Add Additional IRB/EC

Users can specify more than one IRB/EC for a site from within the Sites module of SSU. Proceed to the section Add Additional IRB/ECs for more details on this.

1. Click the IRB/EC Submission option on the IRB/EC Details page. This opens the IRB/EC Submission Page.
2. Click the drop-down arrow next to the Add button. The Create New and Create from Existing options are displayed.

   

3. Click the Create New option. The Create Package pop-up window is displayed.
4. In the Package Details tab, fill in the required fields – IRB/EC, and Package Name
5. Click the Next button at the bottom of the popup window.

   

6. This opens the Associate Sites tab, click on the + Associate Sites button.
7. The Associate Sites pop-up window is displayed.

   This section will cover the following features:

   • Status: Allows users to filter sites based on their selected status.
   • Country: Enables users to specify a country as needed.

   • Show Selected Only: A toggle button that displays only sites filtered by Status and Country.

   

8. Click Associate Sites, and the associated site is displayed within the Associate Sites tab.
9. Click on the Next button.

   

10. Locate the Site and click the Remove button. The associated site is removed from the Create Package.

    

11. This opens the Select Documents tab. Select an appropriate option – Browse Files OR Search Documents.
12. Click on the Browse Files option, select a document from the system, and click on Open.

    

    

13. The selected document is added to the Select Documents tab.

    

14. Once the document is uploaded, select the document click on the Edit Doc Name, make the required changes, and click the Tick mark beside the document.

    

15. Select the document and click Delete the button to discard the action.

    

16. Click the Search Documents tab the Search pop-up window is displayed.

    

17. Expand the All Libraries arrow to search from SSU Library or eTMF Library.

    

    

    Note: Some hints to get better search results:

18. Clicking the Advanced Search button in the search pop-up window redirects the user to the Advanced Search page.

    

19. Users can add unlimited fields as needed with the + Add More Fields button. The Advanced Search – Add Fields pop-up window is displayed.

    

20. Select the fields and click the Save button. The selected fields added to the Search page.

    

21. Click the Remove All option to remove the added fields.
22. Click Reset All resets the page with the existing information.

    

23. The Search pop-up window displays the below three tabs by default.
    • Metadata and Document
    • Document Content Only
    • Metadata Only

    Note: The Metadata and Document tab is pre-selected by default. Choose Document Content Only or Metadata Only if you want to filter the results accordingly.

    

24. Enter the document name in the Search field and click Search. The searched document is displayed with the Metadata on the left side.

    

25. Click the Document Content Only tab it will display the document based on the content only.

    

26. Click the Metadata Only tab it will display the document having metadata.

    

27. The users can view the views in two ways:

    • Grid View

    

    • Card View

    

28. Select the document and click Add Documents & Continue or Add Documents & Close button as per the requirement.

    

29. Click Add Documents & Close will close the Search pop-up window.
30. Click the Create button. The notification message is displayed on the top right side of the screen.