临床试验相关方期望CRC具备核心胜任能力的调查分析

Investigation and Analysis of the Core Competencies Expected of CRC by Clinical Trial Participants

摘要: 目的：调查临床试验参与者期望临床研究协调员(CRC)具备的胜任能力，为CRC聘任、培训管理及核心胜任能力提高提供参考依据。方法：运用文献法及半结构化访谈法确定调查问卷，通过微信发送问卷星链接进行网络问卷调查。采用Microsoft Office Excel 2016、IBM SPSS Statistics 25.0软件对数据进行缺失值、极端值处理，利用频数和百分比对计数资料进行统计描述。结果：127名三级甲等综合性医院承接的临床试验相关方参与了问卷调查，包括研究者、申办方及SMO工作人员。调查问卷内容效度评价者间一致度为0.94，量表水平S-CVI/UA为0.91，问卷整体内容效度表现良好。信度克隆巴赫系数为0.97，问卷评价条目内部一致性较好、信度较高。123例(96.85%)被调查者认为CRC在临床试验GCP/伦理基础知识和严格执行GCP原则和法规的重要程度达到6分以上；122例(96.07%)被调查者认为熟悉临床试验方案及研究流程的重要程度在6分以上；80%以上的被调查者认为数据管理方面的重要程度在6分以上；80%以上的被调查者认为CRC用于项目的时间精力、工作主动性、工作态度、责任心、团队协作能力重要程度在6分以上。结论：CRC要有扎实的GCP/伦理基础知识和严格执行方案的意识，较强的沟通协调能力、持续学习能力和团队协作精神。在建立CRC培训和晋升体系时应关注CRC实践能力和沟通能力的提升。

Abstract: Object: To investigate the competencies that clinical trial participants expect from clinical research coordinators (CRC) to provide a reference for CRC's appointment, training management and core competency improvement. Methods: The questionnaire was determined by the literature method and semi-structured interview method, and the questionnaire star link was sent through WeChat to conduct the online questionnaire survey. The questionnaire was determined by the literature method and semi-structured interview method, and the questionnaire star link was sent through WeChat to conduct the online questionnaire survey. Microsoft Office Excel 2016 and IBM SPSS Statistics 25.0 software are used to deal with missing values and extreme values, and count data are statistically described with frequency and composition comparison. Results: The inter-evaluator consistency of the questionnaire content validity is 0.94, and the scale level S-CVI/UA is 0.91, which shows that the overall content validity of the questionnaire performs well. The reliability of Cronbach’s coefficient is 0.97, which shows that the internal consistency and reliability of the ques-tionnaire evaluation items are good. 123 (96.85%) respondents believed that the importance of CRC in clinical trials GCP/ethics basic knowledge and strict implementation of GCP principles and regulations reached more than 6 points. 122 people (96.07%) of the surveyed considered that the importance of being familiar with the clinical trial protocol and research process was above 6 points. More than 80% of respondents believe that the importance of data management is above 6 points. In terms of personal ability, more than 80% of the respondents believe that the importance of CRC's time and energy, work initiative, work attitude, sense of responsibility, and teamwork ability for the project is more than 6 points. Conclusion: CRC must have a solid GCP/ethics basic knowledge and a sense of strict implementation of the plan, excellent communication and coordination skills, continuous learning ability and teamwork spirit. When establishing a CRC training and promotion system, attention should be paid to the improvement of CRC's practical ability and communication ability.