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.
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The European Commission says it is keen support harmonization of national requirements under the EU Clinical Trials Regulation and wants to explore how the so-called part II templates have helped on this front and whether new ones are needed.
The EU guideline on the Clinical Trials Regulation has been updated with a list of member state websites where sponsors can find information on national requirements for trial applications.
From grappling with a never-ending list of conflicting national requirements to dealing with numerous technical issues, a research project manager at Norway’s Oslo University Hospital talks about the hiccups faced by their multinational COVID-19 platform trial that was among the first studies submitted for approval under the EU Clinical Trial Regulation.