A Guide to EU GCP Data Management Regulations - Arkivum

eTMF & GCP Data / 02 Nov, 2021

A Guide to EU GCP Data Management Regulations

A complete guide to navigating long-term EU GCP data regulations and corresponding solutions.

Working within the regulated field of clinical trials can be challenging, especially when contending with regulatory changes.

In January 2022, Regulation 536/2014 will become a central European law, bringing with it a raft of new regulations impacting long-term data management, such as the requirement to retain the TMF for a minimum of 25 years.

Keeping atop of the new requirements and understanding what their impact is upon your organisation can being challenging. You could even be at risk of non-compliance.

That’s why we’ve created this simple guide to the key regulations related to the management of long-term clinical data and helped to articulate what these mean for you from a data management perspective.

You can download our EU regulation and storage comparison guide for free by completing the below form.



If you would like to speak to one of our team, please do not hesitate to contact us by emailing Hello@Arkivum.com or visiting www.Arkivum.com/contact.

 

Whitney Armstrong

Whitney is the Marketing Executive at Arkivum. She joined the business in 2020 and is responsible for supporting marketing campaigns and activities targeting key sectors. Whitney has over 5 years' experience of delivering and supporting marketing strategy for technology brands.

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