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Study Data Standards Resources

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Study data standards describe a standard way to exchange clinical and nonclinical research data between computer systems. These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables, and standard ways of doing calculations with common variables.
Having standard, uniform study data enables FDA scientists to explore many new research questions by combining data from multiple studies. Data standards also help FDA receive, process, review, and archive submissions more efficiently and effectively.

This Study Data Resources page includes required items and helpful tools for submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH).

1.  FDA Data Standards Catalog

FDA accepts electronic submissions that provide study data using the standards, formats, and terminologies described in the FDA Data Standards Catalog.

To submit standardized study data using a standard that i was previously supported, see the guidelines for requesting a waiver to current supported clinical study data standard versions.

Centers other than CDER and CBER may have additional supported standards, so please check with the Center in question.  Where indicated in the FDA Data Standards Catalog, study data standards are recognized and supported by CDRH but are currently voluntary. See Center-specific pages for further information.

2.  FDA Guidances

These guidance documents 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.

Additional Relevant Guidances

3.  Technical Guides

4.  Standardization Plan Recommendations

5.  Business 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.  Validation of study data that occurs upon receipt of a submission follows the process for Technical Rejection Criteria for Study Data.

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

  • Business Rules
    The Business Rules  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.

  • Validator Rules
    The Validator Rules  are used by the FDA to ensure data are standards compliant and support meaningful review and analysis.

6.  Position Statements

Additional Information

Learn more about FDA’s data standards initiatives.

Research and Collaborations

The purpose of the study data standards is to enable the exchange of data between researchers and FDA. These tools aid in research and collaboration.

  • Data Standards Research Areas and Collaborations - Ongoing FDA study data exchange standards research and development activities.
    • DS-XML Pilot Final Report (PDF - 152KB) (Apr. 2015) - Test Report for DS-XML Pilot Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER).
    • Study Design Standard - Health Level Seven (HL7) Study Design Structured Document Standard (SDSD) captures both structured and unstructured information on the design of an investigational study.
    • Stability Data Standard - HL7 standard to facilitate the processing and review of stability data.
    • Study Participation Standard - Information about experimental units, investigators, and other relevant entities that are involved in the conduct of an individual study.
    • Subject Data Standard - Information on an individual study subject, including observations, substance administration, supplies, and procedures.
  • Janus Clinical Trials Repository - Data warehouse for subject-level clinical trial data submitted to FDA as part of marketing applications. The repository provides FDA staff easy access to clinical trial data to support regulatory review and to support analyses across studies that address public health and research questions as they emerge.

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Page Last Updated: 09/01/2017
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