Define an EU submission Part 2

Define Part 2 after defining Part 1. When defining Part 2, you’ll choose study and country level documents, sites (Principal investigators), and site level documents.

1. Open EU submission Part 1 modal and click Plan the Submission Package to open the planning modal.
2. The Reporting member state and Concerned member states automatically populate the package’s Define section from the associated validation package. You may edit the values as necessary and the Selected panel updates reflect your new selections.
3. Select a value for Define package date.
4. Click the Save activity button to save your progress without completing the activity. Click the Continue button to save all selections and display the study level document options.
5. If you clicked Continue, the Study section displays. Use the check boxes to select the study level document(s) you want to include in the EU submission Part 2.
6. Click the Save activity button to save your progress without completing the activity. Click the Continue button to save all selections and display the country level document options.
7. If you clicked Continue, on the left side of the screen, click the country you want to define. In the center panel, click the Select country documents tab, if necessary. Use the check boxes to select the country document(s) you want to include in the EU submission Part 2. The Selected panel on the right side of the screen updates to reflect your selections.
8. In the center panel, click the Select sites tab and use the check boxes to select the principal investigators (sites) you want to include in the EU submission Part 2.
9. In the center panel, click the Select site documents tab and use the check boxes to select the site level documents you want to include in the EU submission Part 2.
10. If the country you defined is ready for submission, in the Selected panel, click the Ready for submission check box for that Reporting or Concerned member state country.
11. Repeat steps 7 and 8 for each country, as applicable. If appropriate, click the All countries are ready for submission check box below the Save and close button.
12. When all countries are marked as ready for submission, the modal’s Save and close button will be replaced by a Complete activity button.
13. Click Complete activity and click Confirm.