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

• Specifications for submitting animal and human study datasets in electronic format: Study Data Specifications (PDF).

1.2 Study Data File Format Standards

• SAS Transport Version 5
  • Organization – CBER, CDER, CDRH 
  • Use for Study datasets
• XML Version 1.0
  • Organization – CBER, CDER
  • Use for SDTM and ADaM define.xml file
• PDF Versions 1.4/1.5/1.6
  • Organization – CBER, CDER, CDRH
  • Use for SDTM and ADaM define.pdf
• American Standard Code for Information Interchange (ASCII)
  • Organization – CBER, CDER, CDRH
  • Use for SAS program files (use the .txt filename extension)

1.3 Study Data Exchange and Analysis Standards

• CDISC SDTM Version 1.2, Implementation Guide 3.1.2
  • Organization – CBER, CDER, CDRH 
  • Use for Human study tabulation data
• CDISC SDTM Version 1.1, Implementation Guide 3.1.1
  • Organization – CBER, CDER, CDRH 
  • Use for Human study tabulation data
  • Timing – Only for studies initiated prior to 2011-06-13
• CDISC SDTM Version 1.2, SEND Implementation Guide 3.0
  • Organization – CDER
  • Use for General toxicology and carcinogenicity study tabulation data
• CDISC ADaM Version 2.1, Implementation Guide 1.0
  • Organization – CBER, CDER, CDRH 
  • Use for Human study data analysis datasets

1.4 Study Data Terminology Standards

• General: CDISC Terminology Version 2011-06-10 or later
  • Organization – CBER, CDER
  • Use CDISC submission values
• General: CDISC Terminology, All Previous Versions
  • Organization – CBER, CDER
  • Use CDISC submission values
  • Timing – Only for studies initiated prior to 2011-06-13
• Adverse Events: Medical Dictionary for Regulatory Activities (MedDRA) Version 8 or later
  • Organization – CBER, CDER
  • Use for CDISC Adverse Events (AE) Domain
• Adverse Events: CDRH Device Problem Codes
  • Organization: CDRH
  • Use CDISC Adverse Events (AE) Domain to report device problems
• Medication: FDA Unique Ingredient Identifier (UNII)
  • Organization – CBER, CDER
  • Use the SRS preferred substance name in CDISC TS domain for TSVAL where TSPARMCD is any of the following: TRT, CURTRT, COMPTRT
• Pharmacological Class: National Drug File – Reference Terminology (NDF-RT)
  • Organization – CDER
  • Use in CDISC TS domain for TSVAL where TSPARMCD=PCLAS and TSPARM = Pharmacologic Class. Use FDA Established Pharmacologic Class for FDA approved moieties (see reference)
  • References:
  • Pharmacologic Class Guidance
    
  • http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162549.htm
• Indication: Systemized Nomenclature of Medicine-Clinical Terms (SNOMED CT)
  • Organization – CBER, CDER
  • Use for CDISC TS domain for TSVAL where TSPARMCD=INDIC

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 .

• SDTM 3.1.2 (v.1.2) Organization: CBER, CDER
• SDTM 3.1.1 (v1.2)   Organization: CBER, CDER
• Define.xml 1.0 (v1.2)   Organization: CBER, CDER
• ADaM 1.0 (v.1.0)
• SEND  

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

• CBER Study Data Standards
• For additional information/support, please contact cber.cdisc@fda.hhs.gov
• CDER Study Data Standards
• For additional information/support, please contact  cder-edata@fda.hhs.gov 
• CDRH Study Data Standards
• For additional information/support, please contact cdrh.cdisc@fda.hhs.gov

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.cfm.

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