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
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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
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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
Report editing
Primary reporter
creates report
X
Disk storage
2
Report
status
first
assessment
4
WHO database
Vigibase
final
assessment
6
8
Reports marked for
submission to WHO
are sent to the WHO
database
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
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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)
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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!?
Regional centre
National centre
Web interface
(Logged on as
nat centre user)
Web interface
(Logged on as
reg centre user)
Primary care
HTTPS
HTTPS
Vigibase online
Doctor
Doctor
Third Party
Software
INTERNET
National
database
HTTPS
PMI
Vigibase online
E2b
or
E2b-extract
PMI
SJUNET
Authentication and
secure transmission
via the PMI
infrastructure.
PMI
UMC
Vigibase
database
Description of software
Web server
"App server"
E2b reports
from
other countries
UMC common
server tools
(ErrorHandling,
server variables etc.)
E2b report
(under construction)
Gateway
Active Server Pages
for web logic
The location of this
software is not yet
decided
SOAP
SOAP
Vigibase Online
specific
components
E2b conversion
pipeline
Presentation
Stylesheets
UMC common
"web tools"
(PDF generation,
server variables etc.)
E2b reports
Verification
pipeline
DD,
WHOART...
Vigibase Online
XML database
FTP
Lexicon generation
module
Vigibase
the UMC database
Dictionaries and
lexicons stored in
memory.
Description of hardware
Internet (unsecure)
HTTPS
VigiSearch
Win2000
Internal system (secure)
SOAP (in/out)
FTP (out)
Internet
FTP
ODBC
SOAP (in/out)
FTP (out)
SOAP (in/out)
"Gateway"
FTP (out)
Session control
Authentication
(Linux server)
HTTPS
Vigibase Online
Win2000
Application server
Win2000
Vigibase
"the UMC database"
Thank you for your attention!
[email protected]
[email protected]
[email protected]
http://www.who-umc.org
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Computer software for management of ADR case data