The Study Data Technical Conformance Guide (SDTCG) from the USFDA provides a framework to help sponsors submit standardized study data effectively. This document, updated in October 2024, complements the FDA's "Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Standardized Study Data" by offering technical specifications and recommendations.
The SDTCG is designed to assist sponsors by providing specifications for standardized data submissions. The guide aims to enhance data standardization in regulatory submissions, ensuring data consistency and quality for clinical and nonclinical studies.
Study Data Standardization Plan (SDSP): Sponsors are encouraged to include an SDSP early in the development phase. The SDSP outlines the plan for submitting standardized study data to the FDA and helps the agency anticipate data challenges.
Reviewer’s Guides (RGs): For each submission, a Study Data Reviewer’s Guide (SDRG) for clinical and nonclinical data and an Analysis Data Reviewer’s Guide (ADRG) for clinical data are recommended.
The SDTCG details requirements for file formats used in electronic submissions:
XML (Extensible Markup Language): Used in documents like define.xml, XML ensures structured, machine-readable data.
PDF (Portable Document Format): Standardized for documents, such as case report forms (CRFs) and other necessary records.
XPORT (SAS Transport Format): This is the required format for electronic datasets. Datasets should generally be limited to a size of 5 GB to facilitate processing.
The guidance also covers applying Clinical Data Interchange Standards Consortium (CDISC) standards:
SDTM (Study Data Tabulation Model): Used for structuring clinical data.
SEND (Standard for Exchange of Nonclinical Data): Applied to nonclinical study data.
ADaM (Analysis Data Model): Used to prepare analysis datasets, especially for clinical studies.
Each dataset should include key identifiers, such as the unique subject identifier (USUBJID) and subject identifier (SUBJID), to maintain data consistency across studies and applications.
The guide includes appendices covering various technical aspects, such as data standards and file structure examples. Each appendix provides detailed instructions on issues like creating trial summary (TS) parameters and technical rejection criteria for study data validation.
For more details, the full Study Data Technical Conformance Guide can be accessed through the FDA’s official link.
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