Specifications for Organizing Study Datasets

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A few months ago, FDA issued version 1.5.1 of Study Data Specifications. Although the changes in the new version were not great, they were significant for eCTD as 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 and has no effect on the Table of Contents that is visible to a reviewer (created from the eCTD XML backbone).

The specifications for organizing study datasets and their associated files in folders are summarized in the following figure. No additional subfolders are needed; unused folders do not need to be supplied. In the document, an accompanying table provides further definition of the folders.

The problem that this is causing in the short term is that current publishing tools are not set up to produce this structure. Looking at the folder structure required in the previous specification:

You will see an important difference: tabulations must be assigned to a folder based on whether they are STDM datasets or legacy format. The problem is that most publishing tools don’t “know” which of the formats are being used, and aren’t prepared to create and populate the legacy and sdtm folders.

A second difference is that there is now a separate folder for datasets under analysis, where previously analysis datasets were placed directly in the analysis folder.

So where does that leave sponsors? I see three main options:

  • Demand an upgrade from your publishing vendor. Of course, that’s easier said than done as the vendor may not be prepared to provide this upgrade for the software version that the sponsor is using. Even if the vendor can provide a hotfix, the sponsor has to undergo all the agony associated with introducing the update into their validated environment.
  • Manually update your folders and patch your XML. Ugh – never a great idea. If you do this make sure you update your checksums and have a good validation tool!
  • Approach the FDA about a waiver.

I would be interested in hearing about what approach people are taking.

Author: GS

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