CANCER TRIALS SUPPORT UNIT IDIQ: TASK ORDER 6A: ELECTRONIC PATIENT-REPORTED OUTCOMES (PROS)

癌症试验支持单位 IDIQ：任务令 6A：电子患者报告结果（优点）

• 批准号: 10703864
• 负责人: JAMES WISE
• 金额: $ 82.15万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10703864
• 关键词: Cancer Trials Support Unit; Clinical; Clinical Trials; Collection; Computer software; Contractor; Data; Databases; Decision Analysis; Development; Health; Human; Human Resources; Libraries; Life Cycle Stages; Methodology; Modeling; National Cancer Institute; Patient Outcomes Assessments; Patients; Performance; Phase; Process; Questionnaires; Recommendation; Resources; Services; System; Training; Update; health data; migration; programs

The primary objective of the project is to provide operational and development support to the NCI clinical trials program in its effort to identify, deploy, support, and maintain a system for the collection and migration of electronic Patient-Reported Outcomes (ePROs) and other patient-generated health data (PGHD) into the National Cancer Institute (NCI) clinical trial process and systems. The project will be approached in two phases: Phase 1: Requirements and Recommendations, Phase 2: System Configuration and Implementation. The primary objective of Phase 1 will be to identify the requirements for ePRO management, develop a pilot implementation plan, and recommend a software solution that satisfies all stakeholder requirements. The primary objective of Phase 2 will be to build new or modify/configure a commercial off-the-shelf (COTS) product and then maintain, update, and enhance it by following Capability and Maturity Model Integration (CMMI) practices and the Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) methodology, working with stakeholders to gather requirements, using a 'Make vs. Buy' decision analysis practices, implementation and configuration, and creating training materials, providing user support as well as a library of licensed PRO questionnaires.

该项目的主要目标是为 NCI 临床试验项目提供运营和开发支持 它致力于识别、部署、支持和维护一个系统，用于收集电子患者报告结果 (ePRO) 和其他患者生成的健康数据 (PGHD) 并将其迁移到国家癌症研究所 (NCI) 临床试验流程和系统中。该项目将分两个阶段进行：第一阶段：要求和建议，第二阶段：系统配置和实施。第一阶段的主要目标是确定 ePRO 管理的要求，制定试点实施计划，并推荐满足所有利益相关者要求的软件解决方案。第二阶段的主要目标是构建新的或修改/配置商业现成 (COTS) 产品，然后通过遵循能力和成熟度模型集成 (CMMI) 实践和健康与人类服务 (HHS) 企业绩效生命周期 (EPLC) 方法来维护、更新和增强它，与利益相关者合作收集需求，使用“自制与购买”决策分析实践、实施和配置，并创建培训材料，提供 用户支持以及许可的 PRO 调查问卷库。