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        FDA Data Standards Advisory Board

Study Data Standards Resources

                        
                Study Data for Submission to CDER and CBER Home
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          FDA Data Standards Advisory Board
          Study Data Standards ResourcesFDA Data Standards Advisory Board Study Data Standards Resources
  	
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eCTD Resources
	Data Standards Catalog
	Study Data Technical Conformance Guide

This page provides quick links to key guidances to support the submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Veterinary Medicine (CVM) and provides a common site where guidances and technical documents related to study data standards are displayed together. Every guidance listed below may not apply to all centers. Each link provides more complete information on the document.

CDER and CBER, in collaboration with CDISC and PhUSE, has conducted preliminary testing of CDISC’s Dataset JSON message exchange standard. Initial results indicate potential use as a replacement for XPT v5. As such, CBER and CDER will conduct further testing to evaluate Dataset JSON’s capability to support the submission of regulatory study data. Results will be communicated, and we will  engage stakeholders for input as we progress through this evaluation.


Guidances

(745A(a)) - Providing Submissions in Electronic Format Under Section 745A(a) of the FD&C Act
	(eStudy) - Providing Submissions in Electronic Format - Standardized Study Data
	(eCTD) - Providing Submissions in Electronic Format using the eCTD Specifications
	(RWD) - Data Standards for Drug and Biological Product Submissions Containing Real-World Data
	(ICSR) - Providing Regulatory Submissions in Electronic Format - IND Safety Reports
	(BIMO) - Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections for CDER Submissions
	(sdTCG) - Study Data Technical Conformance Guide
	(BIMO TCG) - Bioresearch Monitoring Technical Conformance Guide
	(ICSR TCG) - Electronic Submissions of IND Safety Reports Technical Conformance Guide
	FDA Data Standards Catalog
	Tech Spec - Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
	Tech Spec - Bioanalytical Methods Templates
	Tech Spec - Clinical Endpoint BE Studies
	Tech Spec - HIV
	Tech Spec - QT Studies
	Tech Spec - Next Gen Sequencing
	Tech Spec - Rodent Carcinogenicity Studies
	Tech Spec - Vaccines
	Tech Spec - Noncirrhotic Nonalcoholic Steatohepatitits (NASH)
	Tech Spec - M11
	Tech Spec - Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
	Data Standards and Terminology Standards for Information Submitted to CDRH
	Electronic Source Data in Clinical Investigations
	Tech Spec - Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
	Tech Spec - Submitting Patient-Reported Outcome Data in Cancer Clinical TrialsFDA Business and Validator 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.

The rules below support regulatory review and analysis of study data:

**FDA Business Rules**
	The Business Rules v1.5 (May 2019) 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.
	**FDA Validator Rules**
	The Validator Rules v1.6 (December 2022) are used by the FDA to ensure data are standards compliant and support meaningful review and analysis.Additional Resources

Electronic Common Technical Document (eCTD)
	CDER Data Standards Program
	Recommendations for the Submission of LOINC Codes in Regulatory Applications to the U.S. Food and Drug Administration
	Guidelines for Requesting Waiver to Current Supported Clinical Study Data Standard Versions
	Definitions from the GLP regulations for nonclinical laboratory studies
	Data Standards and Terminology Standards for Information Submitted to CDRH**Stay Connected**

For additional information/support from CDER, please contact cder-edata@fda.hhs.gov
	For additional information/support from CBER, please contact cber-edata@fda.hhs.gov
	For additional information/support from CDRH, please contact cdrh.datastandards@fda.hhs.gov

                                                                                  Content current as of:
      12/08/2023
                  
                   
Regulated Product(s)
		 DrugsStudy Data Standards Resources                
                          

                        Study Data for Submission to CDER and CBER
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