药物临床试验机构质量控制回顾性分析

Retrospective Analysis of Quality Control in Drug Clinical Trial Institutions

目的对常州市肿瘤医院药物临床试验机构质量控制方面所存在的问题进行回顾性分析并提出相关针对性解决方案.方?法选取2019年1月至8月常州市肿瘤医院肿瘤相关专业的药物临床试验机构质控检记录资料作为研究对象,对其中所出现的问题进行回顾性分析.结果常州市肿瘤医院药物临床试验机构质量控制方面所存在的问题包括:机构管理层、专业组尚缺乏一定经验;质控体系缺乏完善性且相关人员不足;培训力度不够.结论医院应当加强相关培训,建立更为完善的临床试验质控体系,进一步完善人员构建.

Objective To analyze the problems in quality control of drug clinical trial institutions in Changzhou tumor hospital and put forward relevant solutions.Methods The quality control records of drug clinical trial institutions of tumor related specialty in Changzhou tumor hospital January to August 2019 were selected as the research object,and the problems in the records were analyzed retrospectively.Results The problems of the quality control of drug clinical trial institutions in Changzhou Tumor Hospital included:management of the organization and the professional group still lack certain experience;The quality control system is not perfect and the related personnel is insufficient;Not enough training.Conclusion The hospital should strengthen related training,establish more perfect clinical trial quality control system,and further improve personnel construction.