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在临床研究中计算机系统常常用于受试者的诊断与管理,药物的调配和执行临床试验方案中规定的实验室检查。确保这些计算机系统每次都严密可控且可信地执行任务非常重要。国际法规要求这些系统均有很好的工作记录方能符合要求。临床基地的稽查和核察人员要按照药物临床试验管理规范要求审查这些系统,确保它们在研究中的可靠性以及数据的可信度。研究组长对所有方案中使用的工作系统以及从书面或计算机中收集的试验数据的质量与可靠性负责。
Computer systems are often used in clinical research to diagnose and manage subjects, to formulate medications, and to perform laboratory tests prescribed in clinical trial protocols. It is important to ensure that these computer systems perform their tasks in a tightly controlled and trusted manner each time. International regulations require that these systems have a good track record of meeting the requirements. Inspectors and inspectors at clinical sites review these systems in accordance with the Code of Practice for Clinical Trials of Drugs to ensure their reliability in studies and the reliability of the data. The study team leader is responsible for the quality of the work system used in all programs and the quality and reliability of the test data collected from the paper or computer.