FDA Data Standards Catalog and Reference File Download Link
https://eu2.contabostorage.com/00f3241116844f24b628f46d81abb929:st1/folder7/7354/1656292621_umc_org___us_fda_data_standards_catalog_v_xlsx_-_Standar_Format.xlsx
2026-05-31 02:00:16 - Admin
<style> body { font-family: Arial, Helvetica, sans-serif; line-height: 1.6; margin: 0; padding: 0; background-color: #f9f9f9; color: #333; } header { background-color: #004b87; color: #fff; padding: 20px; text-align: center; } nav { background-color: #e2edf7; padding: 10px 20px; } nav a { margin-right: 15px; color: #004b87; text-decoration: none; font-weight: bold; } main { max-width: 960px; margin: 30px auto; padding: 0 20px; background-color: #fff; border-radius: 5px; box-shadow: 0 2px 5px rgba(0,0,0,.1); } h2 { color: #004b87; margin-top: 30px; } ul { margin-left: 20px; } table { width: 100%; border-collapse: collapse; margin: 20px 0; } th, td { border: 1px solid #cdd7e0; padding: 8px; text-align: left; } th { background-color: #e2edf7; } a { color: #0066cc; } </style> <header> <h1>FDA Data Standards Catalog</h1> <p>A comprehensive guide to the data standards used by the U.S. Food and Drug Administration</p> </header> <nav> <a href="#what">What Is It?</a> <a href="#purpose">Purpose & Benefits</a> <a href="#structure">Structure</a> <a href="#key-standards">Key Standards</a> <a href="#how-to-use">How to Use</a> </nav> <main> <section id="what"> <h2>What Is the FDA Data Standards Catalog?</h2> <p>The FDA Data Standards Catalog (DSC) is a publicly available, searchable repository that documents the data standards the agency has adopted for regulatory submissions, internal data exchange, and public health reporting. It aggregates standards from multiple domainsclinical, laboratory, product labeling, adverse events, and moreinto a single reference point for industry, researchers, and FDA staff.</p> <p>Each entry in the catalog describes the standards name, version, governing body, applicable submission types, implementation status, and links to the official specifications or implementation guides.</p> </section> <section id="purpose"> <h2>Purpose & Benefits</h2> <ul> <li><strong>Consistency:</strong> Ensures that data submitted to the FDA follows a uniform format, reducing processing errors and accelerating review cycles.</li> <li><strong>Interoperability:</strong> Facilitates data exchange between FDA centers, industry partners, and other government agencies.</li> <li><strong>Transparency:</strong> Provides a single source of truth for all FDArequired and recommended data standards.</li> <li><strong>Regulatory Alignment:</strong> Helps sponsors align their data collection and submission processes with the latest regulatory expectations.</li> <li><strong>Futureproofing:</strong> Tracks revisions and upcoming standards, enabling proactive planning for system upgrades.</li> </ul> </section> <section id="structure"> <h2>Structure of the Catalog</h2> <p>Entries are organized into three main categories:</p> <ol> <li><strong>Regulatory Submission Standards</strong> Standards that must be used for specific FDA submission types (e.g., CDISCADaM for clinical trial data, FDAAASE for adverse event reporting).</li> <li><strong>Reference Standards</strong> Widely accepted standards that support regulatory activities but are not mandatory (e.g., HL7 FHIR, ISO8601 for datetime formats).</li> <li><strong>Internal Agency Standards</strong> Standards developed or customized by FDA for internal data management (e.g., FDAs own product code numbering system).</li> </ol> <p>Each catalog record contains the following fields:</p> <table> <thead> <tr> <th>Field</th> <th>Description</th> </tr> </thead> <tbody> <tr> <td>Standard Name</td> <td>Official title of the standard.</td> </tr> <tr> <td>Version / Release</td> <td>Current version and date of release.</td> </tr> <tr> <td>Governing Body</td> <td>Organization that maintains the standard (e.g., CDISC, ISO, HL7).</td> </tr> <tr> <td>Applicable Submissions</td> <td>FDA submission types that require or recommend the standard.</td> </tr> <tr> <td>Status</td> <td>Implementation status (e.g., Mandatory, Recommended, Optional).</td> </tr> <tr> <td>Reference Links</td> <td>Direct URLs to the standard specification, implementation guide, or FDA guidance.</td> </tr> </tbody> </table> </section> <section id="key-standards"> <h2>Key Standards Frequently Encountered</h2> <h3>Clinical Data</h3> <ul> <li><strong>CDISC SDTM (Study Data Tabulation Model)</strong> Organizes raw clinical trial data for submission to FDAs Center for Drug Evaluation and Research (CDER).</li> <li><strong>CDISC ADaM (Analysis Data Model)</strong> Provides a consistent structure for analysis datasets used in statistical reporting.</li> <li><strong>HL7 FHIR (Fast Healthcare Interoperability Resources)</strong> Enables electronic health record (EHR) data exchange in realtime; increasingly referenced for realworld evidence submissions.</li> </ul> <h3>Laboratory & Toxicology</h3> <ul> <li><strong>ISO 15189</strong> Specifies requirements for quality and competence in medical laboratories.</li> <li><strong>NIH/NCI caDSR (Cancer Data Standards Repository)</strong> Used for oncology trial data elements.</li> </ul> <h3>Product Labeling & Packaging</h3> <ul> <li><strong>FDA Structured Product Labeling (SPL)</strong> XMLbased format for the content of prescription drug labeling.</li> <li><strong>GS1 Global Trade Item Number (GTIN)</strong> Standard for uniquely identifying products throughout the supply chain.</li> </ul> <h3>Adverse Event Reporting</h3> <ul> <li><strong>FDAAASE (Adverse Event Reporting Standard for Electronic Submissions)</strong> Enables electronic transmission of adverse event data via the FDAs FAERS system.</li> <li><strong>ICSR (Individual Case Safety Report) XML</strong> Preferred format for pharmacovigilance submissions.</li> </ul> </section> <section id="how-to-use"> <h2>How to Use the Catalog</h2> <p>Below is a stepbystep guide for sponsors and developers who need to locate and apply the appropriate standards.</p> <ol> <li><strong>Access the Catalog</strong> Visit the FDAs official Data Standards Catalog page (typically hosted under <a href="https://www.fda.gov">fda.gov</a>).</li> <li><strong>Search or Filter</strong> Use the quicksearch bar for keyword queries or apply filters by domain, governing body, or status.</li> <li><strong>Review the Record</strong> Click a standard name to view the detailed record, including version history and links to the official specification.</li> <li><strong>Determine Applicability</strong> Crossreference the Applicable Submissions field with your submission type (e.g., NDA, IND, PMA).</li> <li><strong>Download Resources</strong> Follow the reference links to obtain the complete standard document, implementation guides, or FDA guidance PDFs.</li> <li><strong>Implement in Your Workflow</strong> Incorporate the standards data structures, naming conventions, and validation rules into your data collection and submission pipelines.</li> <li><strong>Stay Updated</strong> Subscribe to the FDAs mailing list or RSS feed for catalog updates to capture new releases or deprecations.</li> </ol> <p>Many FDA centers also provide example datasets and validation tools. For instance, CDER offers an <a href="https://www.fda.gov/regulatory-information/standards-and-guidances/clinical-data-submission">online validator</a> for SDTM and ADaM files.</p> </section> </main>