
between the adapted OPAL score and tracked coordinator hours. There were significant differences between sponsor and
This study is considered a quality improvement study and was intervention types when compared to the adapted OPAL score.
not subject to IRB review or approval. Industry-sponsored studies yielded a higher workload estimate

2.3. Time- and task-tracking application than federally-sponsored studies (7.25 ± 1.77 vs. 6.45 ± 1.65;
P < 0.0001). In addition, behavioral interventions (i.e., exercise
The research coordinators at MSM used a time- and and diet) were estimated at a higher workload assessment than
task-tracking application to monitor the total time spent drug studies (6.88 ± 1.56 vs. 6.42 ± 1.91; P < 0.0001). These
conducting study activities. The application is accessible findings are summarized in Table 3.
through TEAMS, is mobile optimized, and links to the MSM Although industry-sponsored studies and drug studies had
CTMS in real time. Study activities are tracked in broad more coordinator hours tracked against them, there was no
categories: recruitment, communication, scheduling, subject significant relationship between the number of hours tracked
visits, regulatory/compliance, sponsor visits, sponsor training, and the study sponsor type. Industry-sponsored studies
and data entry/query resolution. had an average of 181 ± 152.7 h compared to federally
2.4. Adapted OPAL tool calculation sponsored studies with 98 ± 142.6 h tracked (P = 0.06). Drug
intervention studies had an average of 128.7 ± 141 h tracked
Research protocols were graded using an adapted OPAL compared to behavioral interventions with 116.5 ± 157.6 h
tool. The base score for the adapted tool is derived from the tracked (P = 0.06). These findings are summarized below in
standard OPAL pyramid scale of 1 – 8 (Figure 1). Weighted Table 4.
elements were then added to the base score to calculate the
adapted score. A summary of these weighted elements is Table 3. Protocol characteristics compared to the adapted OPAL
outlined in Table 2. score
Protocol characteristics Adapted OPAL score P
Table 2. Summary of the adapted OPAL-weighted elements Sponsor type
Positively weighted elements Negatively weighted Industry (n=2) 7.25±1.77 <0.0001
elements Federal (n=5) 6.45±1.65
(+) 0.5: On-site monitoring (every 3 months or (-) 0.25: Length of
more) or 100% source document submission; treatment within Intervention type
industry sponsor/Clinical Research Organization 0 – 3 months Drug (n=3) 6.42±1.91 <0.0001
(CRO); multiple surveys or questionnaires (-) 0.5: Visits less Behavioral (n=4) 6.88±1.56
(>3 time points); duration of follow-up visits frequent than every Abbreviation: OPAL: Ontario Protocol Assessment Level.
>2 years; management and oversight of one 4 weeks; no data entry
subsite; management and oversight of >1 subsite;
management of study visits requires travel between Table 4. Protocol characteristics compared to the tracked coordinator
campuses; study requires fresh tissue biopsy; hours
requires sample processing (clotting, centrifuging, Protocol characteristics Tracked hours (h) P
aliquoting, packaging, and shipping); requires
pharmacokinetics (PK) or pharmacodynamics Sponsor type
(PD) labs; length of treatment >18 months (or until Industry (n=2) 181±152.74 0.06
disease progression); inpatient days; study requires Federal (n=5) 98±142.62
specialized personnel (i.e., blinded coordinator or Intervention type
needs more than 1 coordinator); enrollment periodc
≤2 months; and investigator-initiated or pilot study Drug (n=3) 128.67±140.99 0.06
Behavioral (n=4) 116.5±157.61
Abbreviation: OPAL: Ontario Protocol Assessment Level
DOI: https://doi.org/10.36922/jctr.24.00022