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(广东省药学会2016年8月4日印发)起草说明药物临床试验的安全性评价是全面、客观评价一个试验药物不可或缺的内容。安全信息的收集、评价和记录主要由研究者团队完成,但申办者所撰写的研究方案和制定的实施细则是确保高质量信息收集和整理等工作的关键性因素。药物临床试验过程中,安全性评价环节一直是研究各方存在争议的部分。但迄今,在信息发现、收集
(Guangdong Pharmaceutical Association August 4, 2016 issued) to draw up that the safety evaluation of clinical trials of drugs is a comprehensive, objective evaluation of an experimental drug indispensable content. The collection, evaluation and recording of safety information are mainly done by the team of researchers. However, the sponsor’s research plan and the detailed implementation rules are the key factors for ensuring the quality of information collection and collation. In the course of drug clinical trials, safety evaluation has always been a controversial part of the study. But so far, the information is found, collected