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. The Amendments Management window opens in the right panel.

   

5. Click the Add button displayed at the top menu bar to open the Create Amendment window.

   

   1. Fill in the details as required.
   2. Click Add in the Required Documents panel in this window.
   3. The Required Documents window opens.

      

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