Auditability and Traceability in CTCAE Workflows

Introduction: Reconstructing the Past

In oncology trials, the ability to reconstruct how a decision was made is as important as the decision itself. Auditors, sponsors, and regulators routinely ask not just what grade was assigned, but why.

Auditability is therefore a first-class requirement in CTCAE workflows.

What Auditors Actually Look For

Auditors seek traceability: a clear line from patient data to final reported grade. They want to see source documentation, applicable CTCAE definitions, reviewer identity, and timestamps. Gaps or ambiguities raise red flags.

Manual workflows often struggle here, relying on memory or scattered notes to explain past decisions.

Automation as an Audit Asset

When designed properly, automation can improve audit readiness. Systems can automatically capture which evidence supported a suggested grade, when it was reviewed, and how it was modified.

This creates a durable record that does not depend on individual recollection.

Avoiding the Black Box Problem

Auditability collapses if automation behaves like a black box. If users cannot see how outputs were generated, they cannot defend them. Transparency is not optional; it is essential.

Every suggested CTCAE event should be accompanied by its rationale, visible and reviewable.

Building Confidence Through Traceability

Traceable workflows benefit everyone. Clinicians gain confidence that their decisions are defensible. Sponsors receive cleaner data. Regulators see a system that takes safety seriously.

Auditability is not a burden; it is a signal of maturity.