- Study Data Technical Conformance Guide v3.2 (October 31, 2016)
- Technical Rejection Criteria for Study Data (October 3, 2016)
- Data Standards Catalog v4.5.1 (September 29, 2016)
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) For Centers other than CBER and CDER there may be additional supported standards, please check with the specific Center.
To submit standardized study data using a standards that is unsupported or retired, see the guidelines for requesting a waiver to current supported clinical study data standard versions.
2. For CDER and CBER: Guidance for Industry - Providing Regulatory Submissions in Electronic Format — Standardized Study Data. Click here to access the full guidance document. The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data.
3. Study Data Technical Conformance Guide v3.2 Click here to access the Guide. This Guide provides technical specifications, recommendations, and general considerations on how to submit standardized electronic study data.
3a. Recommendations for Preparing a Study Data Standardization Plan (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. FDA Specific SDTM Validation Rules
The following document outlines FDA’s validation rules for SDTM formatted clinical studies. SDTM Validator Specification (XLS)
Additional Center-specific information
- CBER Study Data Standards For additional information/support, please contact : firstname.lastname@example.org
- CDER Study Data Standards For additional information/support, please contact: email@example.com
- 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 for further information.
5. Other Relevant Guidance and Information
- 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