Specifications for Organizing Study Datasets

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)....

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FDA eCTD Submission Metrics, Role of Study Tagging Files

Announcement: See GlobalSubmit’s website for a brand new presentations page linking to recent agency presentations! GlobalSubmit recently attended two informative DIA conferences: The 8th Annual Electronic Submissions Conference “eCTD: The Adventure Continues” in San Diego The 10th Conference on European Electronic Document Management in beautiful Vienna, Austria During these conferences, industry received updates from a number...

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