Study Data Standards Resources
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Study data standards describe a standard way to exchange clinical and nonclinical study data. These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables, identify appropriate controlled terminology and standard ways of doing calculations with common variables. 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.
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.
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- Providing Regulatory Submissions in Electronic Format – IND Safety Reports: Draft Guidance for Industry (October 2019) — This binding guidance describes the electronic format sponsors will be required to use when they electronically submit certain investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
- Providing Regulatory Submissions in Electronic Format - Standardized Study Data: Guidance for Industry (PDF - 136KB) (June 2021) - 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.
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data | FDA - The 21st Century Cures Act, signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the 21st Century Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this action, calling for FDA to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, FDA has created a framework for a program to evaluate the potential use of real-world data (RWD) to generate RWE to help support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support or satisfy post-approval study requirements (RWE Program).
Additional Relevant Guidances
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data (Oct 2021).
- Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance For Industry; Technical Specifications Document (Oct. 2019)
- Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry (Feb. 2020) - 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 v4.9 (March 2022) - This guide provides technical specifications, study data standardization plan, and general considerations on how to submit standardized electronic study data.
*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.* - Electronic Submission of IND Safety Reports Technical Conformance Guide (April 2022) — This guide provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
- Therapeutic Area Information & Specifications
The following section provides published specifications for additional information on study data submissions to CDER and CBER.- Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals, Guidance for Industry, Technical Specifications Document v. 1.0 (May 2021) - This document provides detailed information and specifications for the content of datasets that should be submitted as part of the sponsor’s or applicant’s submission for rodent carcinogenicity studies of pharmaceuticals in nonclinical studies. These specifications were built to support the standard data submission requirement for rodent carcinogenicity studies, and to reflect the data standards and processes described in the FDA Study Data Technical Conformance Guide.
- The technical specifications document Submitting Next Generation Sequencing Data to the Division of Antiviral Products v. 1.0 (July 2019) provides the current thinking of FDA’s Division of Antiviral Products regarding the submission of next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drug products.
- QT Studies Technical Specification Document v. 1.0 (PDF - 434 KB) - This document provides detailed information and specifications for the content of datasets that should be submitted as part of the sponsor’s/applicant’s application for drugs required to be assessed in clinical studies for their QT/QTc interval prolongation and proarrhythmic potential. These specifications also provide an opportunity for dialogue between the sponsor/applicant and reviewers to discuss issues with trial design or conduct that may affect the content of the analysis datasets.
- Bioanalytical Methods Validation (BMV) Tech. Spec. v1.0 (PDF - 121KB) - This guidance provides templates for summarizing bioanalytical methods used in clinical studies that should be provided as part of the applicant’s submission. The templates are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs).
- Human Immunodeficiency Virus
HIV Technical Specifications Guidance v. 1.0 (PDF – 296 KB) (March 2018) - This document provides detailed information and specifications for the content of data sets that should be submitted as part of the sponsor’s/applicant’s application for drugs intended to treat human immunodeficiency virus (HIV). These specifications also provide an opportunity for dialogue between the sponsor/applicant and reviewers to discuss issues with trial design or study conduct that may affect the content of these analysis data sets. These specifications were built to support the recommendations provided in the guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment” and reflect the data standards and processes described in the FDA Study Data Technical Conformance Guide. - Vaccines
Vaccines Technical Specification Guidance v2.1 - 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. - Comparative Clinical Endpoint Bioequivalence Studies
Clinical Endpoint BE Studies v1.0 – This document provides recommended technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for Abbreviated New Drug Applications (ANDAs) should be submitted using FDA-supported data standards located in the FDA Data Standards Catalog.
- Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) - This document provides detailed information and technical specifications for the data sets submitted to FDA as part of the sponsor’s/applicant’s application for drugs intended to treat noncirrhotic nonalcoholic steatohepatitis (NASH). These specifications are intended to support the draft guidance for industry Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment and reflect the data standards and processes described in the FDA Study Data Technical Conformance Guide. The focus of this document is to guide data submission for clinical trials related to treatment of noncirrhotic NASH and evaluation of drug-induced liver injury (DILI) in patients with noncirrhotic NASH. These specifications also provide an opportunity for dialogue between the sponsor/applicant and the Division of Hepatology and Nutrition to discuss issues related to trial design or conduct that may affect the content of these analysis data sets.
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:
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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 v1.5 (March 2021) are used by the FDA to ensure data are standards compliant and support meaningful review and analysis.
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.
- Recommendations for the Submission of LOINC Codes in Regulatory Applications to the U.S. Food and Drug Administration - Recommendations document prepared by CDISC with input from the LOINC Working Group members (FDA, National Institutes of Health (NIH), CDISC, and Regenstrief Institute) and submitted to the FDA. The FDA plans to review the Working Group document and provide recommendations in the Study Data Technical Conformance Guide.
- Guidelines for Requesting Waiver to Current Supported Clinical Study Data Standard Versions - To submit standardized study data using a standard that was previously supported, see the guidelines for requesting a waiver to current supported clinical study data standard versions.
Stay Connected
- For additional information/support from CDER, please contact [email protected].
- For additional information/support from CBER, please contact [email protected].
- For additional information/support from CDRH, please contact [email protected].