摘要
目的分析ICH E2B(R3)指南文件中涉及质量的内容,了解指南中关于个例安全性报告的数据质量的要求。方法通过梳理ICH E2B(R3)指南文件中数据元素与人类对事物的认知,从数据、信息、知识最后升华为智慧,整个循序递进的过程联系在一起进行分析论证,找出影响数据质量的因素与可视化维度。结果数据的质量体现在数据的完整性(数据维度)和数据的精准性(粒度),E2B(R3)指南文件中对数据关系和数据元素的要求有效保证了个例报告的质量,根据E2B(R3)指南进行相关设计可获取高质量的药物安全相关数据。结论上市许可申请人及持有人在设计安全性信息收集表时,需要根据ICH E2B(R3)实施指南从数据精确性与完整性的角度上保证数据质量,高质量的数据在安全性数据库中不断累积,从而发现潜在药品的安全性信号。
Objective To analyze specifications related to quality in ICH E2B(R3) guidelines and to find out about the data quality requirements of individual case safety reports. Methods Data elements in the ICH E2B(R3) guidelines were associated with human cognition. The whole process from data, information, knowledge and finally to wisdom was analyzed and demonstrated before factors and visual dimensions that affected data quality were determined. Results Data quality was embodied in data integrity(data dimension) and data accuracy(granularity). The requirements on data relationships and data elements in E2B(R3) guidelines could effectively guarantee the quality of individual case safety reports. Relevant design based on E2B(R3) guidelines could deliver high-quality data on drug safety. Conclusion When designing the safety information collection form, the marketing license applicant and MAH need to ensure data quality from the perspective of accuracy and integrity according to the ICH E2B(R3) implementation guidelines. High-quality data can be accumulated in the safety database to discover potential drug safety signals.
作者
万帮喜
余丽娜
徐菊萍
WAN Bangxi;YU Lina;XU Juping(Jiaxing Taimei Medical Technology Co.,lTD.,Shanghai 200233,China)
出处
《中国药物警戒》
2019年第10期597-601,共5页
Chinese Journal of Pharmacovigilance
基金
国家药品不良反应监测中心资助项目(2018IX001):E2B数据标准研究
