FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts on how sponsors can comply with the Federal Food, Drug and Cosmetic Act (FDCA) when submitting “certain” applications that contain study data derived from real-world data (RWD) sources. The FDA acknowledges that its current study data standards do not necessarily reflect a process derived from RWD sources. However, sponsors will need to convert RWD into established study data standards when submitting this information as part of a regulatory application (a process called “mapping”).

For context, study data standards are documented guidelines to help with the exchange of clinical and nonclinical study data between computer systems. They are used to provide a consistent framework for organizing study data (such as templates for datasets, standard names for variables, how to do calculations with common variables, and so on).