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 EMEA, 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 1st 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, which are published in the website of the DG Enterprise and Industry and in this website.

A sponsor should prepare for the electronic reporting of SUSARs to EudraVigilance as follows:

• Obtain a EUDRACT number from the EUDRACT for all clinical trials, which have been/are initiated in the Community on 1st May 2004 or thereafter.
• Provide the EMEA with a written plan on how the company is going to implement the electronic transmission of ICSRs to the Agency and national Competent Authorities in the EEA. Please address your plan to the attention of Ms Sabine Brosch (sabine.brosch@ema.europa.eu) or Mr. Francois Maignen (francois.maignen@ema.europa.eu), EMEA, Sector Pharmacovigilance and Post-Authorisation Safety and Efficacy, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom.
• Follow the detailed instructions outlined in ’10 Steps to Implementation’, where the procedure for the initiation of the electronic transmission of ICSRs is described.
• Register with EudraVigilance (see ‘How to register’ with EudraVigilance). 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.
• Provide the required IMP information for the EudraVigilance Medicinal Product Dictionary.

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 7.0’

To support the implementation of Directive 2001/20/EC, EudraVigilance has been extended to include the EudraVigilance Clinical Trial Module as of 1st May 2004, which allows for 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 EV WEB (a web based tool for reporting individual case reports) can be done when the marketing authorisation holder fulfils criteria, which are given in the EV WEB section. In general this is used by smaller companies having a small number of cases. EV web can also be used as a transitional measure.

If you require more information about EVWEB please refer to EudraVigilance Web Reporting Application.

Please consult the relevant sections on this website to obtain further information:

You can also contact the EudraVigilance info- and help line of the EMEA at 44 (0) 20 7523 7523 or at eudravigilance@ema.europa.eu.

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Last update: Wednesday, 30 November 2011.