RWE and the FDA (Part 2)
The Effective Statistician - in association with PSI
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Clinical Trial Concepts - What Are They?
FDA describe outcome, ascertainment and validation is that first what you need to do is to generate a conceptual definition for your outcome. This needs to be a definition that can be operationalized in real world data sources. And yeah, this can be using coding systems that are part of the structured data or unstructured data. So from physicians in counter notes or radiology and pathology reports to really curate the end point you're looking for.
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