Study Data Standards Resources
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)
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 For CDER and CBER: Draft Guidance for Industry - Providing Regulatory Submissions in Electronic Format — Standardized Study Data.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, when final, will describe how FDA plans to implement the requirements for the electronic submission of standardized study data.
3. Draft Study Data Technical Conformance Guide. Click here to access the Guide. The Guide, when final, will provide technical specifications, recommendations, and general considerations on how to submit standardized electronic study data.
The following resources remain available until the publication of the final Study Data Technical Conformance Guide:
Study Data Specifications (Click here)
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. Externally (to-FDA) Defined Validation Rules
When not defined by FDA, the following available resources are used.
The OpenCDISC Validator and the study validation rules are available for download as standard configuration files.
- SDTM 3.1.3 (v1.1) Organization: CBER, CDER
- SDTM 3.1.2 (v.1.5) Organization: CBER, CDER
- SDTM 3.1.1 (v1.5) Organization: CBER, CDER
- Define.xml 1.0 (v1.4) Organization: CBER, CDER
- ADaM 1.0 (v.1.0)
Additional Center-specific information
- CBER Study Data Standards For additional information/support, please contact : email@example.com
- CDER Study Data Standards For additional information/support, please contact: firstname.lastname@example.org
- CDRH Study Data Standards For additional information/support, please contact: CDRH.DataStandards@fda.hhs.gov Where indicated in the Data Standards Catalog, study data standards are recognized and supported by the Center, but are currently voluntary. See Center-specific page CDRH Study Data Standards.
5. Other Relevant Guidance and Information
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the FD&C Act.
- Electronic Common Technical Document (eCTD)
- Guidance for Industry: Electronic Source Data in Clinical Investigations