what is vigibase?
Post on 13-Mar-2016
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VigiFlowwww.crtutor.com
Computer software for management of ADR case data
Magnus WallbergUMC
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
Report repository
Search and Statistics database
Regional Centre 1 Regional Centre 2
Regulatory Authority
External reporting targets
E2B(XML)
WHO database - Vigibase
Where are the reports stored
WHO database
VigiFlow – search database
Export when committed
Export when "send to UMC"
VigiFlow
"XML-database"
Search StatisticsReport handling(view print ...)Report editing
Only reports that shall be sent to
UMC
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
VigiFlow Statistics
Note! Switzerland has entered 29083 reports!
VigiFlow
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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
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