EudraVigilance (EV)




EudraVigilance Data Analysis System

The EudraVigilance Data Analysis System has been designed to allow users to analyse safety data collected in EudraVigilance in view of allowing better-informed decisions about the safety profile of medicinal products. It provides pharmacovigilance and Clinical Trials departments with a range of analytical tools: from measuring reporting compliance for regulatory purposes, to pharmacovigilance analyses (such as signal detection tools).

The following illustration displays the components of the EudraVigilance Data Analysis System:

Data Collection - Source Systems

This architecture has the following components:

  • Source Systems
  • ETL Process
  • EudraVigilance Data Warehouse
  • EudraVigilance Analysis Toolkit

Source Systems

Source systems capture and store the data that are reported to or used by EudraVigilance. These systems include the EudraVigilance Database Management system (EVDBMS), the EudraVigilance Medicinal Product Dictionary (EVMPD), the EudraVigilance registration database, the Medical Dictionary for Regulatory Affairs (MedDRA) and other internationally agreed standard terminologies used within EudraVigilance (e.g. European Pharmacopoeia Dosage Forms).

The EVDBMS contains the following information on adverse drug reactions, which is used to populate the Data Warehouse: PM-ICSRs: Individual Case Safety Reports transmitted to the EudraVigilance Post-Authorisation Module (EVPM)
  • CT-ICSRs (SUSARs): Individual Case Safety Reports transmitted to the EudraVigilance Clinical Trial module (EVCTM)
  • PSUR-ICSRs: Individual Case Safety Reports from Periodic Safety Update Reports transmitted to the EVPM
  • ASR-ICSRs: Individual Case Safety Reports from Annual Safety Reports transmitted to the EVCTM
  • BACKLOG-PM-ICSRs: Individual Case Safety Reports transmitted retrospectively to the EVPM
  • BACKLOG-CT-ICSRs: Individual Case Safety Reports transmitted retrospectively to the EVCTM

The EVMPD contains information on:

  • Authorised Medicinal Products
  • Investigational Medicinal Products that are or have been studied in clinical trials within the EEA.

The EudraVigilance registration database contains information about National Competent Authorities, Marketing Authorisation Holders, and Sponsors of clinical trials in the EEA that have electronic reporting obligations and are registered with the EudraVigilance system. This information is used to configure data access rights and privileges in the EudraVigilance Data Analysis System.

ETL Process

The extraction, transformation, and loading (ETL) process is the means by which data is transferred from source systems and loaded into the EudraVigilance Data Warehouse. Specifically, the ETL process does the following:

  • Stores information about the structure and contents of source systems and the Data Warehouse.
  • Correlates the source systems structure and contents to the structure and contents of the Data Warehouse.
  • Provides information to the data extraction tools that physically execute the transfer of data from source systems to the Data Warehouse.

The ETL process is done nightly so that every day the EudraVigilance Data Warehouse is populated with updated data from the day before.

EudraVigilance Data Warehouse

The EudraVigilance Data Warehouse is the repository for storing the information required to analyse data from the disparate source systems involved in the EudraVigilance Data Analysis System. Just as the source systems are designed to process capturing and storing data, a Data Warehouse is optimised to allow users to report on and manipulate data. Manipulation of data includes transformation of variables, filtering and tabulation.

EudraVigilance Analysis Toolkit

The EudraVigilance Analysis Toolkit provides many predefined table and graph formats for report presentation. Users can customise formatting to suit particular needs, and have a variety of functions available for the manipulation of report results. For example, users can sort and filter data, add subtotals, create new calculations, change the arrangement of data on a report, and more.

The way users interact with the EudraVigilance Data Analysis Toolkit is through a graphical user interface (GUI), which will be available via a common web browser. The toolkit GUI can change layout, depending on specific Internet browser (i.e. Netscape or Internet Explorer).

A 2 day training course on how to use EVDAS is held 5 times a year at the EMA for members of National Competent Authorities (NCAs).

For upcoming training dates please see the Training section. Experts are kindly requested to register at least 3 weeks before the course starts For any further information, please visit the EMA Service Desk portal

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Last update: Thursday, 28 January 2016.



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