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U.S. Department of Health and Human Services

For Industry

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Study Data Standards Resources

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 CBER/CDER Study Data Standards for Regulatory Submissions Position Statement

 CDER/CBER Position on Use of SI Units for Lab Tests

1. The Agency can process, review, and archive electronic submissions that provide study data using the standards, formats, and terminologies specified in the Data Standards Catalog (Click here)

2.  For CDER and CBER: Draft Guidance for Industry - Providing Regulatory Submissions in Electronic Format — Standardized Study Data.  Click here to access the full guidance document.  The guidance, when final, will describe how FDA plans to implement the requirements for the electronic submission of standardized study data. 

3.   Draft Study Data Technical Conformance Guide.  Click here to access the Guide.  The Guide, when final,  will provide technical specifications, recommendations, and general considerations on how to submit standardized electronic study data.

The following resources remain available until the publication of the final Study Data Technical Conformance Guide: 
Study Data Specifications (Click here)

4. Study Data Validation Rules

4a.    FDA Specific SEND Validation Rules
The following document outlines FDA’s validation rules for SEND formatted non-clinical studies.  Nonclinical Validator Specifications (XLS)

4b.   Externally (to-FDA) Defined Validation Rules
When not defined by FDA, the following available resources are used.

The OpenCDISC Validator disclaimer icon  and the study validation rules are available for download as standard configuration files.
- SDTM 3.1.3 (v1.1) disclaimer icon  Organization: CBER, CDER
- SDTM 3.1.2 (v.1.5) disclaimer icon  Organization: CBER, CDER
- SDTM 3.1.1 (v1.5) disclaimer icon  Organization: CBER, CDER
- Define.xml 1.0 (v1.4) disclaimer icon  Organization: CBER, CDER
- ADaM 1.0 (v.1.0) disclaimer icon  

Additional Center-specific information

5.  Other Relevant Guidance and Information

 

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