创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

基于冰山理论的药品GCP试验临床研究协调员胜任力培训课程体系构建

Establishment of a Competency Training Curriculum System for Clinical Research Coordinators in Drug GCP Trials Based on the Iceberg Theory

  • 摘要: 目的 构建符合我国《药物临床试验质量管理规范》(good clinical practice,GCP)和临床试验发展需求的临床研究协调员(clinical research coordinator,CRC)胜任力培训课程体系,为CRC标准化、专业化培养提供参考。方法 通过文献检索、访谈调研梳理国内外药品GCP框架下CRC胜任力评价指标体系与课程体系,采用德尔菲法对37位临床研究领域专家进行咨询,形成我国CRC胜任力培训课程体系。结果 建立了包含9项胜任力、12门课程的CRC胜任力培训课程体系。其中,“冰山以上”含“专业知识”“学习理解能力”等6项胜任力,对应9门课程;“冰山以下”含“诚信、合规、守法”等3项胜任力,对应3门课程。3轮咨询中,专家咨询积极系数分别为100.0%、97.3%和100.0%,专家权威系数分别为0.850、0.875和0.925,一级指标专家协调系数分别为0.348、0.414,二级指标专家协调系数分别为0.402、0.432和0.521。结论 本研究基于冰山理论所构建的CRC胜任力培训课程体系,兼顾显性、隐性胜任力的培养,能够为推进CRC培养体系标准化建设提供有益参考。

     

    Abstract: Objective To establish a clinical research coordinator (CRC) curriculum system that aligns with Chinese good clinical practice (GCP) and the developmental needs of clinical trials, thereby providing a reference for the standardized and professional training of CRCs. Methods Through literature review and interview-based research, the competency evaluation indicator system and curriculum system of CRCs under domestic and international GCP frameworks were reviewed and synthesized. The Delphi method was used to consult 37 experts in the field of clinical research, forming a competency training curriculum system for CRCs in China. Results A CRC competency training curriculum system was established, which includes 9 competencies and 12 courses. Among these, the “above-iceberg”covers 6 competencies (e.g., “professional knowledge”and“learning and comprehension ability”) corresponding to 9 courses; the“below-iceberg”includes 3 competencies(e. g.,“integrity, compliance, and law-abiding”) corresponding to 3 courses. Across three rounds of consultation, the expert response rates were 100.0%, 97.3%, and 100.0%, respectively. The expert authority coefficients were 0.850, 0.875, and 0.925, and the coordination coefficients for the primary indicators were 0.348 and 0.414, while those for secondary indicators were 0.402, 0.432, and 0.521, respectively. Conclusion Based on the iceberg theory, this study constructed a CRC competency training curriculum system that addresses both explicit and implicit competencies, and can provide a useful reference for promoting the standardization of the CRC training system.

     

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