Clinical Trials: new Document for public Consultation

The European Commission has published a public consultation document:

Draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ('CT-3')

This draft is a revision of the existing detailed guidance of the Commission on adverse reaction reporting, including SUSAR reporting. This initiative is a response to many calls from stakeholders during the public consultation on the functioning of the Clinical Trials Directive for short-term improvements/clarifications of the detailed rules for safety reporting. These improvements have to be necessarily limited to what is possible under the current legal framework. The revision of the Clinical Trials Directive is a medium/long-term project, conducted in parallel to this public consultation and aiming at more structural improvements of the situation for investigators and sponsors. The public consultation document is available here. Contributions should be sent by e-mail to sanco-pharmaceuticals@ec.europa.eu by 10 September 2010 at the latest.

Once published, this document will replace the following documents:

  • Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use;
  • Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module); and
  • Questions & Answers specific to adverse reaction reporting in clinical trials.

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