构建中国临床研究协调员能力评估模型:基于德尔菲方法和问卷调查的研究
Yanhong Zhu1, Xiang Sun2, Maohang Cai1
1School of Health Policy and Management, Nanjing Medical University, Nanjing, Jiangsu Province, China.
BMJ open
|September 17, 2024
概括
开发了中国临床研究协调员 (CRC) 的新能力模型. 这种具有4个维度和37个指标的模型经过验证,以加强临床试验中的CRC培训和管理.
科学领域:
- 临床研究管理 临床研究管理
- 医疗保健工作人员发展发展.
- 专业能力评估评估专业能力评估
背景情况:
- 中国的临床试验数量正在迅速增加.
- 评估临床研究协调员 (CRC) 的能力至关重要,但具有挑战性.
- 需要对CRC行业进行标准化和监管.
研究的目的:
- 为 CRC 构建一个专门针对中国环境的能力模型.
- 促进中国CRC行业的标准化和受监管的发展.
- 为评估CRC能力提供基础.
主要方法:
- 使用文献综述,半结构面试和德尔菲专家咨询.
- 分析层次过程和问卷调查被用于模型构建和验证.
- 广泛的中国CRC样本参与了这项研究.
主要成果:
- 完成了一个具有4个核心维度和37个指标的能力模型.
- 调查问卷实现了81.83%的有效响应率.
- 因子分析证实了模型的可靠性和有效性 (克朗巴赫的α>0.7).
结论:
- 这项研究开创了对中国CRC的验证能力模型和评估尺度.
- 这些发现对CRC的招聘,培训,开发和管理有重大影响.
- 该模型支持中国CRC行业的标准化和受监管的增长.
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