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

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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.