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The PRO-CTCAE measurement system is a patient-reported outcome (PRO) developed to capture symptomatic adverse events of patients in cancer clinical trials. The PRO-CTCAE V1.0 was designed to be used in conjunction with the Common Terminology Criteria for Adverse Events (CTCAE). It consists of an item library rather than a static/fixed item type of instrument. This item library concept is different than other CDISC public domain and copyrighted specific QRS instruments. Users are directed to use the form builder as described on the PRO-CTCAE website
to build CRFs with instructions provided by NCI to select the items to implement it in a clinical study. The PRO-CTCAE V1.0 includes multiple choice questions on the frequency, severity, interference, presence/absence and/or amount of specific adverse events.Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-463
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