Preparing Your Organization for CTCAE Automation

Introduction: Readiness Comes Before Tools

Successful CTCAE automation begins long before software selection. Organizational readiness determines whether tools succeed or fail.

Preparation is strategic, not technical.

Assessing Documentation Practices

Teams should review how adverse events are currently documented. Are onset, severity, and functional impact captured consistently? Gaps here will limit automation effectiveness.

Aligning Stakeholders Early

Clinical, research, IT, and compliance teams must align on goals and constraints. Misalignment leads to stalled deployments and frustration.

Piloting With Purpose

Small pilots focused on specific regimens or clinics allow teams to learn without excessive risk. Feedback loops should be explicit and rapid.

Building for Sustainability

Automation is not a one-time project. Ongoing governance, monitoring, and training ensure that benefits persist.

Prepared organizations use automation to strengthen safety culture, not replace it.