Ennov InSight RIM Publisher 7.1

Create eCTD Wizard

The Create eCTD wizard enables you to create and organize structured and compliant eCTD assemblies. Using standard templates, you can create folder structure, leaf elements, and metadata in an assembly.

You can run the wizard multiple times to ensure the metadata is up to date, to add new sections, or to refresh structures. The eCTD wizard shows all eCTD components that are available for inclusion in the submission.

The eCTD wizard enables you to perform the following tasks:
  • Create the assembly for the first sequence or a standalone assembly.
  • Build the assembly with the correct eCTD components based upon region, specifications, template, configuration, and user selections.
  • Create the assembly structure with selected or confirmed metadata.
You can use the Create eCTD wizard with:
  • Existing standalone assemblies
  • Existing sequence assemblies (both lifecycle and non-lifecycle)
  • Existing sequences with no assembly created
  • Applications or events

Using the Create eCTD Wizard, you can select a template other than the default template to use with the assembly, and that selected template will persist as the default whenever you run the Create eCTD Wizard for that assembly.

When you create an eCTD using the wizard, all attributes display the default values from the assembly template you are using. The assembly templates provide all available sections for an eCTD.

Automatically, each leaf element created using the Create eCTD Wizard is assigned the default Leaf Status value configured in Data Administration.

Based on the module you select (US, Canada, Europe. Switzerland, Japan, Rest of World), some of the properties are different. For example, United States does not require a country.

When creating an eCTD from an existing sequence and application, the region, application number, sequence number, and countries attributes are pre-populated based on the information stored in those entities.

When running the Create eCTD wizard for a new standalone assembly, the regions available for selection in the Region drop-down list are all active regions of the Regulatory Region type. The list is alphabetically sorted.

When running the Create eCTD wizard, or editing the M1 or envelope folders:
  • The current sequence code for the sequence entity is always updated in the eCTD metadata in the folder extension.
  • The sequence code is always used when publishing.