19.03.2015

FDA updates Study Data Technical Conformance Guide

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The U.S. Food and Drug Administration has released a new version 2.1 of the "Study Data Technical Conformance Guide", dated March 2015.

The new version 2.1 takes into consideration comments that were received to version 2.0 (released in December 2014). As a consequences the following sections were updated:

  • 2.2 Study Data Reviewer’s Guide (SDRG)
  • 2.3 Analysis Data Reviewer’s Guide (ADRG)
  • 3.3.1 SAS Transport Format
  • 3.3.2 Dataset Size
  • 4.1.4.5 Data Definition File

The "Study Data Technical Conformance Guide" can be downloaded from the "Study Data Standards Resources" site of the FDA.


[Source: FDA website]

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