Clinical Data Lab
A hands-on demonstration of clinical data review—from study oversight and EDC logic to external-data reconciliation, QC and database-lock readiness.
STUDY-001
Phase II · Randomized · Double-Blind · Placebo-Controlled · Synthetic
| DATA STREAM | STATUS | ISSUES |
|---|---|---|
| EDC | ACTIVE | 7 |
| Central Lab | REVIEW | 3 |
| ePRO | REVIEW | 6 |
| Safety | RECONCILED | 0 |
Oversight before action.
A CDM needs visibility across completeness, queries and external data before declaring a study lock-ready. Use the navigation to inspect individual workflows.
DEMO-001
| VISIT | STATUS | DATA SIGNAL |
|---|---|---|
| Screening | COMPLETE | All expected forms |
| Baseline | COMPLETE | Lab reconciled |
| Day 7 | REVIEW | 1 ePRO form missing |
| Day 14 | UPCOMING | Not yet expected |
Trigger an edit check.
Change Visit Date to a date before Screening Date.
Visit Date precedes Screening Date. Please review and correct or provide clarification.
THEN RAISE QUERY "Visit Date precedes Screening Date"
EDC ↔ Central Lab
EDC
SUBJID: DEMO-031
VISIT: Baseline
Collection: 09:34
Result: 4.2
MISMATCH
LAB VENDOR
SUBJID: DEMO-031
VISIT: Baseline
Collection: 09:33
Result: 4.2
The result matches, but collection time differs by one minute. Review source/vendor transfer conventions before resolving; do not silently overwrite either source.
1,248 synthetic records.
Ready to validate completeness, chronology, reconciliation and expected-form signals.
Evidence before lock.
| Expected forms reviewed | PASS |
| Safety reconciliation | PASS |
| Medical coding review | PASS |
| External lab reconciliation | OPEN |
| Open query review | OPEN |
The demonstration intentionally remains below 100%: database lock should follow documented completion of required cleaning and reconciliation activities—not a decorative dashboard score.