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  1. FDA Data Standards Advisory Board

Study Data Standards Resources

Study data standards describe a standard way to exchange clinical and nonclinical study data. These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables, identify appropriate controlled terminology and standard ways of doing calculations with common variables. Data standards also help FDA receive, process, review, and archive submissions more efficiently and effectively.

This Study Data Resources page includes required items and helpful tools for submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH).

Learn More About FDA's Data Standards Initiatives

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