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.
Having standard, uniform study data enables FDA scientists to explore many new research questions by combining data from multiple studies. Data standards also help FDA receive, process, review, and archive submissions more efficiently and effectively.
This Study Data Resources page includes required items and helpful tools for submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH).
FDA accepts electronic submissions that provide study data using the standards, formats, and terminologies described in the FDA Data Standards Catalog.
To submit standardized study data using a standard that i was previously supported, see the guidelines for requesting a waiver to current supported clinical study data standard versions.
Centers other than CDER and CBER may have additional supported standards, so please check with the Center in question. Where indicated in the FDA Data Standards Catalog, study data standards are recognized and supported by CDRH but are currently voluntary. See Center-specific pages for further information.
2. FDA Guidances
These guidance documents describe the requirements for electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the Food, Drug, and Cosmetic (FD&C) Act.
- Providing Regulatory Submissions in Electronic Format - Standardized Study Data: Guidance for Industry (PDF - 136KB) (Dec. 2014) - This binding guidance describes the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act.
- Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the FD&C Act: Guidance for Industry (PDF - 81KB) (Dec. 2014) - This binding guidance discusses (1) the submission types that must be submitted electronically, (2) exemptions from and criteria for waivers of the electronic submission requirements, and (3) the timetable and process for implementing the requirements.
Additional Relevant Guidances
- Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry (PDF - 11KB)) (May 17, 2015) - This binding guidance describes the requirements for the electronic format for submissions under section 745A(a) of the FD&C Act.
- Electronic Source Data in Clinical Investigations: Guidance for Industry (PDF - 52KB) (Sept. 2013)- This non-binding guidance provides recommendations to sponsors, contract research organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations
- Study Data Technical Conformance Guide v. 3.3 (PDF - 1.17MB) (Mar. 2017) - This guide provides technical specifications, recommendations, and general considerations on how to submit standardized electronic study data.
4. Standardization Plan Recommendations
- CDER/CBER Study Data Standardization Plan Recommendations (PDF - 51.74KB) - Recommendations for preparing a study data standards plan for CDER or CBER.
5. Business Rules
Validation activities occur at different times during submission and review of study data, including submission receipt and at the beginning of the regulatory review. Validation of study data that occurs upon receipt of a submission follows the process for Technical Rejection Criteria for Study Data.
The rules below support regulatory review and analysis of study data:
The Business Rules help ensure that the study data are compliant, useful, and will support meaningful review and analysis. This applies to SDTM formatted clinical studies and SEND formatted non-clinical studies. For more information see Section 8 of the Technical Conformance Guide.
The Validator Rules are used by the FDA to ensure data are standards compliant and support meaningful review and analysis.
6. Position Statements
Learn more about FDA’s data standards initiatives.
- Electronic Common Technical Document (eCTD) - For information on submitting to FDA electronically.
- CDER Data Standards Program - Information about CDER’s program efforts to standardize data and help FDA meet its performance goals under the Prescription Drug User Fee Act V.
Research and Collaborations
The purpose of the study data standards is to enable the exchange of data between researchers and FDA. These tools aid in research and collaboration.
- Data Standards Research Areas and Collaborations - Ongoing FDA study data exchange standards research and development activities.
- DS-XML Pilot Final Report (PDF - 152KB) (Apr. 2015) - Test Report for DS-XML Pilot Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER).
- Study Design Standard - Health Level Seven (HL7) Study Design Structured Document Standard (SDSD) captures both structured and unstructured information on the design of an investigational study.
- Stability Data Standard - HL7 standard to facilitate the processing and review of stability data.
- Study Participation Standard - Information about experimental units, investigators, and other relevant entities that are involved in the conduct of an individual study.
- Subject Data Standard - Information on an individual study subject, including observations, substance administration, supplies, and procedures.
- Janus Clinical Trials Repository - Data warehouse for subject-level clinical trial data submitted to FDA as part of marketing applications. The repository provides FDA staff easy access to clinical trial data to support regulatory review and to support analyses across studies that address public health and research questions as they emerge.
- For additional information/support from CDER, please contact firstname.lastname@example.org or visit Study Data for Submission to CDER and CBER.
- For additional information/support from CBER, please contact email@example.com or visit Study Data for Submission to CBER.
- For additional information/support from CDRH, please contact firstname.lastname@example.org or visit Data Standards and Terminology Standards for Information Submitted to CDRH.