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RWD Reliability
Ensuring RWD reliability is essential for generating credible RWE.
Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
Guidance
RWD in SDTM is Unreliable, Until It Isn’t
Blog Post
Know Thy Data: Trusting RWD in Common Data Models for Regulatory Submissions
Blog Post
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
Guidance
Determining Real-World Data’s Fitness for Use and the Role of Reliability
Paper
Characterizing RWD Quality and Relevancy for Regulatory Purposes
Paper
A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real-World Evidence for Regulatory Decisions
Paper
The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework
Paper
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