eBook: ICH E6(R3): What does the new guidance say about record retention?
New eBook exploring what ICH E6(R3) covers about record retention and it’s impact on the management of essential records and data within clinical trials.
2024 sees the publication of the latest version of ICH E6, with the R3 (revision 3) version improving on the previous 2nd iteration (R2).
The update, initially endorsed back in 2019, aims to modernise the guidelines and equip stakeholders across the clinical trial landscape with current good practices to face the challenges presented today. As stated on the ICH website, the new guidelines seek to address:
“…the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.”
The finalised draft guidelines of ICH E6(R3) cover a broad range of topics. For the purposes of this eBook (and in the context of the Arkivum community), we have focused on extracting some of the key content related to the retention of clinical trial records and data. This includes:
- The change of terminology and it’s impact on retention
- Updated retention good practice guidance within ICH E6(R3)
- Other important considerations including the management of inventories, the use of computerised systems and more.
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Tom Lynam
Tom is the Marketing Director at Arkivum. He joined the business in January 2020 tasked with driving new business growth and building the brand into new sectors such as Pharmaceutical and Life Sciences. He has over 12 years’ experience in several diverse marketing leadership roles across technology and professional services organisations.
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