Clinical Trial Data Reconciliation Is an Evidence Control
Holding
Clinical trial data is not ready for analysis until discrepancies across EDC, laboratory, imaging, and safety systems are resolved or explicitly dispositioned.
Issue
The same participant event may appear in several systems with different identifiers, timestamps, units, or status values. Treating one source as automatically authoritative can hide contradictions instead of resolving them.
Analysis
The practical issue is not only duplicate data; it is uncertainty about which record represents the trial event and why. Unresolved mismatches weaken both analysis and inspection readiness.
Resolution
The system should define source responsibilities, maintain cross-system identity keys, surface discrepancies as controlled issues, and record resolution decisions with timestamps and accountable roles.
Evidence Package
The evidence should show reconciliation rules, discrepancy queues, query history, source snapshots, corrected records, and a final data cut with documented exclusions.
Conclusion
A clinical trial data cut is defensible only when its unresolved differences are visible and governed.