Construction of risk assessment index framework for clinical research in China based on Delphi method
Objective:To construct a clinical research risk assessment index framework based on China's national conditions,providing standards and basis for clinical research risk assessment.Methods:On the basis of previous literature review and expert interviews,two rounds of Delphi consultation were conducted.The results of expert consultation were evaluated from the perspectives of mean,variation index and coordination coefficient,and the core indicators of clinical research risk assessment were further screened and optimized.Results:A total of 23 experts in this field were selected to conduct this questionnaire survey.The positive degree of experts in the two rounds was 100％with the authority coefficient ≥0.90.According to the mean value and coefficient of variation of the indicators,combined with expert's modification suggestions,a clinical research risk assessment framework was finally constructed,including 4 first-level indicators,10 second-level indicators and 45 third-level indicators.Conclusion:The clinical research risk assessment framework constructed in this study can help ethics committees of medical institutions to quickly assess and find potential risk points,improve the quality and the level of ethical review,providing a basis for the future development of quantitative clinical research risk assessment tools.
NETL
NSTL
万方数据
