CDER strongly encourages IND sponsors and NDA applicants to consider the implementation and use of data standards for the submission of applications. Such implementation should occur as early as possible in the product development lifecycle, so that data standards are accounted for in the design, conduct, and analysis of studies. These resources are intended to assist submitters in the preparation and submission of standardized study data to CDER.
CDER’s Study Data requirements are covered in the Data Standards Catalog and the Study Data Technical Conformance Guide that are available on the Study Data Standards Resources webpage:
Study Data Technical Conformance Guide
This Guide provides technical specifications, recommendations, and general considerations on how to submit standardized electronic study data.
Data Standards Catalog
The Agency can process, review, and archive electronic submissions that provide study data using the standards, formats, and terminologies specified in the Catalog.
Questions regarding datasets should be forwarded to the CDER eData team at email@example.com.
CDISC Study Data Tabulation Model (SDTM)
- SDTM Implementation Guide for Human Clinical Trials (SDTM IG) - Developed by the Clinical Data Interchange Standards Consortium (CDISC), the SDTM IG is an implementation of the SDTM for clinical study data. The conceptual model and SDTM IG can be obtained from the CDISC web site at: http://www.cdisc.org/sdtm.
- Standard for Exchange of Nonclinical Data Implementation Guide (SEND IG) - Developed by CDISC, the SEND IG is an implementation of the SDTM for data collected from animal toxicology studies. The IG can be obtained from the CDISC website at: http://www.cdisc.org/send.
- CDISC Analysis Data Model (ADaM) - Developed by CDISC, ADaM is an analysis dataset standard accepted by CDER. The Model and Implementation Guide can be obtained from the CDISC web site at: http://www.cdisc.org/adam.
For a fact sheet on study data standards requirements, see below:
Important Related Information
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the FD (PDF - 81KB)
- FDA Study Data Standards Resources
Electronic Source Data in Clinical Investigations(PDF - 190KB)
- eStudy Data Draft Guidance (PDF - 132KB)
- Electronic Submission to CBER
CDER Study Data Standards Research and Development
- Guidance for Industry: Electronic Source Data in Clinical Investigations (PDF - 190KB)