Common Terminology Criteria for Adverse Events

CDISC-Gloss – Standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. NOTE: CTCAE is often used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. [After NCI]