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《药物临床试验质量管理规范》(GCP)明确规定了药物临床试验相关人员需经过药物临床试验技术与法规的培训,药物临床试验机构需建立人员培训制度。本文结合科室药物临床试验工作实践,总结药物临床试验相关法规对药物临床试验培训的要求,分析药物临床试验培训模式存在的问题并提出对策,探讨GCP培训在药物临床试验的方法和模式,提高药物临床试验水平及质量。提出先行系统培训、针对重点环节培训、抓住存在问题培训等措施,以培训促进各项工作落实,以培训促进药物临床试验质量,以培训贯穿药物临床试验全过程,从而提升临床试验水平。
The Good Clinical Practice (GCP) clearly stipulates that people involved in drug clinical trials need to be trained in the technologies and laws of drug clinical trials, and the drug clinical trial institution needs to establish a personnel training system. Based on the practice of drug clinical trials in departments and departments, this paper summarizes the requirements of drug clinical trial training in laws and regulations related to drug clinical trials, analyzes the problems existing in the training model of drug clinical trials and puts forward countermeasures to explore the methods and modes of GCP training in clinical trials of drugs, Clinical trial level and quality. Pre-emptive system training, focusing on key aspects of training, training and other measures to seize the existing problems to promote training to promote the implementation of the work to promote the quality of clinical trials of drugs to train through the entire process of clinical trials of drugs, so as to enhance the level of clinical trials.