Review and confirm countries for EU submission validation or Part 1 package

Study level submission approval activities for both the EU submission validation package and the Part 1 package require users to review and confirm approved countries.

  1. Open the EU submission validation or Part 1 modal and click Review and confirm countries.
  2. The Review and confirm countries modal opens and displays the Reporting member state in a drop down list and countries approved from the submission in a check box list.
  3. The Approve reporting member state check box will be checked (enabled) by default. If this is incorrect, uncheck the check box.
  4. Check or uncheck the check boxes for each country listed under Countries approved from this submission. A country with a checked box is approved, while a site with an unchecked box is not.
  5. Click Done.