关键词: font-size:medium, ">临床试验；质量控制；质量管理；标准；药物临床试验质量管理规范

Abstract: Objective： To establish internal clinical trial quality control (QC) standards and standardize clinical trial QC work. Methods： The QC standards were classified according to the implementation period and the key points of QC. The QC standards， including the project start-up rules， informed consent， screening list， researcher folder， etc. as the unit module QC rules， were formulated. And the implement of QC was in accordance with the established QC standards. Results： The clinical trial QC standards consisting of classification， standard rules， procedures， problem determination of QC were established. 26 quality control inspections were carried out in accordance with the standards， and a total of 327 problems were found， of which 8 were main questions， 87 were minor questions， and 232 were general questions，and no major problems were found. Conclusion： The established quality control standard of clinical trials has strong operability， can effectively standardize the quality control behavior of clinical trials， and has certain practical and reference value.

Key words: font-size:medium, ">Clinical trial； Quality control； Quality management； Standards； Good clinical practice