Use the Bulk eCTD Import Wizard

You can use the Bulk eCTD wizard to import multiple submissions to a supported document management system.

1. In Calyx RIM, open the Wizards menu and select Bulk eCTD Import.
2. In the Publishing Settings Library field, select the Publishing Settings Library Template (PLT) to create Assembly Specific Publishing Settings Libraries (APL) for the imported eCTDs.
   This field is applied according to the following rules for new or existing applications:

   • New Application – If the import is to a new Application (there are no existing Sequence Assemblies) then the Publishing Settings Library Template selected in this field is the APL for the imported Sequences.
   • Existing Application – If the import is to an existing Application (there are existing Sequence Assemblies) then the eCTD Import uses the Submitted View from the previous existing Sequence as the basis for the APL for the imported Sequences.
3. On the Import Location field, click Browse to locate source of the eCTDs to import.
4. Select the folder containing all Applications with their nested eCTD sequences.
   It is prerequisite to have collected all eCTD imports into one folder.
5. In the Import Orphan Leaf Elements field:
   • Select Yes to include orphan leaf elements in the import.
   • Select No and Calyx RIM ignores orphan leaf instances and instead creates new leaf elements.
6. In the Import Leaf Elements Only field:
   • Select Yes to import only the XML leafs in the eCTD XML, without importing references to the content files.
   • Select No if extracts and renditions are needed for the imported documents. You can run Create Renditions and Extractions from each assembly.
     Note: Each imported leaf element is automatically assigned with the Published leaf status, or any other leaf status that has the Internal System Status set to "PUBLISHED".
7. In the Use Application Code for Prefixes field:
   • Select Yes to use the existing application codes as prefixes.
   • Select No to enter a new Sequence Prefix and Assembly Prefix.
8. In the Create Grouping Event field:
   • Select No (the default), and no grouping event is created.
   • Select Yes and use the default (Legacy Submissions) or enter a different Event Name.
9. If Create Grouping Event is Yes, the Close Event as Approved field appears. In the Close Event Approved field:
   • Select No to keep the Event open, it will not be closed.
   • Select Yes to close the Event with the status Approved. If Yes is selected, the Event Name field is created and required (limit 200 characters). The Event Name default is Legacy Submissions. If any submissions failed to import, the Event is not closed.

   On import, all Sequences are associated with the defined Event and the Application. If any of the imported sequences already exist in the Application, they are not added to the defined event.

   If set to No, all Sequences will only be associated with the Application

   When imported:

   • If an Event with the same name already exists and is not closed, the sequences are added to that Event. The Status Date of the Event is not updated.
   • If more than one Event with the same name already exists and is not closed, the sequences are added to the most recent open Event, according to the creation date.
   • If an Event with the same name already exists and is closed, a new Event is created with the same name and a sequential number added as a suffix. New sequences are added to this Event

   For each country on the Application, an Event-Country is created. The Status is set to the default Event status. The Status Date is set to the date of import.

   Note: Because many regions do not contain a submission date, and in some regions the submission date is dropped between specifications, it is not possible to obtain a valid date for all eCTD regions.
10. Click Next, and the system parses the XMLs to determine the Application Codes.
    The Application Codes are matched to the Application Codes within Calyx RIM, and the system imports the eCTD structures. The Summary window displays this message: “The bulk eCTD import has been scheduled successfully. Choose Go To > Job Requests for the status.”
11. Click Finish.