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临床试验(clinical trial)是指任何在人体(患者或健康志愿者)进行药物的系统性研究,以证实或揭示试验药物的作用、不良反应和(或)试验药物的吸收、分布、代谢和排泄,目的是确定试验药物的疗效与安全性。其研究结果的各项数据是药品注册及上市销售的重要依据。试验用药品(investigational product)是在临床试验中使用的试验药物、对照药品或安慰剂。应急信件中的信息是试验用药真实身份的指示,每一份药对应一份应急信件。若试验用药与应急信件的管理不够规范,可能导致各项记录缺失、药物变质、非时间窗发药、应急信件丢失而不能及时破盲等问题,从而影
Clinical trial refers to any systematic study of drugs in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions and / or absorption, distribution, metabolism, and excretion of test drugs , The purpose is to determine the efficacy and safety of experimental drugs. The results of the data is an important basis for drug registration and marketing. The investigational product is the test drug, control drug, or placebo used in the clinical trial. The information in the emergency letter is an indication of the true identity of the test medication, and each copy corresponds to an emergency letter. If the test medication and emergency letter management is not standardized, may result in the lack of records, drug deterioration, non-time window dispensing, the loss of emergency letters and other issues can not be promptly broken, so as to