Heads up, researchers, sponsors, and clinical trial professionals!
The European Commission has updated key guidance documents within EudraLex Vol 10 (March 2024). Here's a summary of the changes to ensure your EU clinical trial journey remains compliant.
Key Updates for EU Regulatory Compliance
"Clinical Trials Regulation (EU) No 536/2014 in Practice" (Version 5)
This revision aligns with the latest Clinical Trials Coordination Group (CTCG) best practices for naming clinical trial documents. This simplifies document management and clarity for all involved. You can find it here.
"Guidance for the Transition of clinical trials from the Directive to the Regulation" (Version 5)
This update reflects recent agreements by National Contact Points (NCPs) and supersedes Chapter 11 of the previous Q&A document. It provides the most current information for transitioning ongoing trials from the Directive to the Regulation. You can find the guidance here.
"Questions and Answers Document" (Version 6.8)
One of my favourite guidance documents has been updated as well. Minor revisions address specific questions regarding Investigational Medicinal Products (IMPs) and Good Laboratory Practice (GLP). Additionally, some national authority contact details have been updated. You can find it here.
Staying informed about these updates ensures your clinical trial adheres to the latest EU regulations, facilitating a smoother approval process. Remember, accurate information is key to a successful EU clinical trial.
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