Understanding FDA Study Data Standards

The U.S. Food and Drug Administration (FDA) has study data standards to enhance the efficiency of the submission process.  The data standards provide a consistent general framework for organizing study data.  It is essential to stay up-to-date on these standards to create a smoother submission process for all parties involved.

What are Study Data Standards?

Study data standards describe a standard way to exchange clinical and nonclinical study data. The FDA accepts electronic submissions using the standards, formats, and terminologies described in the FDA Data Standards Catalog.  The FDA Data Standards Council consistently evaluates and maintains the adoption of health and regulatory data standards to ensure that the agency can follow common data standards.

When capturing source data in electronic form, it is essential to ensure reliability, quality, integrity, and traceability from the source to the regulatory submission. Study data includes templates for datasets, standard names for variables, identify appropriate controlled terminology, and standard ways of doing calculations with common variables.

The FDA frequently evaluates data standards to help receive, process, review, and archive submissions more efficiently and effectively. The FDA has developed guidance documents that describe the requirements for electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the Food, Drug, and Cosmetic (FD&C) Act.

To access FDA’s study data resources, go to: www.fda.gov/fda-resources-data-standards.  Stat One is committed to providing expert clinical support and following these standards effectively.  To speak with the Stat One team, click here, or email info@statonellc.com.

To speak with our team, go to: https://www.statonellc.com/contact/.

You can view the FDA guidance document here: https://www.fda.gov/media/136238/download.