Add to Required Documents

To add documents as Required Documents, follow the steps below.

1. Select a document type by expanding the category folders and associated sub-folders.
2. Click on the Add to Required Documents button from the top menu bar.
   
   
   
3. On the Required Documents window, select General or Specific IRB/EC options from the Required For dropdown.
   
   
   
4. If Specific IRB/EC option is selected, specify whether Central or Local IRB.
5. Mandatory specify whether the document type is required for Site Activation or eTMF by clicking on the checkboxes.
6. Click on the Add button once necessary details are configured.
   
   
   

Change Log

To view the change log history, follow the steps below.

1. Select a document type by expanding the category folders and associated sub-folders.
2. Click on the Change Log button from the top menu bar.
3. On the Change Log History window, view the changes made to the document type.