- Yes I agree this would be a configurable option (?set within the XLSForm as part of including the audit line so that the form designer has control over this?)
1a) Could the log be encrypted? We do this with our clinical datasets now because of these issues and also GDPR regulations within the EU
- If I understand this correctly your point is that if say multiple fields are on the same screen
Age:
Height:
Weight:
That if I enter age, move to the height field on the same screen and then go back and change Age that this would not be tracked.
But if I moved on to the next screen
Sex:
Marital Status:
And then went back to the Age/Height/Weight screen and amended the data this would be tracked?
I think that would be fine.
Below are actions I think should be tracked:
Minimum:
A)
User exits form either part way through (clicking save changes) or at the end of the form but does not mark form as finalised (save changes)
User reopens that saved form and goes back to any data entry field and amends it
This type of change should be tracked
(Note we use encryption so once they mark the form as finalised we block editing)
Ideal
B)
User is on a screen and enters the age
They move on to the next data entry screen
They then go back to the age screen (without exiting the form) and amend the age
Ideally this should also be logged
For comparison
I was just playing with REDcap which is broadly considered to be GCP compliant so I can see what kind of audit trail that maintains.
It maintains something equivalent to scenario A outlined above - that is if I complete a whole record on Redcap, mark it as saved, re-open and amend a value it can clearly show me that change.
