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| 基于PDCA循环的新药临床研究中人类遗传资源管理实践 |
| Practice on Human genetic resources management using PDCA circle in new drug clinical research |
| 投稿时间：2019-09-02 修订日期：2019-09-02 |
| DOI： |
| 中文关键词: 人类遗传资源，新药临床研究，PDCA循环 |
| 英文关键词: human genetic resources new drug clinical research PDCA circle |
| 基金项目:十三五国家“重大新药创制”科技重大专项(2018ZX09734007) |
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| 摘要点击次数: 274 |
| 中文摘要: |
| 【目的】医疗机构立足临床,在疑难危重症疾病新的诊断和治疗方法、新药研发工作中利用人类遗传资源进行国际合作的临床研究越来越多。如何使用PDCA循环,制定和执行人类遗传资源管理规定和管理计划,发现问题,进行整改并进行下一轮计划,确保遗传资源利用的合理合法,维护国家生物安全,是本文的主旨。【方法】文献阅读和调查法。【结果】申办者和研究者意识不断增强，数据样本作为重要的遗传资源信息得到重视，出口出境过程管理加强。【结论】进一步组建专家咨询委员会，设立样本管理员以及定期组织专题培训。 |
| 英文摘要: |
| [Objective]Based on clinical practice, the international clinical researches on the use of human genetic resources in the new diagnosis and treatment of severe diseases and the research and development of new drugs in medical institutions are booming.How to use PDCA cycle in creating and performing genetic resources management regulation and plan,discovery of problems, rectification and next round of plan to ensure the reasonable and legal utilization of genetic resources, and maintain national biosafety, is the main purpose of this paper.[Methods] literature reading and investigation. [Results] The sponsors and researchers have been increasingly aware of the importance of data samples as important genetic resource information, and the export process management has been strengthened. [Conclusion] Expert advisory committee should be further established, sample managers should be set up and special training should be organized regularly.
Key Words: human genetic resources; new drug clinical research;PDCA circle |
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