IRB Approval: Submission Packages

Simplify and streamline regulatory submissions with our latest SSU enhancement, now supporting IRB and Ethics Committee (EC) submission packages throughout the study lifecycle. This feature extends SSU’s powerful submission tracking and management beyond Health Agencies, ensuring seamless approvals at every level.

• Expanded Submission Packages: Now create and manage IRB/EC submission packages, directly linking them to relevant sites.
• Intelligent Site-Level Approvals: When approving a submission package, users can select specific sites that have received approval, ensuring precise tracking.
• Flexible Approval Workflow: Easily approve all or select sites within a submission package, with approvals automatically cascading down to the site level.
• Global Submission Efficiency: In the European Union, a single submission package can now be assigned to multiple countries, reducing redundancy and streamlining multi-country studies.
• Multi-Country Assignments: Users can now assign multiple countries directly from the submission package profile tab, ensuring efficient global coordination.
• Automated Country-Level Updates: When a submission package is linked to multiple countries, it automatically appears in each country's records, eliminating duplication.
• Real-Time Status Synchronization: Changes in the submission package status instantly reflect across all associated countries, ensuring accurate and up-to-date regulatory tracking.