Risk Scoring

Reference:

Release Notes - eTMF

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

This enhancement introduces foundational risk scoring capabilities in eTMF, enabling clinical teams to proactively identify and prioritize high-risk documents and placeholders. With risk scoring, teams gain clear visibility into high-impact areas, allowing for smarter monitoring and earlier interventions.

Administrators can now configure numeric risk values (0–100) for each document type based on regulatory criticality. The system automatically groups scores into High (≥ 80, Red), Medium (40–79, Amber), and Low (< 40, Green) categories. Risk scores are calculated in real time whenever documents or placeholders are created or their document types are updated. These scores are displayed as color-coded indicators and numeric values in key grid views (status, workflow, reviewer, site, country, etc.), allowing users to filter and sort by risk level to focus on the highest-priority records first.

A new Risk Score View provides a dedicated workspace to group documents by risk level, while a dashboard dashlet highlights unfulfilled placeholders by risk category, offering drill-down navigation for immediate action. Site profiles also display a site-level risk roll-up, helping users assess overall site compliance exposure at a glance.

By embedding risk visibility across eTMF, this feature also allows users to perform Quality Reviews and QC workflows based on risk levels. This enables studies to take a risk-based approach to their TMF activities while maintaining consistent quality standards across studies.