RWE and the FDA (Part 1)
The Effective Statistician - in association with PSI
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Using Electronic Health Records and Medical Claims to SupportRegulatory Decision Making
Four guidance documents were released in four consecutive months last year, between september and december. They organized that into three major themes: data sources, study design elements and data quality. The first big theme on data sources discusses the general nature of claims and electronic health records. And yet, they talk about what are the important elements you must consider in deciding if a given data source will meet the needs of your study.
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