Information for Commercial Sponsors of Clinical Trials
The reporting of suspected unexpected serious adverse reactions (SUSARs) during clinical trials is defined in the Community legislation. This process involves investigators, sponsors of clinical trials conducted in the EEA, the EMA, National Competent Authorities (NCAs) and Ethics Committees.
The reporting is applicable to all investigational medicinal products (IMPs), which are studied in the frame of interventional clinical trials conducted in the EEA and includes all SUSARs, which occur either within or outside the EEA.
With effect from 1 May 2004, the electronic reporting of SUSARs has come into force. The legal basis for this requirement is provided in Directive 2001/20/EC and the implementing texts. See the European Commission's website for further information.
A sponsor should prepare for the electronic reporting of SUSARs to EudraVigilance as follows:
- Obtain a EUDRACT number from the EudraCT database for all clinical trials which commenced in the Community from 1 May 2004, and which also includes clinical trials linked to European paediatric drug development.
- Register with EudraVigilance (see section ‘How to register’).
Please note that a MedDRA license is required for electronic reporting of ICSRs. For further information on the EudraVigilance MedDRA Licensing Policy, please refer to MedDRA licensing Policy in this website.
The business requirements for the electronic reporting to EudraVigilance are described in the Note for guidance for processing of safety messages and individual case safety reports related to EudraVigilance Human version 7.1.
To support the implementation of Directive 2001/20/EC, EudraVigilance was extended to include the EudraVigilance Clinical Trial Module on 1 May 2004, to allow the electronic reporting of SUSARs that occur during clinical trials in accordance with Community legislation. The reporting rules of SUSARs are further described in Reporting Rules of SUSARs to EudraVigilance for commercial and non-commercial sponsors of clinical trials conducted in the EEA.
Reporting through the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB), which is a web based tool for reporting of individual case reports, can be achieved when a sponsor of a clinical trial fulfils criteria given in the EVWEB section.
If you require more information about EVWEB please refer to EudraVigilance Web Reporting Application.
Please note that the EVWEB application currently only supports Internet Explorer 8. If you cannot use this older version of IE, you can still use EVWEB with IE9 & IE10 using the link here to access the XHTML version of the application directly. You will need to set your IE browser to compatibility view. More information on how to change Internet Explorer compatibility view settings is available from the Microsoft website.
See the Agency's website for further information.
Last update: Tuesday, 12 August 2014.