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
A regulatory binder is crucial for managing clinical trial documents, it ensures compliance with regulations, and makes audits easier. It helps keep important documents organized and readily accessible for trial monitors, auditors, and regulatory authorities, and serves as a useful reference for the research team. While it’s not legally required, maintaining a regulatory binder is […]
Trial master files (TMFs) are essential for completing clinical studies, but managing TMF content can be very complex. Electronic trial master file (eTMF) systems represent the next step in clinical trial document management and are becoming an integral part of future clinical research. What is an eTMF? An electronic trial master file (eTMF) is a […]
Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial’s timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of […]
Handling a Trial Master File (TMF) can be tough for clinical teams, but it doesn’t have to be. Old systems with outdated file sharing methods or homemade systems with spreadsheets or paper can make managing sensitive trial data risky. Over the past decade, electronic Trial Master File (eTMF) systems have helped many biopharma companies and […]
We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.