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,探索风险评估理论和方法在立项风险评估的实践应用,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参考,系统总结了临床科研项目风险特点,并借鉴相关标准和模型,构建相关工作步骤,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、执行能力及风险可控性等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共3个环节。结论临床科研项目立项风险评估十分必要,需从提高意识、建立制度、明确架构及提升技术等方面,以推动此项工作的开展和能力提升。
Objective Through the analysis of the risk factors of clinical scientific research project,risk assessment theory was brought in to develop risk assessment procedures,at the same time,to explore possible applications of risk assessment theories and methodologies in clinical scientific research projects,which might empower the research project administration.Methods Through literature review and the author's scientific research management daily practice,the characteristics of risks involved in clinical scientific research projects were systematically summarized,relevant standards and models were used for reference to develop relevant working procedures,fatherly,methodologies of project risk assessment were discussed.Results There are risks at different stages of scientific research project that including compliance,safety,research topic selection,research design,executive ability and risk-control.A proposal regarding to the implementation of project risk assessment covers three main steps which including preliminary preparation,implementation of risk assessment(risk identification,risk analysis and risk assessment)and risk-response proposal.Conclusions The risk assessment of clinical scientific research projects is crucial.It is necessary to promote the development of risk assessment and improve the capacity building by improving awareness,establishing system,clarifying structure and improving technology.
作者
高熹
常乙玲
Gao Xi;Chang Yiling(Scientific research department of Taizhou People′s Hospital,Taizhou 225300,Jiangsu Province,China)
出处
《中华医学科研管理杂志》
2021年第4期257-262,共6页
Chinese Journal of Medical Science Research Management
基金
泰州市软科学研究计划项目(RKX201821)。
关键词
临床科研项目
立项
风险评估
Clinical research project
Establishment
The risk assessment
