Grading of an Adverse Event (AE) is ultimately the responsibility of the Investigator.  Each protocol will have slightly different requirements and use different grading systems.  By being familiar with the different grading systems, Study Coordinators can assist the Investigator to accurately grade Adverse Events, ensuring consistency across the study (and less queries from Data Management).

AEs are typically graded as Mild, Moderate, Severe or Life Threatening.  Life Threatening AEs usually meet the criteria for a Serious Adverse Event (SAE) and must be reported to the Sponsor within 24 hours of study staff becoming aware of the AE.  An Adverse Event can also change grade over time as the AE improves or gets worse.  Each change of grade should be reported as a separate AE unless otherwise specified by the Sponsor.  For example, Nausea Grade 2 and Nausea Grade 1 would be reported as two separate AEs.

Cancer trials most commonly use the National Cancer Institute’s CTCAE which can be downloaded from their website.  Version 4.03 is the most current version, with a new version currently being reviewed for publication in September.


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