Abstract：Through analyzing the new policy situations of filling system of clinical trial facility, on-site data verification and other policies, this paper discusses the importance of establishment and examination work of clinical trial project for medical institutions to undertake high quality projects and avoid medical risks. Taking the establishment of project establishment and examination system as the entry point, thia paper briefly expounds the project establishment and examination procedure of medical institutions, namely project negotiation - project application - project preliminary screening and acceptance - project review. In addition, this paper takes multi-dimension and multi-level analsis for the content of project establishment and key problems needing to be paid attention to, discusses the review contents and methods for the important aspects, such as research basis and scientific significance of the project, experiment design, ethical compliance and research team, and emphasizes the key review of whether the project involves activities related to the collection, collection, export and exit of human genetic resources. This paper takes analysis and discussion focusing on the establishment and examination work of clinical trial project, to provide scientific, standard, rigorous and practical management mechanism and specific operation method for reference for medical institutions to establish normalized project establishment and examination procedure, aimed at strengthening the ability of project establishment and examination of medical institutions and ensuring the project quality.
蔡君龙 吴建元 陈博 周晶晶 林军 黄建英. 医疗机构对临床试验项目立项审查工作的改进方法[J]. 中国医药导报, 2019, 16(18): 159-162.
CAI Junlong WU Jianyuan CHEN Bo ZHOU Jingjing LIN Jun HUANG Jianying. Improvement method of medical institutions for establishment and examination work of clinical trial project. 中国医药导报, 2019, 16(18): 159-162.
2019, Vol. 16 
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