Before implementing CTCAE v6 , know what changes and where it matters.
A terminology change can propagate through an entire study workflow.
CTCAE terminology and grading can be reflected across study specifications, eCRFs, EDC configuration, mappings, clinical safety processes, testing and downstream documentation.
The challenge is identifying which changes matter in the relevant study and system context, before teams modify too much, too little or too late.
- 01
Which CTCAE v6 changes are actually relevant to our studies and systems? - 02
Where do those changes propagate into forms, mappings, configuration or workflows?
- 03
What needs to change, what can remain as is and what should be tested before go-live ?
The objective is not to rewrite your systems. It is to identify what matters before implementation begins.
- Change
CTCAE v6 change - SpecificationStudy / safety specification
- Data captureeCRF · EDC · mappings
- WorkflowClinical safety workflow
- ActionImplementation / testing
Not every change affects every layer. The assessment follows only the touchpoints relevant to the agreed scope.
CTCAE v6 Readiness Brief
Relevant changes
Impact view
The documents, forms, configuration points, mappings or workflow touchpoints affected by those changes.
Priority actions
What requires update, clarification or implementation review and what can remain unchanged.
Test cases
Prioritised synthetic cases for relevant grading, data capture or workflow changes where testing is included in scope.
Impact assessment · terminology & mapping review · eCRF / EDC review · priority action list · synthetic test cases where applicable
Change what needs changing. Leave the rest alone.
- Terminology & gradingRelevant changes in adverse-event terms, definitions and grade criteria.
- Mappings
Relevant v5.0 → v6.0 term and grade relationships and their implications for existing materials. - Data captureeCRFs, EDC specifications or study documents that reference affected CTCAE content.
- Clinical safety workflowOperational touchpoints where terminology or grading changes affect review, data handling or downstream processes.
Useful before CTCAE changes reach production.
- Before a new study build
When CTCAE v6.0 is being incorporated into a new protocol, eCRF or EDC specification. - Before updating existing templatesWhen reusable study or clinical safety materials need to be reviewed against v6.0.
- Before configuration goes liveWhen terminology, grading or mapping changes are moving from specification into implementation.
- When teams need one agreed impact viewWhen clinical, data management, safety and implementation teams need a shared, prioritised view of what changes.
Defined scope. Existing materials. Actionable output.
- You provide
The relevant materials within scope, for example CTCAE-related study specifications, eCRFs, mappings, EDC documentation or clinical safety workflow materials. - We agree
Studies, systems, documents, scope, deliverables, timing and fee before the review begins.
- We deliver
A CTCAE v6 Readiness Brief with relevant impacts, prioritised actions and test cases where included in scope.
No for a standard readiness assessmentpatient-level data required- Existing study / system materials
- Defined scope
- NDA · data processing agreement where applicable
- Fixed scope and fee agreed upfront
Clinical Operations · Clinical Data Management · Clinical Safety / Safety Operations · Oncology biotech study teams · CRO / implementation teams where relevant