Who changed a value, when, what it was before, what it is now, and why. Capture records all five automatically, on every record, and none of it can be edited from the app.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
5
things logged: user, time, old value, new value, reason
Field
level, not just form-level
0
admin settings that can turn it off
EDC + eConsent
one audit trail across both
What gets recorded
A usable audit trail needs more than a timestamp. Capture logs the user, the exact time, the value before the change, the value after, and the stated reason, for every field, automatically, with no extra step for the site to remember.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
In practice
A monitor checks who resolved a query, what the value changed to, and the stated reason.
A data manager traces an outlier back to when it was entered and whether it was ever corrected.
QA pulls a sample of entries ahead of an inspection to confirm ALCOA+ principles hold up.
A coordinator fixes a transcription error and records the reason at the moment they do it.
Working together
The audit trail records what happened. Edit checks catch a problem before it is saved as final, then log the query and its resolution in the same trail.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
The difference
A record of every change made to trial data, capturing who made the change, when, the value before and after, and the reason. It replaces the need to trust an unverified correction.
Field-level. Each individual field keeps its own history of old value, new value, user and reason, rather than one log entry for the whole form.
No. The audit trail is recorded by the system, not the interface, and cannot be edited or cleared from the application by any role.
Yes. Signature events, document versions and consent status changes are logged in the same audit trail as eCRF data changes.
Yes, at any time, filtered by site or date range, without needing to file a support request.
Version history usually shows that a document changed. A field-level audit trail shows exactly which value changed, what it was before, who changed it, and why, on every individual field.
Keep exploring
21 CFR Part 11 compliance checklist
The regulation the audit trail is built to satisfy.
ALCOA+ data integrity checklist
The principles a good audit trail supports directly.
Electronic signatures for clinical trials
The signature events that appear in the same audit trail.
CRF builder for clinical trials
Where edit checks and auto-queries are configured.
eCRF software
The data entry screens the audit trail sits behind.
eConsent software
Consent signing, sharing the same audit trail.
Free sandbox, sample data, no credit card. Make an edit and see exactly what gets logged.