VigiFlow is a web-based Individual Case Safety Report (ICSR) management system that is specially designed for use by national centres in the WHO Programme for International Drug Monitoring.VigiFlow is based on and compliant with the ICH E2B standard and is a trademark of the UMC and maintained by the UMC in Uppsala, Sweden.
ICSR data can be manually entered into VigiFlow with support from the latest versions of terminologies such as the WHO Drug Dictionary and WHO-ART or MedDRA. Some fields are mandatory, and this, together with built-in error checks, helps users to add data correctly. It is also possible to import ICSR data as XML files in the E2B format. If a country has regional pharmacovigilance centres, the manual entry of ICSRs can be done at this level.
It is easy to communicate within VigiFlow by adding a digital ‘post-it’ note to the ICSR. This note will stay with the report when it is sent from a regional centre to the national centre or while different people at the national centre work on the report.Once a report is complete and committed the first version of the ICSR is considered to be finalized. It is easy to retrieve reports to amend the contents or add follow-up information. An audit trail on each report will keep copies of earlier versions and show which user added new information.
A search and statistics module is part of VigiFlow; both line listings and statistical tools are among the profiles available. The results can be exported in different output formats, either as PDF files or in spreadsheet format compatible with Microsoft Excel.
ICSR data can be sent to external contacts such as companies or other regulatory agencies either as PDF files (as computer files or hardcopy printouts) or in E2B formatted XML files. The submission manager in VigiFlow will keep track of which ICSRs should be sent to an external contact and which have already been sent. All imported E2B files are also tracked.ICSRs will automatically be flagged for being copied to VigiBase, the WHO Global ICSR database when they are committed; however, national centres can easily remove this and thereby keep a specific report private.
Since VigiFlow works over the internet, no local installations, back-ups or maintenance are necessary. The only requirements are a web browser, preferably Mozilla Firefox or Internet Explorer, and an internet connection. The internet access is encrypted and any information stored in VigiFlow is only accessible by users within the same country/organisation identified by their individual user name and password.
The UMC charges a nominal license fee for full access to the functionality described above. However, a version of VigiFlow with limited access is available free of charge to member countries of the WHO Programme. The functionality not available includes the E2B import and export and the search and statistics module. The free of charge version is not a complete management system and is primarily meant to be used for sending ICSRs to the UMC.
If you want more information or are interested in using VigiFlow, please contact: email@example.com
VigiFlow page last updated 7 May 2013
Uppsala Monitoring Centre · Tel: +46 18 65 60 60 · Fax: +46 18 65 60 88