SSU IRB Submission Packages

- SSU supports creating, tracking and managing Submission Packages for Health Agencies. However, submissions are required to be made to IRBs and Ethics Committees throughout the lifecycle of the Study.

With this enhancement, SSU will expand the concept of Submission Packages to IRBs/ECs.

• The system shall allow creating of Submission Packages for IRBs associating them with Sites.
• The Submission Packages shall have different status.
• When approving the Submission Package, the system shall prompt the User to identify the Sites for which the approval has been received.
• The system shall allow approving all or some Sites associated with the Submission Package
• Approval for submission packages shall trickle down to sites IMPROVEMENTS SUBMISSION PACKAGES

In the European Union, a single submission package is created that is used for multiple countries. This new feature provides a way to assign a submission package to multiple countries.

• When creating a submission package, or when editing it, the User has the ability to assign multiple countries in the submission package profile tab.
• When multiple countries are chosen, this submission package automatically shows in each of those countries.

When the status of the submission package is changed, it automatically shows the status for all the countries associated with that submission package.