Steps to Site Activation

A site can be activated once all essential documents are submitted, approved, and the Essential Documents Progress Bar reaches 100%. Only Site Activation Members can activate the site, triggering automatic naming, routing, and filing of documents in the finalized eTMF. Administrators can configure these automation settings in Study Start-Up. The Activate/Reject button appears on the Site Profile Dashboard upon final approval by the Start-Up Specialist and Regulatory Reviewer.

To activate a site in the Trial Interactive Study Start-Up module, a series of steps must be followed.

1. Select a site that displays the Pending status. This opens the Site Details page.
2. Click the Activate Site button displayed on the left side below the Country name. This opens the Activate Site popup window.
3. Select the Site Activation Date by clicking the Calendar icon.
4. Select the appropriate required radio button for the documents to publish to eTMF.
5. Enter the details in all the fields marked with an asterisk * in the right-side panel – Site Activation Fields.
6. Click the Next button.
7. Review and confirm the details in the popup window and click the Activate Site button.

   

Note: The site information and users specific to the SSU site can be imported by TI if the information is provided in a formatted Excel. In addition, sites and users can be added to the site grid.