Ennov InSight RIM Publisher 7.1

eCTD Assemblies

Ennov InSight includes ICH-compliant eCTD templates. The assembly templates include all sections defined by the CTD/eCTD specification.

Folder types have been preconfigured to provide the metadata for specific headings in the eCTD that require additional information, for example: drug substance, drug product, excipients, clinical indication, and regional administrative information.

In Modules 4 and 5, only one sample study report is included in the first study report section. You should remove any sections that are not applicable to an individual submission. If you do not remove them, the published XML will include their corresponding elements. This XML will be valid against the DTD. However, these sections are not applicable and you should remove them prior to publishing for clarity per agency recommendations.

Typical ways to use the eCTD templates:
  • Create an assembly using a module 1 template, then import additional modules from the eCTD ICH Module 2-5 template.
  • Create a new template based on a module 1 template, with the eCTD ICH Module 2-5 template imported. You can subsequently create new assemblies using this template.
  • Create an assembly using the eCTD ICH Module 2-5 template, then import the module 1 folder from a module 1 template.

When performing an import of an existing eCTD, the import progress is reported in the server.log file. The Job Request Details also show messages about each sequence that is imported. The administrator can monitor the server log to follow the overall progress of the import and see more detailed messages, such as timestamps and Oracle information.

You can also create an eCTD assembly using the Create eCTD wizard.

While you are allowed to include more than one set of DTDs, you must be sure to include only one DTD of each type. For example, do not include two versions of an EU Module regional DTD. This may cause errors during publishing.