Adding Sites

Follow the steps below to add the site:

1. Click the drop-down arrow beside the Add button.
2. Click the Add button. The Create Site pop-up window is displayed.

   

3. Fill in all the required fields within the Site Information tab and click the Next button.

   

4. The Contacts tab is displayed on the Create Site pop-up window.
5. Click the Add Existing button. The Add Existing Contacts pop-up window is displayed with the list of contacts.

   

6. Select the contacts and click Add Contacts button at the bottom of the Add Existing Contacts pop-up window.
7. The selected contacts get added to the Contacts tab.

   

8. Click the Create button on the Create Site pop-up window.

   

9. The Create Contact pop-up window is displayed with the Cancel, Save and Create Another, and Add buttons.
10. Fill in all required fields in the General Information, Contact Information, and Additional Information sections.
11. Click Add to save the contact, or click Save and Create Another to save the current contact and add a new one, and Cancel to discard the changes.
12. The newly added contact will appear on the Contacts page.

    

    

13. Locate the contact and click the Edit button.

    

14. The Edit Contact pop-up window is displayed. Edit the required fields and click the Save button.
15. Locate the contact and click the Remove button. The selected contact disappears from the page, and you click the Next button.

    

16. The IRB/EC tab is displayed on the Create Site pop-up window.
17. Click the Add Existing button. The Add Existing IRB/EC pop-up window is displayed with the list of the IRB/ECs.

    

18. Select the IRB/EC from the list and click the Add IRB/EC button at the bottom of the Add Existing IRB/EC pop-up window.
19. The selected IRB/EC displays on the Create Site page.

    

20. Click the Create button on the Create Site pop-up window.

    

21. The Create IRB/EC pop-up window is displayed with the Cancel, Save and Create Another, and Create IRB/EC buttons.
22. Fill in all required fields in the General Information, IRB/EC Contact Information, Additional Information, Meeting Frequency, and Submission Deadline sections.
23. Click Create IRB/EC if the user wants to create it, or click Save and Create Another to save the current IRB/EC and add a new one, and Cancel to discard the changes.
24. Click Create IRB/EC, the notification message ‘IRB/EC Created’ is displayed on the top right side of the screen.

    

25. Locate the IRB/EC with the type as Local and click the Set as Central button. The type of the selected IRB/EC changes to the Central.

    

    

26. Locate the contact and click the Remove button. The selected IRB/EC disappears from the page.

    

27. Click the Next button. The Required Documents page is displayed on the Create Site pop-up window.
28. Click the Add button. The Add Required Document Types screen is displayed.

    

29. Select the necessary document from the list, determine whether it is required for Site Activation or inclusion in the eTMF, and click the Save button.

    

30. The added document is displayed on the Create Site page.
31. Locate the contact and click the Remove button. The selected Document Type disappears from the page.

    

32. Click the Next button. The Amendments page is displayed on the Create Site pop-up window.

    

33. Locate the Amendment and click Set Applicable. The Applicable word is displayed right below the selected Amendment.

    

    

34. Locate the amendment and click Set not Applicable. The selected amendment is set to not applicable, and the word Applicable disappears.

    

35. Click the Next button. The Review & Confirm page is displayed on the Create Site pop-up window.
36. Ensure by reviewing the information is added while creating the site and clicking the Create button.
37. The notification message ‘Site has been successfully created’ is displayed on the top right side of the screen.