药物临床试验记录文件中常见问题及规范实施办法探讨

Common problems of clinical trial records and improvement measures of qulity control

目的:总结临床试验记录文件中常见的问题,提出规范的文件记录做法,为提高药物临床试验数据记录质量提供参考。方法:参照药物临床试验质量管理规范,结合作者从事药物临床试验质量控制工作的经验,对实际工作中发现的临床试验记录文件中存在的问题进行分析,并探讨符合药物临床试验规范的文件记录做法和相关措施建议。结果:研究者和监察员的综合素质是影响药物临床试验记录文件质量的主要原因。结论:加强对研究者和监察员的试验资质考察、GCP和SOP培训,对临床试验进行项目组、专业组和机构办公室三级质量控制监管,引入国外SMO管理模式、聘请CRC,建立药物临床数据信息化系统是提高药物临床试验记录文件质量的办法。

Objective： To summarize common problems in clinical trial record files and provide recommendations for improving the quality of data recording in drug clinical trials. Methods： On the basis of GCP and the author＇s experience in quality control of clinical trial, common problems in clinical trial record files were analyzed and the improvement measures were discussed. Results： The overall qualities of investigator and CRAs in clinical trial were the main factors influencing the quality of clinical trial records. Conclusion： There were several suggestions for improving the quality of clinical records, such as reinforcement of the qualification management and GCP or SOP training of investigators and CRAs, implementation of three-level quality control system of drug clinical trial, introduction of foreign SMO management mode and CRC service, and establishment of clinical data information system.