药物临床试验质量管 Good clinical practice
临床试验质量管理规范 good clinical practice ; GCP
药物临床试验质量管理 Good clinical practice
合格的研究者是保证临床试验质量的关键。
Qualified investigators play a key role in guaranteeing the quality of clinical trials.
药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.
方法：结合笔者多年的临床研究工作管理经验，对药物临床试验质量的关键环节和控制措施进行探讨并提出建议。
METHODS:According to the experience of author on clinical research management in many years, key step and control measure of drug clinical trials were explored to put forward recommendations.
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