The EMA has published “Guideline on computerised systems and electronic data in clinical trials.”
Anyone familiar with Annex 11 of Eudralex Annex 4 won’t be surprised by the content, but frankly I expect a lot of folks who have primarily experience on the clinical side will be scratching their heads. The fact that the authors felt the need to have an entire paragraph dedicated to unique user names is telling.
This is a great resource for sponsors who need to figure out just what to evaluate at investigators sites, a requirement this guideline repeats multiple times.
I’ll be very curious how effective sponsors are in ensuring this requirement is met “The investigator should receive an introduction on how to navigate the audit trail of their own data in order to be able to review changes.”
Investigations of a Dog 