As clinical trials become more global and patient-centered, capturing patient experiences accurately across diverse populations is crucial. Electronic Patient-Reported Outcomes (ePRO) offer significant advantages over traditional paper-based methods, such as real-time data capture, improved compliance, and cost efficiency. However, to fully unlock the benefits of ePRO in multinational trials, rigorous linguistic and form validation is essential to ensure data quality, regulatory compliance, and patient engagement.
This white paper explores the key steps involved in linguistic and form validation, their impact on data integrity, patient-centricity, and cross-cultural comparability, and provides best practices to optimize ePRO systems for global use.
Key Points:
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The Rise of ePRO in Clinical Trials
- ePRO systems improve data quality, patient engagement, and cost efficiency by enabling direct, real-time reporting from patients.
- Regulatory support, patient preference, and advancements in technology drive the adoption of ePRO.
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Linguistic and Form Validation
- Linguistic Validation ensures conceptual equivalence across languages and cultural contexts through steps like translation, expert review, and cognitive testing.
- Form Validation guarantees that the electronic version of a PRO instrument functions correctly across different devices and retains measurement properties equivalent to paper versions.
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Importance of Validation for ePRO
- Proper validation maintains data integrity, prevents errors, and supports regulatory compliance.
- Ensures that ePRO instruments remain patient-centric, improving patient engagement and cross-cultural data comparability.
- Provides long-term cost savings by reducing data cleaning and minimizing trial delays.
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Best Practices for Validation
- Involve professional linguists and instrument developers.
- Conduct cognitive debriefing and usability testing.
- Ensure technical compatibility across devices.
- Maintain thorough documentation and cultural adaptation.
Download the white paper now to learn how to enhance the success of your clinical trials and maximize the value of ePRO data collection across different languages, cultures, and electronic platforms.
