Comparing Legacy, Granular Structures for Clinical Study Reports

As most people who work with eCTD are aware, agencies will accept clinical study reports structured in one of two ways: The “Legacy” format where the study report body and appendices, exclusive of datasets and CRFs, are combined into a single PDF. In some cases, the PDF has to be subdivided in order to remain within the ICH file size limit of 100 MB. The “Granular” or “E3” format, where the study report, especially the appendices, are...

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