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监查（Monitoring）
一、定 义
监查：是指对试验记录与报告进行核对，确保其数据准确性和完整性，保证试验遵循已批准的方案和有关法规进行，使临床试验中受试者的权益受到保障。1)
Monitoring：The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).2)
监查员：即Clinical Research Associate (CRA) 或 Monitor，是由申办者任命并对申办者负责的具备相关知识的人员，其任务是监查和报告试验的进行情况和核实数据。3)