R&D-OTHER R & D-A RES/EXPL DEV

承包商应制定所包含的症状要素的患者报告结果版本 在不良事件通用术语标准(PRO-CTCAE)范围内。这个系统将收集癌症患者的 回答有关他们的健康状况、症状、功能和与健康相关的生活质量的问题，并融入 NCI不良事件报告系统中的这些信息。 承包商应编制一份详细的文件，确定障碍、理想条件和实施解决方案 PROCTCAE，开发PRO-CTCAE评估软件系统，与CTCAE完全集成，进行 评估新PROCTCAE的有效性、可靠性、可行性和临床实用性的研究，并创建培训 和教育材料，支持支持CTCAE。

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.