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.

Additional Relevant Guidances

• 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.* 
• Bioresearch Monitoring Technical Conformance Guide (BIMO TCG) V3.0 (August 2022) — This Bioresearch Monitoring Technical Conformance Guide (BIMO TCG) provides current FDA specifications, recommendations, and general considerations for preparing and submitting Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and a Summary-Level Clinical Site Dataset that are used by the Center for Drug Evaluation and Research (CDER) for planning of Bioresearch Monitoring (BIMO) inspections in electronic format for new drug applications (NDAs), biologics license applications (BLAs), and NDA or BLA supplemental applications containing clinical data that are regulated by CDER. It also applies when these data and information are submitted under certain investigational new drug applications (INDs) in advance of a planned NDA, BLA, or supplemental submission.
• 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: 

• 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.