Entering The Post-Paper Realism: The Shoulds & Shouldn'ts Of Electronic Systems & Clinical Trials Data

By Marcin Hernik

With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618 instances), in this blog, we will catch a glimpse of the multitude of visions the EU GCP Inspectors Working Group have on how to avoid the dystopian future of a paperless world in their long overdue, and at last finalised, Guideline on computerised systems and electronic data in clinical trials.

The new guideline comes into effect on Sept. 10, 2023—six months after publication, replacing their Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.