Building Effective CTCAE v6.0 Training Programs for Sites

CTCAE v6.0 will only work as intended if investigators, nurses, and coordinators know how to use it. Structured, role‑specific training is essential to avoid mis‑grading, reduce queries, and protect patients.

Core Learning Objectives for v6.0

Training programs should ensure that site staff can:

• Explain the CTCAE v6.0 grading scale and locate official NCI resources.

• Identify major differences from v5.0, especially in hematologic and lab‑based toxicities.

• Apply v6.0 criteria to common symptom AEs using real‑world case vignettes.

For coordinators and nurses, emphasis should be on practical examples and documentation habits; for PIs, on protocol‑level implications (DLTs, dose modifications, eligibility).

Using Central Resources: NCI and Cooperative Groups

NCI and cooperative groups already provide high‑quality baseline material:

• The official CTCAE v6.0 PDF and Excel files with full term and grading definitions.

• CTCAE v6.0 implementation FAQs clarifying when v6.0 can be used and how it will roll out in NCI CTEP/DCP trials.

• Slide decks like SWOG’s “What’s new in CTCAE v6,” which highlight key changes and practical grading tips.

Site‑oriented training can adapt these into shorter modules tailored to local protocols and workflows.

Designing Role‑Specific Training Paths

Effective programs differentiate by role:

• Investigators: focus on protocol design, DLT definitions, eligibility, and complex attribution scenarios.

• Nurses/CRCs: focus on symptom interviews, documentation language that maps to v6.0 definitions, and lab‑to‑grade workflows.

• Data managers: focus on dictionary updates, version tracking, and query patterns associated with v6.0 adoption.

Short, recurring case‑based sessions often work better than one long didactic lecture.

Measuring Training Impact and Quality

To ensure training works, organizations can track:

• AE query rates before and after v6.0 training, especially for key toxicities.

• Inter‑rater reliability across clinicians for standardized AE vignettes.

• Concordance between CTCAE v6.0 grades and PRO‑CTCAE scores where both are collected.

These metrics can feed back into targeted booster sessions on problematic areas.

Supporting Sites During Mixed‑Version Periods

Sites will often run v5.0 and v6.0 trials in parallel.

Training should:

• Emphasize checking which CTCAE version each trial uses at the start of every clinic or data‑entry session.

• Provide side‑by‑side comparison sheets for key toxicities where version differences are most impactful.

Thoughtful training is one of the highest‑ROI investments sponsors and CROs can make to ensure CTCAE v6.0 delivers consistent, high‑quality safety data.