Data Migration Documentation

Post-Migration Tasks for Calyx RIM 6.0

Defining Application Types Under Filing Type eCTD Code for Grouped Submissions

You can define the US FDA eCTD Module 1 Specification v2.3 / DTD v3.3 Grouped Submission application types using Filing Type Values in the Sequence Maintenance section in Data Administration.
Note: The procedure must be performed after the migration scripts have been completed. 
To define the application types for grouped submissions:
  1. On the Calyx RIM application home page, click Go To > Data Administration
  2. Under Sequence Maintenance, click Filing Type Values.
  3. Click Annual Report Filing.
  4. Under Applicable DTD/Schema, click us-3-3.
  5. In the Types Valid for Grouped Submissions box, select Investigational New Drug.
  6. Click >> to move Investigational New Drug to the Selected box.
  7. Click Save and then click Back.
  8. Click CMC Supplement.
  9. Under Applicable DTD/Schema, click us-3-3.
  10. In the Types Valid for Grouped Submissions box, select Abbreviated New Drug Application, Biologic License Application and New Drug Application.
    To select multiple application types simultaneously, press the Ctrl key and click the left mouse button.
  11. Click >> to move the selected application types to the Selected box.
  12. Click Save and then click Back. 
  13. Click Efficacy Supplement.
  14. Under Applicable DTD/Schema, click us-3-3.
  15. In the Types Valid for Grouped Submissions box, select Biologic License Application and New Drug Application.
  16. Click >> to move the selected application types to the Selected box.
  17. Click Save and then click Back. 
  18. Click Labeling Supplement.
  19. Under Applicable DTD/Schema, click us-3-3.
  20. In the Available for Application Types box, select Abbreviated New Drug Application, Biologic License Application and New Drug Application.
  21. Click >> to move the selected application types to the Selected box.
  22. Click Save and then click Back. 
  23. Click Product Correspondence.
  24. Under Applicable DTD/Schema, click us-3-3.
  25. In the Types Valid for Grouped Submissions box, select Abbreviated New Drug Application, Biologic License Application, Drug Master File (DMF), Investigational New Drug and New Drug Application.
  26. Click >> to move the selected application types to the Selected box.
  27. Click Save and then click Back.
  28. Click Promotional Labeling Advertising.
  29. Click us-3-3 under Applicable DTD/Schema.
  30. In the Types Valid for Grouped Submissions box, select Abbreviated New Drug Application, Biologic License Application and New Drug Application.
  31. Click >> to move the selected application types to the Selected box.
  32. Click Save and then click Back.
    The defined application types will be available for selection while creating submission plans for grouped submissions.