Summary
In this eBook we have merely scratched the surface of ICH E6(R3) and the changes and impact that it will have on the clinical trial landscape.
The need for appropriate strategies for data retention will only increase
Even regarding retention, we haven’t explored the new principle of ‘risk proportionality’ and how it should be applied to long-term retention – this is something we would be keen to cover in a future separate content piece if there is sufficient interest. What I hope this eBook has achieved, is to help organisations to highlight and navigate some of the new guidelines.
Although I don’t foresee major changes to the draft document published earlier this year (and the finalised one due to come by the end of 2024), for many, this will be a continuation of the evolution and digital transformation of clinical trials across the globe.
If you would like to speak to the Arkivum team about anything covered in this guide, please either email us hello@arkivum.com or contact via our website here.
The update to ICH E6 (R3) has expanded the guidance beyond documents to all essential records and data
Further Reading:
eBook: Guide to selecting an external archiving supplier
If you’re interested in finding out more about how to start the process of selecting an partner to support you with your data retention requirements, we recently published the eBook: A Guide to Assessing Third-Party Archiving Solutions.
Access the guide below.
About the eBook
Choosing a third-party archiving solution can be a difficult process as there are many factors and influences involved. Each organisation is different, with different requirements, different sizes of teams, and different levels of internal expertise and knowledge. This can mean that multiple stakeholders are to be considered in the process of selection to ensure they have access. What’s more, in the pharmaceutical industry, data integrity, security, and compliance are paramount. Therefore, making informed decisions about a digital archiving vendor is crucial.
The overarching objective of this guide is to provide a structured framework that allows organisations to evaluate potential third-party archiving solutions based on their specific requirements.
In utilising this guide, organisations can ensure they select a solution that aligns with their unique needs while mitigating risks and maximising the long-term preservation of their valuable data.
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