CTCAE: Common Terminology Criteria for Adverse Events

The National Cancer Institute issued the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 on November 27, 2017. So what is CTCAE and what is it used for? The terminology NCI CTCAE is a descriptive terminology that can be used for the declaration of adverse events (AEs). A grade scale (or severity) is providedContinue reading “CTCAE: Common Terminology Criteria for Adverse Events”

Data Management Plan – Coding and Reconciliation

All Adverse Events and Previous/Concomitant Medication should be coded and/or approved prior and during the trial. Before adverse event terms can be reported or analyzed, they must be grouped based on their similarities. For example, headache, mild headache and acute head should all be counted as the same kind of event. This is done byContinue reading “Data Management Plan – Coding and Reconciliation”