药物临床试验药物管理员核心能力评价指标体系构建及应用OA

Objective To construct a core competency assessment index system for drug administrators in drug clinical trials(hereinafter referred to as drug administrators)in China,and to evaluate the core competencies of drug administrators.Methods A preliminary core competency assessment index system was constructed through literature research and expert consultation methods from the perspectives of the role positioning,job responsibilities,and work scope of drug administrators,and the index system was modified and validated by the Delphi method.Based on the constructed assessment index system,an electronic questionnaire survey was conducted among drug administrators from 38 drug clinical trial institutions.Wilcoxon signed-rank test was used to compare the role-importance and self-competence scores scores of drug administrators in various indexes of core competencies.Results A total of 19 experts completed two rounds of Delphi expert inquiry,with expert positivity coefficients of 100.00%and 95.00%,expert authority coefficient of 0.929,and expert Kendall's W coordination coefficients of 0.236 and 0.278,respectively(all P<0.001).The core competency assessment index system of drug administrators consisted of three first-level indicators and thirty-five second-level indicators.A total of 95 questionnaires were distributed to 38 drug clinical trial institutions,and 95 valid questionnaires were collected,with an effective response rate of 100.00%.In the dimension of individual professional competency,two out of nine indicators showed a significant difference between self-competence score and role-importance score(P<0.05).In the dimension of drug management competency,three out of tweenty-one indicators showed a significant difference(P<0.05).In the dimension of quality control competency,one of five indicators showed a significant difference(P<0.05).Conclusion The core competency assessment index system of drug administrators constructed by the Delphi method can provide an objective and quantifiable basis for the assessment of drug administrators'core competencies,and can also provide a reference for the construction of a standardized drug administrator education and training system.