vigibase online - a web-based tool for adr management magnus wallberg, m sc engineering physics...
TRANSCRIPT
Vigibase Online - a web-based tool for ADR
management
Magnus Wallberg, M Sc Engineering Physics
Helena Sjöström, Pharmaceutical officer
Sten Olsson, Head, External Affairs
Content• Introduction / Background• Description - flow of ADR reports• Advantages I• Demonstration• Important features of the system • Advantages II• Future possibilities• If interest
– Technical description of the system
• Questions
Background I
• WHO report format 1981 –– NC have to comply
– Lack of computer support at many NC
– WHO paper forms accepted
• ICH – E2B format introduced – Harmonization
– Greater complexity
– UMC Vigibase 2002
Background II
• NC choices– System based on international standard-E2b-
or not
– Buy commercial software • Expensive• Not directly applicable
– Develop inhouse• Complicated• Time consuming
Background III
• SwissMedic – HIS -> HIS 2000– Vigibase Online
• Version 1.0 (2003-07-01)– No local database – Uppsala-based xml-database
• Versión 2.0 (2003-11-01)– Built on E2b-standard
– Text based to improve performance
Vigibase Online
• Fully implemented in Switzerland• Used for a year by Ghana as pilot
country• Morocco latest live user • Pilot phase with Swiss company
Description – flow of ADR reports
0
8
WHO databaseVigibase
Primary reportercreates report
firstassessment
finalassessment
Reports marked forsubmission to WHOare sent to the WHOdatabase
Report editing
Disk storage
2
4
6
X
Reportstatus
Advantages I
• Improvement of report quality– Mandatory fields
– Possible to connect help text to each
individual field
– Error checks
• Cut delays in ADR reporting
Advantages I (contin.)
• Live access to latest terminologies;– WHO Drug Dictionary
– MedDRA
– WHO-ART
• Access to experienced co-workers at the UMC
• Integration with VigiSearch
Demonstration (static)
Important features
• Built on E2b standard• Built-in error handling/validation
– adapted dependent on category of user/assessor
• Download to local PC possible• Built-in support for several languages• Tools for statistics and analysis• Complete audit trail on all fields• Performance dependent on speed of
internet connection
Advantages II (technical aspect)
• One server installation• No client installation• Unlimited numbers of users• Sharing of costs
– development
– maintenance
How to get started
• Test site (not for reporting)• Get user’s guide from the UMC• Request national data base to be
established by the UMC. Provide identity of users
• Users receive username & password• Free use of system for 6 months• Annual fee of USD1600 thereafter
The Future
• Same system for several authorities• Facilitate communication• A direct link with other system
– SIGNAL document
– VigiSearch
• Useful (with adaptation) for other types of organizations; – Pharmaceutical companies
• Simple linking to other reporting tools
A complete system!?
PMISJUNET
INTERNETThird PartySoftware
Web interface(Logged on as
reg centre user)
HTTPS
Doctor
Doctor
E2bor
E2b-extract
PMI
PMI
Primary care
Vigibase online
Web interface(Logged on as
nat centre user)
HTTPS
HTTPS
Nationaldatabase
UMCVigibasedatabase
Regional centre National centre
Vigibase online
Authentication andsecure transmissionvia the PMIinfrastructure.
Description of software
Gate
wa
y
DD,WHOART...
PresentationStylesheets
Verificationpipeline
Vigibase Onlinespecific
components
UMC commonserver tools
(ErrorHandling,server variables etc.)
Vigibase OnlineXML database
E2b conversionpipeline
Vigibasethe UMC database
The location of thissoftware is not yetdecided
Active Server Pagesfor web logic SOAP
Web server "App server"
SOAP
Lexicon generationmoduleFTP
E2b report(under construction)
E2b reports
E2b reportsfrom
other countries
UMC common"web tools"
(PDF generation,server variables etc.)
Dictionaries andlexicons stored inmemory.
Description of hardware
Internet
"Gateway"Session controlAuthentication(Linux server)
VigiSearchWin2000
Vigibase OnlineWin2000
Application serverWin2000
Vigibase"the UMC database"
HTTPS
HTTPS
SOAP (in/out)FTP (out)
SOAP (in/out)FTP (out)
SOAP (in/out)FTP (out)
FTPODBC
Internet (unsecure) Internal system (secure)
