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Study Start-Up
The Start-up module is available to users who have the Study Start-up action selected in the user profile, who are members of the data room’s Study Start-up Team group, and who are Start-up Specialists in the data room.
The Study Start-Up Process in Trial Interactive
The Study Start-Up Module
Regulatory Review
Current View

Current View

The Current View Dropdown offers five views:

By Regulatory Approval Status: The By Regulatory Approval Status groups all the documents as per their review status, i.e., Approved, Rejected, and Pending. Clicking a review status group from the left panel will display the documents belonging to the particular review status group in the grid pane.

By Site: The By Site option groups all the sites based on the review status of its documents. The review statuses of the documents could be Pending, Rejected, and Approved. Clicking a site under a particular review status will display the documents with that review status in the site in the grid pane. Refer to the screenshot below:

By Country: The By Country option lists out the countries to which documents are added. Clicking a country from the left pane will display the documents submitted to the country along with their review status in the grid pane.

By IRB/EC: The By IRB/EC option lists out the IRB/ECs to which documents have been added. Clicking an IRB/EC from the left pane will display the documents submitted to the institution along with their review status in the grid pane. Refer to the screenshot below:

By Document Type: The By Document Type option lists the various document types available to the study start-up. Clicking a document type will display the documents submitted under that type, along with their review statuses, in the grid pane. Refer to the screenshot below: