我院药物临床试验培训存在的问题与对策

发布时间：2019-01-13 06:49

【摘要】：目的:探讨药物临床试验培训的方法和模式,提高药物临床试验水平及质量。方法:总结药物临床试验相关法规对药物临床试验培训的要求,以我院为例分析药物临床试验培训模式存在的问题并提出对策。结果与结论:药物临床试验相关法规明确规定了药物临床试验相关人员要经过药物临床试验技术与法规的培训,药物临床试验机构要建立人员培训制度。针对临床试验相关人员对临床试验的认知水平较低、现有资格认定的培训内容与临床试验工作需求有落差、研究者对临床试验进行过程中的培训不够重视等问题,建议采取加强管理和监督、结合临床试验需求组织培训、加强监查员管理等措施;同时建议有关部门加强监督和管理,结合药物临床试验工作需求进行培训,以确保药物临床试验培训效果,从而提升临床试验水平。
[Abstract]:Objective: to explore the methods and modes of drug clinical trial training and to improve the level and quality of drug clinical trial. Methods: the requirements of drug clinical trial training were summarized. The problems of drug clinical trial training model were analyzed and countermeasures were put forward. Results & conclusion: the relevant laws and regulations of drug clinical trials clearly stipulate that the relevant personnel of drug clinical trials should be trained in the techniques and regulations of drug clinical trials and the personnel training system should be established in drug clinical trials institutions. In view of the low level of cognition of the clinical trial personnel, the difference between the existing qualification training content and the requirement of clinical trial work, and the lack of attention to the training during the clinical trial, and so on, Measures should be taken to strengthen management and supervision, organize training according to the needs of clinical trials, and strengthen the management of supervisors. At the same time, it is suggested that the relevant departments should strengthen supervision and management and conduct training in combination with the requirements of clinical drug trials to ensure the effectiveness of training in drug clinical trials so as to improve the level of clinical trials.
【作者单位】：沧州市中心医院;黄骅市人民医院;
【基金】：沧州市软科学研究计划项目:地市级医院药物临床试验机构建设与管理(No.1123140ZD)
【分类号】：R95

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