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药物临床试验是指在人体(患者或健康志愿体)进行系统的药物研究,以确认或发现临床试验药物药理特点和药物功效方面的作用、不良反应和吸收、分布、代谢和排泄的一系列过程,旨在确定临床试验药物的安全性和有效性[1]。而如何能够保证临床试验质量,确保临床试验数据记录真实、可靠,确保临床试验遵循药物临床试验管理规范(GCP),保证受试者的安全与权益,是临床研究工作者的共同目标。药物临床试验项目实施过程中,该过程中任何
Drug clinical trials refer to the systematic study of drugs in humans (patients or healthy volunteers) to identify or discover the role of pharmacological traits and drug efficacy in clinical trials, adverse reactions, and a series of processes of absorption, distribution, metabolism and excretion , Designed to determine the safety and efficacy of clinical trials of drugs [1]. How to ensure the quality of clinical trials, ensure that clinical trial data records are true and reliable, and ensure that clinical trials adhere to the GCP and ensure the safety and rights of subjects are the common goals of clinical research workers. Drug clinical trial project is implemented during the course of any