For Industry

Study Data Standards Resources

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Important Notices:

  • Guidance for Industry - Providing Regulatory Submissions in Electronic Format — Standardized Study Data (Dec 17, 2014)
  • Data Standards Catalog v4.0 (Dec 17, 2014)
  • Study Data Technical Conformance Guide v2.0 (Dec 17, 2014)
  • FDA Specific SEND Validation Rules v2.0 (Dec 11, 2014)
  • FDA Specific SDTM Validation Rules v1.0 (Nov 18, 2014)

 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) For Centers other than CBER and CDER there may be additional supported standards, please check with the specific Center.

To submit standardized study data using a standards that is unsupported or retired, see the guidelines for requesting a waiver to current supported clinical study data standard versions.

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  For CDER and CBER: Draft Guidance for Industry - Providing Regulatory Submissions in Electronic Format — Standardized Study Data.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 describes how FDA plans to implement the requirements for the electronic submission of standardized study data. 

3.   Study Data Technical Conformance Guide v2.0.  Click here to access the Guide.  This Guide provides technical specifications, recommendations, and general considerations on how to submit standardized electronic study data.

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.    FDA Specific SDTM Validation Rules
The following document outlines FDA’s validation rules for SDTM formatted clinical studies. SDTM Validator Specification (XLS)

 

Additional Center-specific information

5.  Other Relevant Guidance and Information

 

Page Last Updated: 12/17/2014
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