Straightforward But Technical: Transferring Existing Studies To EU Clinical Trial Portal
At a webinar organized by the European Medicines Agency, EU member states discussed their experiences with reviewing the requests made by trial sponsors to switch existing studies to the Clinical Trial Regulation.
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Clinical Trial Regulation: EU Clarifies Requirements For Patient-Facing Documents
An updated Q&A on the EU Clinical Trial Regulation distinguishes between patient-facing documents and recruitment material to clarify in which sections of the trial application these should be submitted. It also underlines the main principles to consider for transitioning studies from the Clinical Trials Directive to the CTR.
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.
Here At Last: A New Era For Clinical Trials In The EU
A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.