eCTD 4.0 Templates

Use eCTD 4.0 templates to organize tree structure to conform to the ICH and regional specifications defined in the Сontrolled Vocabularies (CV) and the lists of headings provided by agencies. Most of the headings have a direct mapping to Context of Use codes.

With eCTD 4.0 templates, you can organize and include granularity by deleting unnecessary folders and leaf elements or adding additional leaf elements. Typical ways to use the eCTD 4.0 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 4.0 ICH Module 2-5 template.

— Creating a template based on a module 1 template, importing eCTD 4.0 ICH Module 2-5 template and subsequently creating assemblies using eCTD 4.0 template.

— Creating an assembly using the eCTD 4.0 ICH Module 2-5 template, and then importing the module 1 folder from an m1 template.

The following topics provide information about specific eCTD 4.0 templates provided with Ennov InSight : — eCTD 4.0 Template Files

— Assembly Templates and Controlled Vocabulary Dependencies

— Module 1 eCTD 4.0 Regional Templates