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...

Read More

eCTD Cross Application Links

A little while ago, a client asked me about referencing documents submitted in one application from another application. Her question was in the context of an IND and an NDA, both submitted in eCTD format – did she have to re-submit documents in her NDA that had already been submitted in her IND? The ICH guidance is basically silent on this subject, although the structure does not specifically prohibit any valid relative link....

Read More