All Documents

The view presented to users in the All Documents tab for each site, country, and IRB/EC shows both the Essential Documents and the non-Essential Documents associated with the site, country or IRB/ EC selected.

The All Documents tab for each of the modules consists of a menu bar which allows various functionalities. Refer to the screenshot below:

The functionalities of this menu bar are the same as in the Documents section of the SSU and can be referred there.

Review of Non Essential Documents

If the Study Start-Up Settings specify that the documents will need to be approved through the ‘Two pass workflow in Study Start-Up’ the documents automatically acquire the Pending status under QC Review. The documents will then have to be approved under QC Review and submitted for Regulatory Review.

The process for reviewing and approving the documents is as follows:

1. From the Grid Pane select the non-essential document to Approve/Reject.

2. From the top menu bar of the grid, click the Approve/Reject button.

3. In the pop up window of Approve/Reject documents, select the status as Approved or Rejected.

4. Once the document is approved, the Submit To Review button is activated; clicking which you can submit the document for QC Review.

5. Click Yes in the Regulatory Review pop up window. Refer to the screenshot below.