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- W2395610946 abstract "This conceptual paper defines the electronic Patient Reported Outcome (ePRO) Product Life Cycle, identifying key items in each Phase important to the study’s success, and focuses on the Management (Maintenance) Phase. After the ePRO mode and system provider have been selected, the ePRO product life cycle begins. This Product Life Cycle includes three distinct Phases: Set-Up, Management, and Close-Out. During the Set-Up Phase, the provider and key study team stakeholders work together to define/customize, document, and finalize the study’s specific system requirements in a Requirements Specification document. The ePRO system is then developed by programmers and validated by test analysts. The key study stakeholders perform User Acceptance Testing (UAT) of the final system to ensure the ePRO system functions as expected and detailed in the specifications. Once the stakeholders approve UAT, the ePRO system is released for trial use. When the system goes Live, the project transitions to the Management Phase. Although the Set-Up Phase involves substantial effort, the work is not over as proactive involvement in the Management Phase is critical for the study’s success and for optimal patient experience. This is when the ePRO system will be used by patients, and supported by sites, study teams, and the provider. An effective Study Management Plan should be in place to describe fundamental requirements during the Live study. Essential items in the Management Phase include user support, project management, tracking/monitoring, training/re-training, and preparedness for any mid-trial changes. This conceptual paper will provide an assessment of key requirements for proactive project management and will provide examples including prepared Tech Support Groups and compliance monitoring/follow-up by the study team. Finally, the Close-Out Phase begins after the last patient has completed their final ePRO event. The database is locked and the ePRO system is retired/decommissioned." @default.
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- W2395610946 date "2016-05-01" @default.
- W2395610946 modified "2023-09-30" @default.
- W2395610946 title "Epro Product Life Cycle: Guidance For A Successful Management Phase" @default.
- W2395610946 doi "https://doi.org/10.1016/j.jval.2016.03.1706" @default.
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