Information for Sponsors of Non-Commercial 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 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, together with other relevant information, available on the European Commission's website.
For the purposes of registration with EudraVigilance, a non-commercial clinical trial should include the following criteria:

It is not part of a development program for a marketing authorisation of a for-profit organisation.

• It is designed, conducted and reported under the control of the researchers.
• Data issued from the clinical trial are owned by the researchers.

The relevant Commission Q&A document ("Notice to Applicants, Questions & Answers, Clinical Trial Documents, April 2006") states that "Support from industry by providing medicinal products free or at reduced costs or by providing financial or material or scientific support should not be taken to imply that industry is participating in the trials for the purpose of the Commission Directive on Good Clinical Practice, and should not disqualify the trial from being regarded as a non-commercial trial."

A non-commercial 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 also include clinical trials linked to European paediatric drug development.
• Follow the detailed instructions outlined 6 Steps required for the implementation of electronic transmission of pharmacovigilance
• Register with EudraVigilance (see section 'How to register'). Please note that a MedDRA license is required for electronic reporting of SUSARs. Non-commercial sponsors of clinical trials qualify for a EudraVigilance Fee Waiver MedDRA subscription. For further information on the EudraVigilance MedDRA Licensing Policy, please refer to MedDRA licensing Policy in this website.
• Provide the required IMP information in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

To support the implementation of Directive 2001/20/EC, EudraVigilance was extended to include the EudraVigilance Clinical Trial Module on the 1st May 2004, which allows for the electronic reporting of SUSARs that occur during clinical trials in accordance with Community legislation. Sponsors of non-commercial clinical trials conducted in the EEA should ensure that all relevant information about SUSARs are recorded and reported to EudraVigilance, the National Competent Authorities in the concerned Member States and to the Ethics Committees.

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Please consult the relevant sections on this website for further information:

Information for Marketing Authorisation Holders

Information for Commercial Sponsors of Clinical Trials

Information for Sponsors of Non-commercial Clinical Trials

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Last update: Wednesday, 6 July 2016.