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Clinical Trial Complexity Measure-Balancing Constraints to Achieve Quality

机译:临床试验复杂性衡量平衡的限制,以实现质量

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摘要

With limited clinical research funding, it is imperative that costs associated with clinical research studies be transparent and measureable to ensure optimal use. The Pediatric Ontario (Oncology) Protocol Assessment Level (Peds-OPAL) provides a mechanism to assess research coordinator workload, a significant component of a clinical research study budget by measuring study complexity. Reflecting research practices congruent with the International Conference on Harmonization Good Clinical Practices, the Peds-OPAL scoring instrument affords investigators and project managers the ability to assess impact on trial quality in relation to constraints of time, cost and scope.
机译:在临床研究资金有限的情况下,与临床研究相关的费用必须透明且可衡量,以确保最佳使用。安大略省儿科(肿瘤学)协议评估水平(Peds-OPAL)提供了一种评估研究协调员工作量的机制,该工作量是通过衡量研究复杂性来衡量临床研究预算的重要组成部分。 Peds-OPAL评分工具反映了与国际统一临床良好做法会议一致的研究实践,使研究人员和项目经理能够根据时间,成本和范围的限制来评估对试验质量的影响。

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  • 会议地点 Crimea(UA)
  • 作者单位

    Clinical Trial Support Unit (CTSU) of Hematology/Oncology, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada;

    Alberta Innovates-Health Solutions, Ste. 1500, 10104- 103 Ave., Edmonton, AB T5J 4A7, Canada;

    Clinical Trial Support Unit (CTSU) of Hematology/Oncology, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada;

    Children's Oncology Group, University of Minnesota, 210 Delaware Street SE, Minneapolis, MN 55455, USA;

    Clinical Trial Support Unit (CTSU) of Hematology/Oncology, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada;

    Clinical Trial Support Unit (CTSU) of Hematology/Oncology, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada;

    Clinical Trial Support Unit (CTSU) of Hematology/Oncology, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada;

    Clinical Trials Support Services, Ontario Institute for Cancer Research (OICR), MaRS Centre, South Tower, 101 College St., Suite 800, Toronto, ON M5G 0A3, Canada;

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