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U.S. Department of Health and Human Services

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Study Data Standards Resources


1. Study Data Standards in Current Use

Please refer to the following standards and resources for study data submissions to FDA.

For Center-specific resources, please click here.

1.1 Study Data Specifications

1.2 Study Data File Format Standards

1.3 Study Data Exchange and Analysis Standards

1.4 Study Data Terminology Standards

1.5 Download a catalog of FDA-supported Study Data Standards for offline viewing (XLS)

  • Please read the instructions on using the Data Standards Catalog

1.6 Study Data Validation Rules

The study validation rules are available for download as standard configuration files for OpenCDISC Validator disclaimer icon .

1.7 For Center-specific resources, please refer to the following:

2. Study Data Exchange Standards Currently Under Development

The following resources support ongoing FDA study data exchange standards research and development activities within HL7. These standards are currently not utilized for regulatory submissions of study data.

The purpose of the study data standards is to exchange data between researchers and FDA. The human and animal study data will be stored in the Janus data warehouse, a repository, which allows users to generate views for analysis with different end-user tools.

One of the important goals of FDA in the development and adoption of standards based on Health Level Seven (HL7) Reference Information Model (RIM) is to support meaningful information representation and exchange between systems in use by clinical researchers, FDA (Janus data warehouse) and health care providers (electronic health record systems).

Since 2007, FDA has collaborated with CDISC and other stakeholders within the HL7 Regulated Clinical Research Information Management (RCRIM) Workgroup on the development of study data exchange standards based on HL7 version 3. General RCRIM Workgroup information is available at http://www.hl7.org/Special/committees/rcrim/index.cfmdisclaimer icon.

Highlights on study data exchange standards development activities are available below.

The Study Design, Study Participation and Subject Data exchange standards passed the HL7 September 2009 ballot cycle as Draft Standard for Trial Use (DSTU).  The Individual Case Safety Report release 2 is being balloted as a joint ISO/HL7/CEN ballot

Study Design Standard

Study Participation Standard

Subject Data Standard

Individual Case Safety Report Standard