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.

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:
   • 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.
   • Select Copy TOCs and Special Sheets to import the TOC and special sheet values from the publication settings of the template on which you are basing the eCTD.
   • 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, lifecycle or non-lifecycle 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 that are copied from the template appear in the same order as in template. New sections or folders 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 descriptions of the metadata, 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:
    • To view the assembly that was created, click the first assembly link.
    • To start the Create Study Reports wizard for the assembly, click the second assembly link.
    • Click Finish to close the wizard.