Date: 08-Oct-2026
Intelligence Overview
The U.S. Food and Drug Administration (USFDA) has published the Study Data Technical Conformance Guide, a technical specifications document supporting the submission of standardized study data in electronic regulatory submissions.
Developed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the guide provides technical recommendations to help sponsors prepare study data in formats that meet FDA submission requirements.
Key Highlights
- Study Data Standardization: Provides technical specifications for standardized nonclinical and clinical study data submitted to the FDA.
- Data Standards: Addresses data structures and standards, including the Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Standard for Exchange of Nonclinical Data (SEND).
- Submission Documentation: Covers supporting documentation, including the Study Data Reviewer’s Guide and data definition files.
- Technical Conformance: Describes data validation, conformance checks, and study data traceability to support regulatory review.
- Electronic Submissions: Supports compliance with applicable FDA requirements for standardized study data in regulatory submissions.
Regulatory Significance
The guide is a useful reference for regulatory affairs professionals, clinical data management teams, biostatisticians, and regulatory submission specialists involved in preparing electronic submissions to the USFDA. Following applicable technical specifications can help improve study data consistency, validation, and usability during regulatory review.
Source: https://www.fda.gov/media/153632/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document