[关键词]
[摘要]
随着中国药物临床研究事业的发展, 临床研究协调员(CRC)作为新兴的行业, 扮演着越来越重要的角色。目前国内尚无统一的行业管理标准与指南, 严重影响了CRC行业的健康发展。基于此, 中关村玖泰药物临床试验技术创新联盟/中国药物临床试验机构联盟起草制定了《临床研究协调员行业管理指南》, 从CRC职业基本要求、培训、等级评估、工作要求、监督管理等方面规范了行业行为。
[Key word]
[Abstract]
The drug clinical researches develop rapidly in China, and clinical research coordinators (CRCs) play more and more important role in pharmaceutical industry. However, there is no mutually recognized guideline for the industry in China, which restricts the healthy development of CRC industry. The "Guideline on CRC Management Practice" is released by Zhongguancun Jiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association to regulate the industry, and it covers the CRC qualification, training, assessment, job requirements, and regulation as well.
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