Publish Elements in eCTD Templates

The publishing elements are designed to facilitate the production of CTD paper and Non-electronic eCTD (NeeS). The folder and leaf types that you assign in an eCTD assembly are based on the current ICH and regional eCTD specification. These element types enable you to record eCTD-specified metadata attributes.

The eCTD templates also include sample publishing elements, including tables of contents, cover pages, slip sheets, tabs, overlays, and all applicable publishing settings.

In addition, the E3 Clinical Study Report template contains the elements necessary to generate a standard CSR publication.