Submit eCTD 4.0 Publishing Request

An application with specific assembly components can be submitted for publishing.

You must be aware of the following limitations before submitting an electronic publishing request:

— All the eCTD 4.0 publish requests must be made from assemblies that have leaf elements. — Output is not generated for an eCTD 4.0 application published without leaf elements.

To submit eCTD 4.0 publishing request:

1. On the Assembly Attributes page, click .
2. On the Publish Request page, click Browse to choose the repository location to publish the submission.

   The folder for the published output should not contain both Unicode characters and spaces as this results in an invalid path error. If you are using Documentum as the repository location, move to the next step. Else, go to step 4.

3. Under Output Document Type, choose the document type.
4. Select Append Application and Sequence Number to create subfolders in the output location.

   Because Ennov InSight automatically appends the application number and sequence code to the folder path during publishing, you should always use legal file system characters in these attributes. The following characters are not legal on a file system: \ / : * ? " < > |.

   1. subfolder is created with the application name followed by the sequence number.
5. If you need to generate renditions for the assigned documents and overlays select Prepare to Publish.
6. Choose one of the following to indicate what should be published:

   Option	Description
   All Leaf Elements:	Publishes all the leaf elements in the assembly to individual output files.
   Selected Leaf Elements:	Publishes only those leaf elements that are included in the selected folder.
   All Leaf Elements and XML:	Publishes all the leaf elements in the assembly to individual output files. The eCTD XML backbone is published according to the appropriate CV Profile file.
   Selected Leaf Elements and XML:	Publishes only those leaf elements that are included in the selected folder. The eCTD XML backbone is published according to the appropriate CV Profile file.
   XML Only:	Publishes the eCTD backbone XML based on the appropriate CV Profile file. None of the leaf elements are published.

7. Under Include Leafs with Status, select the leaf statuses of the leafs you want to publish.

   By default, all active leaf statuses from Data Administration > Submission Maintenance section under Selected are selected. Clear the selection as appropriate The leafs with selected statuses are included in the electronic publish to generate output leaf files. This option does not affect the XML generation. For XML, all leafs are included, independent from the status assigned.

8. Under DMS Versioning Scheme, choose one of the following for the published output files:

   Option	Description
   Same:	Includes the same version number as previous output for the published output files. (Choose this when you are publishing to a file system.)
   Minor Version:	Includes increments to a minor version for the published output files.
   Major Version:	Includes increments to a major version for the published output files.

9. Click OK to submit a publish request.
   1. message confirms the publish request has been successfully sent.
10. Select Go To > Job Requests to view the status of your publication request.

Once the job is complete, navigate to the publish output location and confirm publication. The submission including submissionunit.xml is generated.