QC Review and Regulatory Approval of Amendments

After the documents for amendment are added, essential documents will need to pass the QC Review and Regulatory Approval.

The non-essential documents will need to pass through the approval process only if it is specified in the Study Start-Up settings. The settings in this section also apply to the amendments.

The process to review and approve the documents for both the processes is the same as described in earlier sections.

To Regulatory Review the documents, the Regulatory Approver will need to log in to the system and enter the Regulatory Review section. Here too, the Regulatory Approver selects the required amendment from the Filter By Amendment dropdown in the Current View panel and selects the documents to Approve/Reject them from the Grid Pane.