New FDA Study Data Specifications Differentiate Between SDTM, Legacy Formats

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In January, FDA issued version 1.5.1 of Study Data Specifications. As discussed in my previous blog entry, a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered to indicate whether they were STDM or legacy format. The new specifications for organizing study datasets and their associated files in folders are summarized in the following figure. In the document, an accompanying table provides further definition of the folders.

This was all developing in a fairly straightforward way until ICH issued a new set of valid values. this updated included new file tags for:

  • data-tabulation-dataset-legacy
  • data-tabulation-dataset-sdtm
  • data-tabulation-dataset-send

Well, the first two are fine but where in the above structure would you put SEND (Standard for Exchange of Nonclinical Data)? Look for the FDA to issue an update of the spec to address this issue.

In the meantime, don’t panic. The FDA has not implemented the new version yet. No specific date has been determined as to when FDA will implement the new values so it could take several months.  Sponsors should not use the new valid-values until FDA accepts them and has them posted on their web site.

Author: GS

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