VigiFlow www.crtutor.com Computer software for management of ADR case data Magnus Wallberg UMC
Background • 2001 – the cooperation between SwissMedic (IKS) and the UMC was started • First idea – store the reports directly in the UMC database • A project was started – ADR Pilot • Version 1 – Summer 2003 – Tightly connected to the WHO database – Built on the WHO database architecture
Important features • Web based – no client requirements • Built according to E2B standard • Built in error handling • Built in support for several languages
Important features • Complete audit trail on all fields • Standardized output (on html and pdf format) – Summary tabulations – CIOMS line listings – E2B export (for sending or local storage)
• Compatible with WHO-ART and MedDRA
Important features • Designed to handle: – Several organizations – Several organization levels • Primary notifier • Regional Centre • National Centre
• Maintained according to GxP
Flow of ADR report
Where are the reports stored
Static demonstration • Showing the possibilities of VigiFlow – – – – –
How to enter a report Dictionary search functions Printouts of reports Search and Statistics Output of search results
Advantages I (general aspects) • • • • • •
Less delay in ADR reporting Possibility to connect help texts to each field Mandatory fields Error checks Usage of lexicons for data entry Live access to updated terminologies – WHO Drug Dictionary – WHO-ART / ICD-10 – MedDRA
Advantages II (technical) • • • •
One server installation maintained in Uppsala No client installation Unlimited number of users Sharing of cost and ideas – Development – Maintenance
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Total number of reports
VigiFlow Statistics VigiFlow
1200
1000
800
600
400
200
0
Note! Switzerland has entered 29083 reports!
What’s in the pipeline • Near future – Extended search and statistics – E2b import
• Next steps – EMEA/FDA connection – Basic entry tool for companies
• Further in the future – Visualization tools for reports and statistics – Duplication detection tool