Good Clinical Practice guidelines require clinical trial documents to be kept for at least two years after the last marketing application approval in an ICH region. These documents may need to be stored longer if regulations or the sponsor require it.
The EU Clinical Trial Regulation (CTR) 536/2014 demands that the content of the clinical trial master file be archived for a minimum of 25 years after the trial ends. This ensures compliance with new regulations and helps preserve important data for future research and checks.
The main challenge is managing and storing large amounts of data effectively, ensuring it’s easy to retrieve and complies with strict regulatory standards. You should keep it locked for editing, but accessible.
Flex Databases offers a solution for these archiving needs. It’s a secure, compliant, and user-friendly system that helps organize and store all trial documents easily and securely.
The advantages of using Flex Databases for long-term archiving include:
We don’t just meet regulatory requirements; we help you maintain compliance and be ready to demonstrate that you are compliant in the event of inspections in the most efficient way.
If you want to learn more about Flex Databases eTMF – send us a request via the form on top of the page or reach out to bd@flexdatabases.com
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