Data Quality of Individual Case Safety Reports Based on ICH E2B (R3) Implementation Guidelines

doi:10.19803/j.1672-8629.2019.10.06

Abstract

Abstract: 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.

Key words: ICSR, E2B, data quality, safety database

CLC Number:

R951

WAN Bangxi, YU Lina, XU Juping. Data Quality of Individual Case Safety Reports Based on ICH E2B (R3) Implementation Guidelines[J]. Chinese Journal of Pharmacovigilance, 2019, 16(10): 597-601.

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