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  1. FDA Data Standards Advisory Board

This page provides quick links to key guidances to support the submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Veterinary Medicine (CVM) and provides a common site where guidances and technical documents related to study data standards are displayed together. Every guidance listed below may not apply to all centers. Each link provides more complete information on the document.

CDER and CBER, in collaboration with CDISC and PhUSE, has conducted preliminary testing of CDISC’s Dataset JSON message exchange standard. Initial results indicate potential use as a replacement for XPT v5. As such, CBER and CDER will conduct further testing to evaluate Dataset JSON’s capability to support the submission of regulatory study data. Results will be communicated, and we will engage relevant parties for input as we progress through this evaluation.


FDA Business and Validator Rules

Validation activities occur at different times during submission and review of study data, including submission receipt and at the beginning of the regulatory review. 

The rules below support regulatory review and analysis of study data: 

  • FDA Business Rules
    The Business Rules v1.5 (May 2019) help ensure that the study data are compliant, useful, and will support meaningful review and analysis.  This applies to SDTM formatted clinical studies and SEND formatted non-clinical studies.  For more information see Section 8 of the Technical Conformance Guide.

  • FDA Validator Rules
    The Validator Rules v1.6 (December 2022) are used by the FDA to ensure data are standards compliant and support meaningful review and analysis.

Additional Resources

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