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 life cycle and non-life cycle )

— 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.

Null Value and Swiss eCTD Assemblies

When using the Create eCTD wizard to create a Swiss eCTD assembly, you are prompted for the number of Galenic Forms included in the sequence, the name of the form, and Swissmedic Number. A separate folder is created for each Galenic Form indicated in the resulting assembly and includes the value 'null' in the Name attribute.

You MUST edit the extended attributes of each folder to provide the Galenic Form's translation languages and values (the Galenic Language Name attribute pair).

You may also update the folder name to remove the 'null' value, but this has no effect on the published output. At least one Galenic Language Name pair must be provided in order to produce valid XML.

Create eCTD Submission

The Create eCTD wizard enables you to create, update, and organize structured and compliant eCTD assemblies.

Using standard templates, you can create folder structure, leaf elements, and metadata in an assembly.

To create an eCTD assembly:

1. Click a link for the sequence, assembly, standalone assembly, or assembly plan from which you want to create an eCTD assembly.
2. Choose Wizards > Create eCTD. The Create eCTD wizard appears.
3. Do the following:

   Option	Action
   In the Assembly Name box:	Enter a name for the assembly. For assembly plans, the name of the submission plan associated with the assembly plan is populated automatically as the name for the assembly.
   To import the TOC and special sheet values from the publication settings of the template on which you are basing the eCTD:	Select Copy TOCs and Special Sheets.
   From the Available countries box:	Select the appropriate countries and move them to the Selected box.
   To remove countries from the Selected box:	Select them and move them back to the Available box.
   Next to Template Selection:	Select the template on which to base the eCTD.

   Note: 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.

4. Click Next .

   The Select Attributes page appears. The region for which you are creating the eCTD determines the attributes that appear in the wizard. Enter details as necessary.

5. Click Next.

   The Set Application Metadata page appears. The type of assembly for which you are creating the eCTD determines the attributes that appear in the wizard. Enter details as necessary.

6. Click Next.

   The Select Sections page displays all of the available CTD sections you can add to the assembly.

7. Select the individual folders and subfolders for the eCTD.

   — For existing standalone, life cycle or non-life cycle sequence assemblies, any section folders that already exist in the assembly are not available.

   — Selecting a top-level section automatically includes all the subsections for that folder.

   — To update the metadata values in sections that already exist, or to add the subsections to existing sections, select the checkbox next to the existing sections that need to be updated

   Tip: Folders or leaves that are copied from the template appear in the same order as in template. New sections, folders or leaves that do not belong to any template are placed at the top of the list.

8. Click Next.

   The Select Sets of Submission Metadata page appears. If you have included any of the repeatable assembly sections, they are displayed.

9. Enter the number of sets of information for each repeatable section. In some instances, the metadata may be dependent on a section being created or on one that already exists.

   Note: When running the 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. This is because this code is always used when publishing.

10. Click Next.

    The Set Submission Metadata page appears.

11. Enter the submission metadata. For metadata descriptions, see Submission Metadata.
12. Click Next.

    The Confirmation page appears.

13. Click Next.

    The Summary page displays a message indicating that the eCTD information has been saved to the assembly.

14. Do one of the following:

Add Metadata to Assembly

Ennov InSight enables you to add metadata such as application number, cross-reference application details, sequence number, and submission ID to US DTD v3.3 submissions.

To add metadata to an assembly:

1. Navigate to the assembly to which you want to add metadata.
2. Expand the assembly tree and select the module level folder to which you want to add the metadata.
3. Click More > Add Metadata.
4. Select the metadata type from the drop-down list.
5. Enter relevant details in their corresponding fields.

   For an assembly plan with multiple applications associated to it, only one application containing files can be configured.

6. Save.

The metadata is added to the assembly. eCTD Attributes Australia

You can use the following attributes to describe eCTD submissions for Australia.