Define an EU submission validation package

To create and manage study level EU submissions in Oracle Site Activate, begin by defining the validation package.

1. Open an EU submission validation package modal and click Plan the Submission Package to open the planning modal.
2. Select the Reporting member state from the drop-down list.
3. Select a date for Define package date.
4. Enter the name of the Super User.
5. Select yes or no for Submitting part 1 and part 2 together.
6. At Concerned member state, choose the member state(s) to include in the validation package. You can filter the list to search for a specific state, select all, or multi-select several states.
7. 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.
8. If you clicked Continue, the package planning modal’s Study section displays. Choose the study documents you want to include in the validation package. Confirm that the Selected panel to the right lists the documents you chose.
9. Click Done and click Confirm.