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RWD Reliability
Ensuring RWD reliability is essential for generating credible RWE.
The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework
Paper
A Structured Process to Identify Fit-for-Purpose Study Design and Data to Generate Valid and Transparent Real-World Evidence for Regulatory Uses
Paper
SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility
Paper
Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data
Paper
