Setting IRB/EC Documents at Country Level

Follow the steps below to set the IRB/EC documents at the Country level:

1. In the Settings module, select the IRB/EC specific from the list within the Required Documents section.
2. Click the + Add button within the Document Types section the following radio buttons:
   • Site
   • Study
   • Country
3. Select the Country radio button that will show country-level documents in the Required Documents modal window.
4. Select the documents and enable the Site Activation in the Required For section.
5. Click the Save & Close button.

   

6. In the Study Start-up module, select Sites > Site Details page > click the IRB/EC menu in the index panel.
7. The IRB/EC details page is displayed with the General Information section.
8. Click the Change Status button in the General Information section.
9. Select the Conditional Approval status from the list and provide the Comments in the comment box, and click the Save button.