药物临床试验质量管理规范平台建设与临床试验质量管理

Good clinical practice platform construction and clinical trials quality control

药物临床试验质量管理规范(GCP)平台建设有利于新药临床试验质量控制整体水平的提高,是保证我国新药研发质量的重要措施。通过药物临床试验机构在十二五期间建设GCP平台,探索提高临床试验质量的具体措施,提升医院整体临床试验能力。

Good clinical practice （ GCP） platform construction was bene-ficial to the improvement of the overall level of quality control on drug clinical trials.It was an important measure to ensure the quality of new drug research in our country.During the twelfth five -year, the drug clinical trial institution constructed GCP platform and explored specific measures to improve the quality of clinical trials.