Streamline Your ePRO Implementation: Top 5 Best Practices
Integrating new technology into your clinical research can seem overwhelming, but with the right approach, electronic Patient Reported Outcomes (ePRO) can be a worthwhile investment for gathering high-quality data directly from patients. To help you navigate this journey, we’ve distilled five essential best practices for getting started with ePRO. These tips are designed to be straightforward and effective, ensuring you harness the full potential of ePRO technology.
1. Start Simple
The key to successful ePRO implementation is to begin with a manageable scope and to ideally outsource services to a single ePRO provider, treating this as an opportunity to learn. Adhere to the best practices suggested by your provider, even including the frequency of notifications and the layout of reports. This approach reduces complexity and sets a solid foundation to build upon for future studies.
2. Start Early
Preparation is key. Kick off your ePRO project with ample time on your side. A visual timeline can be incredibly helpful here to navigate you through the process, outlining each phase of implementation, from planning and design to user acceptance testing (UAT) and go-live. An early start ensures you have the buffer to accommodate time to learn the processes without derailing your study milestones.
3. Identify Your Team Members
Assemble a dedicated ePRO project team early on. This team should include a main point of contact (POC) for the ePRO provider, representatives from Clinical Operations, Medical Lead, Health Outcomes Lead, Data Management Lead, Lead Clinical Research Associate (CRA), and your Contract Research Organization (CRO) if applicable. These individuals will be crucial for design discussions, status meetings, and making pivotal decisions about the ePRO implementation.
4. Use the ePRO Solution Before UAT
Familiarize yourself with the ePRO solution well before the User Acceptance Testing (UAT) phase. Engaging with the tool in advance helps inform design decisions, ensuring the platform meets your needs. Early exposure can significantly reduce the likelihood of last-minute changes during UAT, a time when flexibility is limited, and deadlines are fast approaching.
5. Minimize Changes After Go-Live
Post-launch adjustments may seem simple but can introduce significant challenges. Whether it’s adding a new ePRO tool, altering the schedule, or modifying protocols, each change requires careful management to avoid disrupting ongoing studies. Any alterations need retraining for sites and CRAs, may impact ethical committee or institutional review board documentation for participants, and could affect data reporting and exports. Therefore, it’s crucial to minimize changes after your ePRO system goes live to maintain study integrity and data consistency.
By following these five best practices, you’ll position your ePRO implementation for success, enhancing the efficiency and effectiveness of patient-reported data collection in your clinical trials. Remember, a thoughtful approach to implementation can make a significant difference in the long-term value and utility of your ePRO system.