Why Data Lineage is the New Data Integrity

Data Integrity (ALCOA+) has always been the gold standard. But in an era of ePRO, wearables, and direct-to-patient shipping, Data Lineage has emerged as the critical new frontier.

The Disconnected Ecosystem

A typical Phase III trial now involves:

• EDC (Medidata/Rave)
• eCOA/ePRO Vendor
• Central Lab
• IRT/RTSM
• Wearable Device Cloud

When a risk signal fires—say, a "Lost to Follow-up" flag—it often originates in one system but needs to trigger actions in three others.

Mapping the Flow

Without a clear map of data lineage, you are flying blind. If a patient withdraws consent in the ePRO app, does that update the EDC? Does it stop the drug shipment in IRT?

The Vector Approach

We believe in "Systemic Integrity." We map the API handshakes and data transfer specifications (DTS) to ensure that truth in one system is truth in all systems.

1. Source of Truth Definition: Clearly defining which system owns which data point.
2. Integration Validation: Testing the pipes, not just the buckets.
3. Automated Reconciliation: Using scripts to catch drift between systems instantly.