Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU

New Template Issued To State Compliance With EU Data Protection Legislation

Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.

 Young businessman working on a virtual screen of the future and sees the inscription: Clinical trial
Some EU member states insist on the use national templates by trial sponsors • Source: Alamy

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