The Contractor shall develop the Patient-Reported Outcomes version of symptom elements that are contained within the Common Terminology Criteria for Adverse Events (PRO-CTCAE). This system will collect cancer patients' responses to questions about their health status, symptoms, functioning and health-related quality of life and integrate this information within the NCI adverse event reporting system. The Contractor shall produce a detailed document that identifies barriers, ideal conditions, and solutions to implement the PRO-CTCAE, develop the PRO-CTCAE assessment software system fully integrated with the CTCAE, conduct studies to evaluate the validity, reliability, feasibility and clinical utility of the new PRO-CTCAE, and create Training and Educational Materials to Support the PRO-CTCAE.
