Queries Module

The system shall include a dedicated Queries module that enables users to raise queries against submitted documents when clarification or updated documentation is required. Editors can create and initiate queries, which are communicated to the relevant users through TI notifications and email. The system shall support receiving responses either directly within TI or through email replies. Each query shall be classified under one of the following types: Workflow, Audit, or General.

The SSU and Query modules are enabled for the Room, and a Site is created with Start-Up Specialist and Regulatory Reviewer assigned as Editors. A Regulatory Inspector is added via Site > Security > Regulatory Approvers, and the Site status is set to Pending. The Principal Investigator and Additional Site Contact (both Editor roles) are configured with valid email addresses, and at least one document is available in the Site’s Documents section.