For Industry

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

  • Study Data Technical Conformance Guide v. 4.1 (PDF - 581 KB) (March 2018) - This guide provides technical specifications, study data standardization plan, and general considerations on how to submit standardized electronic study data.
  • Therapeutic Area Information & Specifications
    The following section provides published specifications for additional information on study data submissions to CDER and CBER.

    • Human Immunodeficiency Virus
      HIV Technical Specifications Guidance v. 1.0 (PDF – 296 KB) (March 2018) - This document provides detailed information and specifications for the content of data sets that should be submitted as part of the sponsor’s/applicant’s application for drugs intended to treat human immunodeficiency virus (HIV). These specifications also provide an opportunity for dialogue between the sponsor/applicant and reviewers to discuss issues with trial design or study conduct that may affect the content of these analysis data sets. These specifications were built to support the recommendations provided in the guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment” and reflect the data standards and processes described in the FDA Study Data Technical Conformance Guide.
    • Vaccines
      Vaccines Technical Specification Guidance v1.0 - This document provides detailed information and specifications for the content of datasets submitted to FDA’s CBER Office of Vaccines Research and Review (OVRR). These specifications reflect current CBER OVRR thinking, are built to be consistent with the FDA Study Data Technical Conformance Guide, and are generally consistent with the Therapeutic Area User Guide (TAUG) for Vaccines.

 

4.  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

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.

5.  Position Statements

Additional Information

Learn more about FDA’s data standards initiatives.

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Page Last Updated: 05/11/2018
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