Creating Amendments

To create amendments, the administrator needs to do the following:

1. Navigate to Settings.
2. Click the arrow next to Required Documents in the left panel.
3. Select Amendments from the dropdown.
4. On the Amendments Management window, click on the +Add button.

   

5. Fill in the details as required.
6. Click Add in the Required Documents panel in this window.

   

7. The Required Documents window opens.
   • • From the Required For dropdown in the left panel, select an option as required (All Sites, Specific Site, Specific IRB/EC, or Specific Country).
     • From the right panel above, in the ‘Provided by’ section, select a radio button.
     • Below in the right panel, select the required documents that are needed after the site activation.
     • Select an appropriate option from the dropdown menu of the ‘To be Submitted by’ and ‘Languages’ fields.
     • Click the ‘Add’ and ‘Close’ button to reflect the changes in the ‘Create Amendment’ window.
     • The procedure to add the documents is the same as described in the earlier section of Basic Configuration for SSU.

   

8. Click the Create button to create the amendment.