Application and practice of risk assessment in clinical research project approval / 中华医学科研管理杂志

ABSTRACT

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.