临床试验中严重不良事件一致性核对的优化  

Optimization of SAE reconciliation in clinical trail

作　　者：周蓓 于浩[2] ZHOU Bei;YU Hao(Jiaxing Tigermed data management Co. LTD, Jiaxing 314006, Zhefiang, China;School of Public Health, Nanjing Medical University, Nanfing 211166, Jiangsu , China)

机构地区：[1]嘉兴泰格数据管理有限公司 [2]南京医科大学公共卫生学院

出　　处：《中国临床药理学与治疗学》2018年第4期428-433,共6页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金(81773554)

摘　　要：目的:利用SAS程序实现安全性数据库与临床数据库严重不良事件一致性核对的半自动化,减轻人工工作量,提高核对的准确性。方法:以某CRO公司的严重不良事件一致性核对为例,通过SAS的Proc import程序将安全性数据库严重不良事件报告读入,与临床数据库中的严重不良事件合并,需进行核对的严重不良事件通过受试者号、不良事件编号或名称排序并导入EXCEL中,而后对两份不良事件中的同一数据点逐条进行比较,通过SAS DDE语言对EXCEL中不一致的数据点进行定位标记,使一致性核对更有针对性且更直观。结果:半自动化方法能够准确定位不一致的数据点,减轻人工核对的工作量,同时通过程序进行筛选匹配,减少了人工操作可能出现的随机错误。结论:此方法能一定程度上辅助人工核查,实现人工核查的半自动化,减少此类核查的人工依赖,保证核对的质量,具有较高的实际应用价值。AIM： To realize the semi-automation of SAE （serious adverse events） reconciliation between clinical database and safety database through SAS （statistic analysis system） program, reduce the manual work and improve the accuracy of reconciliation. METHODS： A CRO company＂s SAE reconciliation was taken as example, the SAE of safety database was imported into SAS through Proc Import procedure, which was combined with SAE of clinical database and was sorted by subject, AE number or AE name; the same variable one by one was compared, located and marked the inconsistent data point in EXCEL by SAS DDE language, the consistency check was more targeted and more intuitive. RESULTS：The inconsistent data point was accurately located and the workload of manual check was reduced; meanwhile, screening and matching through SAS program reduced the random errors which manual operation may produce. CONCLUSION： This method can assist traditional manual check to a certain extent; also, it can reduce the human dependence, guarantee the quality of check and process a high value of practical aPPlication.

关 键 词：临床试验 严重不良事件一致性核对 人工核查 SAS程序 

分 类 号：R969[医药卫生—药理学]