FDA's Technical Conformance Guide for Study Data

The Technical Conformance Guide provides specifications, recommendations, and general considerations to sponsors and applicants on how to submit study data in a standardized electronic format (i.e. using FDA supported data standards). The guide supplements FDA's guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data (eStudy Data guidance). It implements the electronic submission requirements with respect to standardized study data contained in (investigational) new drug applications.

Standards for the Submission of Study Data

According to the agency, the technical guide is intended to complement and promote interactions between sponsors and FDA review divisions. However, it is not intended to replace the need for sponsors to communicate directly with review divisions regarding implementation approaches or issues relating to data standards. In particular, it presents general considerations and specifications for sponsors using, for example, the following standards for the submission of study data:

  • Study Data Tabulation Model (SDTM),
  • Analysis Data Model (ADaM),
  • Standard for Exchange of Nonclinical Data (SEND).

Moreover, sponsors should include a plan (e.g., during the early stages of product development) describing the submission of standardized study data to FDA. This Study Data Standardization Plan (SDSP) assists FDA in identifying potential data standardization issues early in the development program.

More information is provided in FDA's Study Data Technical Conformance Guide - Technical Specifications Document.

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