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