Governance Is the Backbone of Safe CTCAE Automation

Introduction: Safety Tools Require Safety Rules

Automation in oncology safety workflows is not simply a technical challenge. It is a governance challenge. Any system that influences how adverse events are identified, graded, or reported must operate within a clearly defined framework of accountability, oversight, and review.

Without governance, even accurate tools become risky. With governance, automation can strengthen safety rather than undermine it.

Why CTCAE Automation Is Governance-Sensitive

CTCAE grading affects clinical decisions, protocol compliance, and regulatory submissions. Errors or inconsistencies are not abstract problems; they can lead to patient harm, trial delays, or audit findings. Unlike administrative automation, safety-related tools cannot be deployed casually.

Governance ensures that automation behaves predictably, transparently, and within agreed boundaries.

Defining Roles and Authority

A core governance question is simple: who has the authority to finalize a CTCAE grade? In a safe system, that authority always resides with a qualified human reviewer. Automation may suggest, prioritize, or summarize, but it does not decide.

Roles must be explicit. Research nurses, coordinators, investigators, and monitors need clearly defined permissions and responsibilities. Ambiguity here is a common source of risk.

Oversight, Review, and Escalation

Governed systems include mechanisms for periodic review. Discrepancies, overrides, and edge cases should be sampled and discussed. Patterns of disagreement can signal training needs or logic gaps.

Escalation pathways matter. When a suggested grade conflicts with clinical intuition, users must know how to flag and resolve the issue without slowing care.

Change Control and Versioning

CTCAE automation logic evolves over time. Governance requires formal change control: documentation of updates, validation on representative data, and communication to users. Silent changes erode trust and complicate audits.

Governance is not bureaucracy. It is the infrastructure that allows innovation to operate safely in high-stakes environments.