Attributable, Legible, Contemporaneous, Original, Accurate, and the plus: Complete, Consistent, Enduring, Available. Here is what each one means and where Capture supports it.
Free sandbox · No credit card · 21 CFR Part 11 aligned
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.
9
ALCOA+ principles
1
audit trail that covers all of them
0
overwritten values, ever
Always
exportable audit history
The nine principles
Inspectors use this list to judge whether trial data can be trusted. Here it is in plain language.
Tied to the specific person who entered or changed it.
Readable and permanent, not a value that can quietly disappear.
Recorded at the time the activity happened, not days later from memory.
The first record, or a verified copy, with nothing overwritten.
Correct and a true reflection of the observation made.
Nothing missing, including repeated measurements and reruns.
Recorded in the expected, chronological sequence.
Preserved for as long as the retention period requires.
Retrievable for review or inspection throughout that period.
Attributable + Contemporaneous
A value entered under a shared login, or added days after the visit, fails both principles at once. Capture logs the signed-in user and the exact timestamp on every entry and every edit, automatically.
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
Original + Accurate
When a site fixes a transcription error, the fix should not erase what was there before. Capture keeps the old value next to the new one, with the reason for the change, so the original entry is never lost.
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.
Complete + Consistent
Missing data and out-of-sequence entries are two of the most common findings in a data-integrity review. Skip logic and the visit schedule keep entries complete and in the order the protocol expects.
| Analyte | Result | Unit | Ref. range |
|---|---|---|---|
| Haemoglobin | 13.8 | g/dL | 13.0 to 17.0 |
| White blood cells | 6.2 | 10^9/L | 4.0 to 10.0 |
| Platelets | 412 | 10^9/L | 150 to 400 |
The difference
Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring and Available. It is the framework inspectors and monitors use to judge whether clinical trial data can be trusted.
No. It is a widely referenced data-integrity framework used in GCP guidance and inspection practice, not a standalone regulation like 21 CFR Part 11. A strong audit trail tends to satisfy most of both.
Corrections do not overwrite the original entry. The audit trail keeps the old value, the new value, who made the change, when, and the stated reason.
Legible means the record is readable and permanent right now. Available means it can still be retrieved and reviewed years later, for as long as the retention period requires.
Yes. The same principles apply to any electronic trial record, including patient-reported outcomes and signed consent documents, not just CRF data.
Keep exploring
21 CFR Part 11 compliance checklist
The FDA regulation that overlaps heavily with ALCOA+.
Audit trail software
The mechanism behind most of these principles.
CRF builder for clinical trials
Edit checks and calculated fields that keep data accurate.
ICH E6(R3) guide
The GCP guideline that references data integrity directly.
eCRF software
Where these controls show up during data entry.
Electronic signatures for clinical trials
Attributable, verified signing for consent documents.
Free sandbox, sample data, no credit card. Check every principle yourself.