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EudraVigilance Database Management System (DBMS)
The EudraVigilance Database
Management System (EVDBMS) is the core element of the European pharmacovigilance
database. The web-based information system is designed to handle
the safety report information in full compliance with the ICH specifications
featuring:
- A fully integrated organisation and user
management in the EudraVigilance community synchronised with the EudraVigilance
Gateway profile management,
- A fully automated safety and message processing
mechanism, using XML-based messaging, supporting both asynchronous
data interchange and interactive transactions,
- A large reference pharmacovigilance database
that is built by importing and consolidating data from multiple sources,
including information on medicinal products and adverse reactions,
- Extensive query and tracking/tracing capability,
both from scientific and administrative business perspectives.
The EudraVigilance Database Management System consists
of two modules:
- The EudraVigilance Clinical Trial Module
(EVCTM), designed to receive ICSRs related to reports on suspected
unexpected serious adverse reactions (SUSARs) that occur in the frame
of interventional studies;
- The EudraVigilance Post-Authorisation Module
(EVPM), designed to receive ICSRs related to spontaneous reports
and reports from non-interventional studies.
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Last update: Monday, 29 May 2006. |
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