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FDA Review and Inspection of Real-World Data in Regulatory Submissions
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Core Concepts in Pharmacoepidemiology: Validation of Health Outcomes of Interest Within Real-World Healthcare Databases
Guidance of development, validation, and evaluation of algorithms for populating health status in observational studies of routinely collected data (DEVELOP-RCD)
How to validate a diagnosis recorded in electronic health records
Validation and impact of algorithms for identifying variables in observational studies of routinely collected data
Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms’ Fit for Purpose for Safety Outcomes
Accuracy of heart failure ascertainment using routinely collected healthcare data: a systematic review and meta-analysis
Intra-database validation of case-identifying algorithms using reconstituted electronic health records from healthcare claims data
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