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Journal of Clinical and
            Translational Research                                       Predicting coordinator workload with adapted OPAL



            Funding                                            conceptualized by artificial intelligence.

            This project was supported in part by the National Center   References
            for Advancing Translational Sciences of the National
            Institutes of Health under Award Numbers UL1TR002378,   1.   Getz KA, Campo RA. New benchmarks characterizing
            UL1 TR001450, and UM1 TR005294, and by the National   growth in protocol design complexity. Ther Innov Regul Sci.
                                                                  2018;52(1):22-28.
            Institute on Minority Health and Health Disparities under
            Award Number 1U24MD015970. The content is solely      doi: 10.1177/2168479017713039
            the responsibility of the authors and does not necessarily   2.   Getz KA, Wenger J, Campo RA, Seguine ES, Kaitin KI.
            represent the  official views of  the  National  Institutes  of   Assessing the impact of protocol design changes on clinical
            Health.                                               trial performance. Am J Ther. 2008;15(5):450-457.
            Conflict of interest                                  doi: 10.1097/MJT.0b013e31816b9027
                                                               3.   Florence Healthcare.  Clinical Trial Complexity Index
            The authors declare that they have no competing interests.   Report; 2023. Available from: https://florencehc.com/
            Author contributions                                  resources/clinical-trial-complexity-index [Last accessed on
                                                                  2025 Apr 20].
            Conceptualization: Kesley Holmes                   4.   Florence Healthcare.  Complexity Costs: Hidden Tolls in
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               Brinton                                            resources/complexity-costs [Last accessed on 2025 Apr 20].
            Investigation: Kesley Holmes, Jan Morgan Billingslea  5.   Gwede CK, Johnsson DJ, Roberts C, Cantor AB. Burnout
            Methodology: Kesley Holmes, Muhammed Idris            in clinical research coordinators in the United States. Oncol
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            Ethics approval and consent to participate         6.   Speicher LA, Fromell G, Avery S,  et al. The critical need
            Not applicable.                                       for academic health centers to assess the training, support,
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            Consent for publication                               coordinators: Recommendations from the clinical and
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            Availability of data                                  doi: 10.1111/j.1752-8062.2012.00423.x
                                                               7.   Morin DJ. Harmonizing protocol complexity with resource
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            reasonable request.                                   Ther Innov Regul Sci. 2020;54:978-987.

            Further disclosure                                    doi: 10.1007/s43441-020-00120-8
            A portion of the findings included in this manuscript was   8.   Smuck  B,  Bettello  P,  Berghout  K,  et al.  Ontario  protocol
            previously presented as a poster at the Southeast Clinical   assessment level: Clinical trial complexity rating tool for
                                                                  workload planning in oncology clinical trials. J Oncol Pract.
            and Translational  Science  Alliance  Conference  held  in   2011;7(2):80-84.
            Pine Mountain, Georgia, United States, in March 2025.
            The presentation, titled “A validation study of the adapted      doi: 10.1200/JOP.2010.000051
            OPAL workload estimation tool,” shared preliminary   9.   Tyson K, Harvey J, Forney L, Brinton D. Resource
            results from the study to facilitate scholarly discussion   management  and  capacity  planning  for  clinical  trial  sites.
            and obtain feedback. The content has since been expanded   J Clin Transl Res. 2024;10(4):229-236.
            and  refined  for  this  manuscript  submission.  The  poster      doi: 10.36922/jctr.24.00022
            has not been published or released by the conference
            organizers. In addition, this paper was polished and edited   10.  Streiner DL, Norman GR, Cairney J. Health Measurement
                                                                  Scales: A  Practical Guide to their Development and Use.
            with the assistance of artificial intelligence-powered tools,   5  ed. Oxford: Oxford Academic; 2015.
                                                                   th
            specifically ChatGPT and Grammarly. These tools were
            used solely to enhance clarity, grammar, and formatting.      doi: 10.1093/med/9780199685219.001.0001
            All content, analyses, and ideas are original and authored   11.  Kottner J, Audigé L, Brorson S,  et al. Guidelines for
            by  the  researchers;  the  project was  not  generated or   Reporting reliability and agreement studies (GRRAS). J Clin


            Volume 11 Issue 5 (2025)                       111                         doi: 10.36922/JCTR025260032
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