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一、质量相关方1.药物临床试验的质量涉及申办者/CRO、研究者、SMO、机构办公室、伦委会、监管部门、受试者等。2.各相关人员应始终关注质量问题,切实履行自己的职责,把好质量关。二、质量管理的基本原则1.保护受试者的权益始终是第一位的。2.所有涉及临床试验的人员必须遵照《药物临床试验质量管理规范》和《药品注册管理办法》等法规。3.严格遵守试验方案和相关制度/SOP,确保试
First, the quality of related parties 1. The quality of drug clinical trials involving the sponsor / CRO, researchers, SMO, offices, the Commission, regulators, subjects and so on. 2. The relevant personnel should always pay attention to quality problems, earnestly fulfill their duties, the good quality. Second, the basic principles of quality management 1. To protect the interests of subjects is always the first place. 2. All personnel involved in clinical trials must comply with the “Code of Good Practice for Drug Clinical Trials” and “Drug Registration Regulations” and other laws and regulations. 3. Strict compliance with the test program and related systems / SOP, to ensure that the trial