专案管理对药物临床试验原始记录书写质量的影响分析

Analysis of the influence of project management on the writing quality of original records of drug clinical trials

目的分析专案管理对药物临床试验原始记录书写质量的影响。方法回顾性分析2019年9月至2020年12月本院(实施专案管理前)804份药物临床试验原始记录作为常规记录组,另选取2021年1月至2021年9月(实施专案管理后)702份药物临床试验原始记录作为专案管理组,比较两组原始记录书写问题及临床试验满意度。结果专案管理组原始记录字迹潦草难以辨认、修改内容不规范、记录不及时、存在缺项漏项、未填写记录时间、位置填写不正确占比均低于常规记录组,差异有统计学意义(P<0.05)。专案管理组临床试验满意度为99.72%,高于常规记录组的96.52%,差异有统计学意义(P<0.05)。结论在药物临床试验中应用专案管理模式,能大幅提高原始记录的书写质量,提高药物临床试验管理的规范化、专业化水平和药物临床试验的质量水准,更符合研究人员的临床试验需求,值得推广应用。

Objective To analyze the influence of project management on the writing quality of original records of drug clinical trials.Methods 804 original records of drug clinical trials our hospital from September 2019 to December 2020(before the implementation of project management)were retrospectively analyzed as the routine record group,and 702 original records of drug clinical trials from January 2021 to September 2021(after the implementation of project management)were selected as the project management group,the writing problems of the original records and clinical trial satisfaction of the two groups were compared.Results The proportion of original record handwriting is illegible,the modified content is not standardized,the record is not timely,there are missing items and missing items,the record time is not filled in,and the location is not filled in correctly in project management group were lower than those in routine record,and the differences were statistically significant(P<0.05).The satisfaction degree of clinical trial in the project management group was 99.72%,which was higher than 96.52%in the routine record group,and the difference was statistically significant(P<0.05).Conclusion The application of project management mode in drug clinical trials can greatly improve the writing quality of original records,improve the standardization and specialization level of drug clinical trial management and the quality level of drug clinical trials,which is more in line with the clinical trial needs of researchers and,which is worthy of clinical promotion and application.