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2014年9月5日，国家食品药品监督管理局颁布了《药物临床试验机构资格认定检查细则(试行)》征求意见稿，该文件是总局审核查验中心根据《药物临床试验质量管理规范》以及药物临床试验机构管理的有关规定，对《药物临床试验机构资格认定标准》的相关条款进行全面细化而产生。本文将主要从《药物临床试验机构资格认定检查细则》(试行)的制定意义、检查内容、检查方法以及存在问题等几个方面进行阐述，为药物临床试验机构迎接资格认定检查工作及规范管理提供一定参考。“,”September 5, 2014, the State Food and Drug Administration issued a “drug clinical trial institution accreditation inspection rules (Trial)” the draft, the document is in accordance with the General Administration of audit inspection center“Good Clinical Practice” and drugs relevant provisions of the institutional management of clinical trials, on the “clinical test qualification standards,”the relevant provisions of the overal refinement and production. This article wil focus on the “drug clinical trial institution recognized qualification examination Rules” (Trial) formulation meaning, check the contents of several aspects, inspection methods and problems and so forth, to meet the qualification checks and standardize the management of clinical trials for drug agencies certain reference.