Query management in SSU

Reference:

Release Notes - SSU

A structured Query Management system within SSU, allowing Start-up Specialists, Regulatory Reviewers, and Sponsors to raise, track, and resolve queries on submitted documents prior to approval. The enhancement addresses the previous absence of a formal clarification process, improving traceability, audit readiness, and overall efficiency in managing document-related inquiries.

Users can now raise queries during their review stages and trigger notifications via TI and email. Queries can be answered either in TI or by replying to the email, with all actions recorded in a complete audit trail. Once resolved, the issuer can close the query, allowing the document to move forward. Documents with open queries cannot be approved, ensuring all issues are addressed beforehand. Query history is retained when documents move to eTMF.

All queries follow a Pending → In-Progress → Resolved lifecycle and appear in the dedicated Query Module that displays both open and closed items. Start-up Specialists and Regulatory Reviewers can assign queries to Site Contacts, CRAs, Document Submitters, or other roles to ensure targeted follow-up.

By embedding structured query handling into SSU, this feature streamlines communication, enforces review controls, and strengthens audit readiness.