Use eCTD Templates

The eCTD templates include every leaf that can be included according to the ICH and regional specifications defined in the DTDs and the ICH granularity document.

You can easily modify the assemblies that use the template by deleting the unnecessary folders and leaf elements or adding additional leaf elements if more granularity is desired. Typical ways to use the eCTD templates include:

— Creating an assembly using the Create eCTD Wizard that is mapped to the Module 1 and eCTD ICH Module 2-5 template.

— Creating an assembly using a module 1 template, and then importing additional modules from the eCTD ICH Module 2-5 template.

— Creating a template based on a module 1 template, with the eCTD ICH Module 2-5 template imported and subsequently creating assemblies using this template.

— Creating an assembly using the eCTD ICH Module 2-5 template, and then importing the module 1 folder from an m1 template.

The following topics provide information about the specific eCTD templates provided with Ennov InSight .