Modern clinical trials generate vast streams of transactional data, yet raw audit logs fail to give sponsors the clarity regulators demand.

Under ICH E6(R3), ultimate accountability for trial data integrity remains squarely with sponsors, even for data generated by third-party systems like Randomization and Trial Supply Management (RTSM).

However, traditional audit trails present a major hurdle. Unstructured database dumps capture every micro-level background query, shifting the burden onto sponsors to decipher technical logs rather than evaluating true clinical risk.

The core issue? Technical completeness is not the same as clinical legibility.

When a single site action creates dozens of system events across scattered data structures, sponsor oversight requires a clear lens to reconstruct clinical intent and ensure inspection readiness.

In this white paper, 4G Clinical explores:

• How ICH E6(R3) redefines sponsor accountability and supplier expectations
• The operational pitfalls of treating raw audit exports as proof of oversight
• Methods for transforming complex system activity into structured, risk-focused audit views
• How supplier-led verification and validated reporting strengthen overall data governance

For teams managing third-party systems or preparing for regulatory inspections, this paper outlines a practical path toward meaningful, risk-based data oversight.