New guidelines to address clinical trial opportunities and challenges

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 will focus on extracting some of the key content related to the retention of clinical trial records and data.

Click on the button below to start reading about the new guidelines.