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USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications

Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center for Drug Evaluation and Research (CDER) released the final guidance on "Study Data Technical Conformance Guide - Technical Specifications Document" that document provides guidance on how to submit standardized study data using FDA-supported data standards, such as CDISC (Clinical Data Interchange Standards Consortium).

The purpose of this guide is to provide technical recommendations to sponsors on the submission of animal and human study data in INDs, NDAs, ANDAs, and BLAs in a standardized electronic format.

The guide covers topics such as:

  • The Study Data Standardization Plan (SDSP), describes on preparing an overall study data standardization plan, a study data reviewer’s guide and an analysis data reviewer’s guide.

  • The Exchange Format: Electronic Submissions details the specifications, considerations, and recommendations for the file formats.

  • The Study Data Submission Format for Clinical and Nonclinical provides general considerations and specifications for sponsors, eg: Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Standard for Exchange of Nonclinical Data (SEND).

  • The Therapeutic Area Topics explains the supplemental considerations and specific recommendations when sponsors submit study data using therapeutic area extensions of FDA-supported standards.

  • The Terminology section covers the controlled terminologies/vocabularies for clinical trial data or nonclinical study data.

  • Electronic Submission Format provides specifications and recommendations on submitting study data using the eCTD format.

  • Study Data Validation and Traceability detail the recommendations on conformance to standards, data validation rules, data traceability expectations, and legacy data conversion.

By following the guide, sponsors and researchers can ensure that their study data submissions are technically compliant and consistent with FDA expectations. By following the guidance, you will ensure that your study data submissions are technically compliant and consistent with FDA expectations.


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