Do you need character level audit trails in eSource applications?
Probably not.
Almost certainly not.
Definitely not.
Pick the answer that best suits your appetite for risk.
I have worked with customers selecting eSource solutions for early phase trials, with very specific requirements of the audit trail.
This requirement is presented as a need for a system to audit (record) every keystroke, and by implication every change or correction you make whilst entering data - such as backspacing and correcting your own typos. Essentially the application would be required to act as a ‘keylogger’.
The requirement has been presented as a European Medicines Agency (EMA) regulation.
Somewhat unhelpfully, it is very vague as to which regulation.
I asked some smart people, and now believe that the customer must be talking about the guideline adopted in March 2021 by the Good Clinical Practice Inspectors Working Group (GCP IWG) of the EMA — Guideline on computerised systems and electronic data in clinical trials.
I have reviewed it before and felt it was all fairly sensible stuff. Slightly (very and understandably?) biased towards larger multisite, later phase trials (II-III).
I am not going to claim I re-read every word of all 52 pages, but this snippet in §6.2.1 looked applicable…
From §6.2.1 of Guideline on computerised systems and electronic data in clinical trials.
This makes sense - field level audit.
What is not specified is when audit must start.
Early Phase software applications I have worked with will commence auditing (recording a history of changes, namely ‘specifying what was changed (field, data identifiers) by whom (username, role, organisation), when (date/timestamp) and, where applicable, why (reason for change)’) once the form has been committed or saved by the user.
From that time, the data is fully audited at the field level.
I think that meets both the spirit and recommendation of the guideline.
Would love to hear from you if you know differently.
Photos by Andrey Metelev on Unsplash
And Nathaniel Shuman on Unsplash
