文章摘要
风险评估在临床科研项目立项中的应用与实践
Application and Practice of Risk Assessment in Clinical Research Project Approval
投稿时间:2020-12-21  修订日期:2021-04-20
DOI:
中文关键词: 临床科研项目  立项  风险评估
英文关键词: Clinical research project  Establishment  The risk assessment  
基金项目:泰州市软科学研究计划项目,编号RKX201821
作者单位邮编
高熹 泰州市人民医院 225300
常乙玲 泰州市人民医院 225300
摘要点击次数: 28
中文摘要:
      [目的]通过对临床科研项目立项存在的风险成因分析,引入风险评估理论,构建风险评估步骤,探索风险分析流程图法的应用,丰富科研项目管理的手段和方法。[方法]通过文献综述和笔者科研管理工作实践,系统总结了临床科研项目风险特点,借鉴相关标准和模型,构建了相关工作步骤,探讨了立项风险评估的一些方法应用。[结果]科研项目立项阶段在合规性、安全性、研究选题、研究设计、执行能力、风险可控性等6个维度存在风险;立项风险评估实施步骤包括:前期准备、风险评估实施(风险识别、风险分析和风险评价)和提出风险应对建议三个阶段;且风险分析流程图法能够实现立项快速风险评估。[结论]临床科研项目立项风险评估十分有必要,需从提高意识、建立制度、明确架构、提升技术等方面,来推动此项工作的开展和能力提升。
英文摘要:
      [Objective] Through the analysis of the risk causes of clinical scientific research project, the introduction of risk assessment theory, the construction of risk assessment process, explore the application of risk analysis flow chart method, enrich the means and methods of scientific research project management. [Methods] Through literature review and the author's scientific research management practice, the risk characteristics of clinical scientific research projects were systematically summarized, relevant standards and models were used for reference, relevant work steps were constructed, and some methods of project risk assessment were discussed. [Results] There are risks in 6 dimensions, including compliance, safety, research topic selection, research design, executive ability and risk controllability. The implementation steps of project risk assessment include: preliminary preparation, implementation of risk assessment (risk identification, risk analysis and risk assessment) and proposal of risk response. And the flowchart method of risk analysis can realize the rapid risk assessment of project approval. [Conclusion] The risk assessment of clinical scientific research projects is very necessary. It is necessary to promote the development of this work and improve the ability from the aspects of improving awareness, establishing system, clarifying structure and improving technology.
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