US: FDA releases new version 1.5.1 of the Study Data Specifications

The US Food and Drug Administration (FDA) released a new revision 1.5.1 of the Study Data Specifications applicable for submitting animal and human study datasets in electronic format.

Besides minor technical corrections, the changes introduced in version 1.5.1 include a modified directory tree structures for organizing datasets:

• A new subfolder "datasets" has been introduced as a subfolder of the "analysis" folder for (in addition to the "programs" folder)
• Subfolders "legacy" and "sdtm" have been introduced as subfolders of the "tabulations" folder. Tabulations not formatted according to an identified standard format (e.g. non-SDTM datasets) are to be located in subfolder "legacy", SDTM tabulations in the corresponding subfolder "sdtm"

Version 1.5.1 of the Study Data Specifications is available for download from the FDA website (see link below).

[Source: FDA website]

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