Not A Smooth Ride: How One Of The First Studies Navigated The EU Clinical Trial Portal
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.
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EU regulators have issued a new Q&A document on the key aspects that sponsors of complex trials should consider when making new submissions or moving ongoing studies to the Clinical Trials Information System.
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.
The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval. Problems that some users have experienced while using the system voluntarily are being fixed, according to the European Medicines Agency.