eTMF Event Based on CTMS Milestone Status

Reference:

Release Notes - eTMF

• eTMF v10.8 Pre-Release Notes v0.1
• eTMF v10.8 Pre-Release Notes v0.2

This feature introduces interoperability between CTMS milestones and eTMF event triggers, enabling a more automated, activity-driven approach to event creation and placeholder management. Previously, milestone tracking and eTMF event setup were handled separately, requiring manual updates and increasing the risk of misalignment between operational timelines and regulatory documentation. By linking milestone status changes directly to eTMF triggers, this update establishes a seamless cross-system workflow that improves accuracy, consistency, and speed.

Users can configure Event Trigger mappings using a unique combination of Milestone Name and Organizational Level (Study, Country, Site). Standard milestone templates are supported across levels, while study-specific milestones can be mapped manually. Once defined, CTMS sends real-time milestone status updates to eTMF:

• In Progress milestones become available in the TI Event Manager, signaling the start of activities.

• Completed milestones trigger event creation and document placeholder generation in TI.

  Planned and completion dates, classifications, risk levels, and document type references are synchronized to ensure accurate event configuration.

By introducing milestone-driven triggers, this feature eliminates manual placeholder setup, ensures timely alignment between study operations and documentation, and lays the foundation for a unified, cross-application study management experience between CTMS and eTMF.