This document aims to provide an overview of tools for measuring and improving the quality of reports in national adverse drug reactions (ADR) databases and to encourage European Member States to use these tools in their databases. Continuously monitoring and improving the quality of reports ensures that better quality data enters the next step of the pharmacovigilance (PV) process, i.e. signal detection.
What does this document cover?
2. SCOPE survey results
3. Procedure for monitoring and improving the quality of reports in National ADR databases
- Case study: MHRA procedure for monitoring and reporting on ADR data quality in the PV database
- Checklist for defining internal procedure for quality review of ADR data in a PV database
4. Supplementary tools
- EudraVigilance feedback report
- VigiGrade completeness score
- Clinical documentation tool.
The target audience is primarily pharmacovigilance staff working at EU National Competent Authorities.
29 page pdf
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