VigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues.

ABSTRACT:

Background

Individual case safety reports of suspected harm from medicines are fundamental to post-marketing surveillance. Their value is directly proportional to the amount of clinically relevant information they include. To improve the quality of the data, communication between stakeholders is essential and can be facilitated by a simple score and visualisation of the results.

Objective

The objective of this study was to propose a measure of completeness and identify predictors of well-documented reports, globally.

Methods

The Uppsala Monitoring Centre has developed the vigiGrade completeness score to measure the amount of clinically relevant information in structured format, without reflecting whether the information establishes causality between the drug and adver

SUBMITTER: Bergvall T 

PROVIDER: S-EPMC6447519 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature