临床研究协调员在药物临床试验实施中的常见质量问题及对策

Common Problems and Counter Measures of Clinical Research Coordinator in Drug Clinical Trails

临床研究协调员(CRC)作为临床试验的重要参与者,其业务能力和职业素养直接影响临床试验质量。本研究基于药物临床试验质量控制工作经验,总结了在临床试验实施中CRC人员资质与职责分工、数据记录、文档管理、药品管理、生物样本管理、受试者管理等方面存在的质量控制常见问题。我国CRC尚处于发展阶段,存在行业标准缺乏、能力参差不齐等缺陷,临床研究机构和申办方均应采取质量应对措施,进一步保证临床研究的科学性、严谨性和规范性。建议建立机构现场管理组织(SMO)优选制度、CRC准入及培训制度,建设临床试验信息化平台,加强质量控制及受试者保护。

As specific participant in clinical trials,the operational ability and professional competence of clinical research coordinator(CRC)directly affects the quality of clinical trials.In order to improve the quality of the drug clinical trails,based on the quality control experience of drug clinical trials,this article summerized the common quality problems related to CRCs during the implementation of drug clinical trials,such as qualifications and authority,data recording,file management,drug management,biological sample management and subject management.CRC in China is still at the stage of development,and there are some defects such as lack of industry standards and uneven capacity.Both the clinical research institution and the sponsor should take counter measures to further ensure the scientific,rigorous and standard of clinical studies,such as siting management organization(SMO)optimization system and CRC admittance and training system,establishing the information platform of clinical trials,strengthening quality control and subject protection.