If you have study data questions for CDER, please contact the CDER eDATA Team at firstname.lastname@example.org.
For electronic submissions, contact the CDER Electronic Submission (ESUB) Support Team at email@example.com.
If you have study data questions for CBER, please contact CBERfirstname.lastname@example.org.
For electronic submissions, contact CBER ESUB at email@example.com.
Data standards enable FDA to modernize and streamline the review process. They also enable more consistent use of analysis tools to better view drug data and highlight areas of concern.
Study data standards describe a standard way to exchange clinical and nonclinical research data between computer systems. These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables, and standard ways of doing calculations with common variables.
FDA is instituting new requirements for data standards that will apply to most study data submitted to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
Beginning after the dates specified below, FDA may refuse to file for New Drug Applications (NDAs) and Biologics License Applications (BLAs) or refuse to receive for Abbreviated NDAs (ANDAs) any electronic submission whose study data do not conform to the required standards specified in the FDA Data Standards Catalog. See the Technical Rejection Criteria for Study Data (PDF) for more information. FDA conducted an analysis of study data conformance on submissions received during a specified time period and developed a presentation on the overall conformance results. To assist sponsors when submitting study data FDA has created the Technical Rejection Criteria Self-Check Worksheet (PDF), Worksheet Instructions (PDF), and Videos (PDF - 74KB) to demonstrate it's use.
CDER and CBER strongly encourage Investigational New Drug (IND) sponsors and NDA applicants to consider the implementation and use of study data standards as early as possible in the product development life cycle so that data standards are accounted for in the design, conduct, and analysis of studies.
- Sponsors whose studies start after Dec. 17, 2016, must submit data in the data formats supported by FDA and listed in the FDA Data Standards Catalog. This applies to NDAs, BLAs, ANDAs, and subsequent submissions to these types of applications.
- For INDs, the requirement applies for studies that start after Dec. 17, 2017.
For the definition of “study start date,” see the Guidance for Industry, Providing Regulatory Submissions in Electronic Format—Standardized Study Data (PDF - 131 KB)
Please see the guidance Providing Regulatory Submissions in Electronic Format -- Standardized Study Data and the Study Data Technical Conformance Guide for clarification regarding when electronic standardized study data are required as part of a submission to address a public health emergency declared by the Secretary of HHS.
Available resources for creating a Simplified ts.xpt as identified in the Technical Rejection Criteria for Study Data:
- Simplified ts.xpt Creation Guide (PDF - 852KB)
- Video demonstration: Creating a simplified ts.xpt using R
Clinical study data are information about a person in a clinical trial. Study data include demographic information, details of medical treatment, descriptions of the participant’s progress, and other relevant information. In early studies, this same information is captured for animals and is called nonclinical study data.
Commercial Investigational New Drug (IND) applications (for products that are intended to be distributed commercially)
New Drug Applications (NDAs)
Abbreviated New Drug Applications (ANDAs)
Biologics License Applications (BLAs)
All subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect
For exemptions, please see the Guidance for Industry, Providing Regulatory Submissions in Electronic Format — Standardized Study Data (PDF - 131 KB).
- Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document This document provides detailed information and specifications for the content of datasets submitted to FDA’s CBER Office of Vaccines Research and Review (OVRR). These specifications reflect current CBER OVRR thinking, are built to be consistent with the FDA Study Data Technical Conformance Guide, and are generally consistent with the Therapeutic Area User Guide (TAUG) for Vaccines.
- For clinical studies sent to CBER, we recommend that sponsors include a Study Data Standardization Plan (SDSP). Please see CBER SDSP appendix (SDSP Example Template Vaccine) at https://www.phuse.eu/css-deliverables for detail information.
- CBER currently does not require SEND (Standard for Exchange of Nonclinical Data) format for nonclinical study. However, SEND formatted datasets are acceptable.
Study data must be in a format supported by FDA at the time of the study’s start date. These formats are specified in the FDA Data Standards Catalog. The Data Standards Catalog lists all data standards supported by FDA, as well as all deadlines.
These study data standards were developed as part of a collaboration between FDA, the nonprofit Clinical Data Interchange Standards Consortium (CDISC), and other stakeholders.
Currently supported study data standards:
- CDISC Standard for Exchange of Nonclinical Data (SEND) for nonclinical data
- CDISC Study Data Tabulation Model (SDTM) for clinical data
- CDISC Analysis Data Model (ADaM) for analysis of clinical data
- CDISC Case Report Tabulation Data Definition Specification (Define-XML) for the metadata that accompany SEND, SDTM, and ADaM datasets
For detailed CDISC submission instructions, see the Study Data Implementation Guides.
FDA has the following procedures for updating standards:
- FDA will periodically publish its intent to begin supporting new standards and new versions of current standards.
- FDA will give at least one year’s notice before a new version of a standard is required.
- For entirely new standards, the notice will be at least two years.
- FDA is supporting efforts to develop clinical terminology standards for particular therapeutic areas within the SDTM. The SDTM will be updated periodically to include new and revised standards for specific therapeutic areas.
This process is further described in the Guidance for Industry — Providing Regulatory Submissions in Electronic Format — Standardized Study Data (PDF - 131KB). To learn more about how FDA identifies and develops study data standards, see CDER Study Data Standards Research and Development.
Visit the Study Data Standards Resources page for the most recent versions of FDA’s study data guidance and technical specifications, such as FDA guidance on study data standards, electronic source data, and other relevant technical specifications including the Study Data Technical Conformance Guide.
For additional guidance on specific topics, please visit Search for FDA Guidance Documents.
For additional information regarding eCTD, please visit the Electronic Common Technical Document (eCTD) page.
For information on electronic submissions to CBER, please visit Electronic Submission to CBER.
Contact Information and Questions
Important Related Information
- Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance For Industry; Technical Specifications Document
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the FD&C Act (PDF - 81KB)
- FDA Study Data Standards Resources
- Electronic Source Data in Clinical Investigations (PDF - 190KB)
- eStudy Data 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)