Risk-Based Quality Management with critical data identification and tolerance limits.
The RBQM Plan module implements a structured Risk-Based Quality Management approach with critical data and process identification, risk scoring, tolerance limits, and monitoring strategy definition. It aligns with ICH E6(R2) addendum and FDA/EMA RBQM guidance, providing the foundation for risk-based monitoring activities.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Identify critical data elements and processes that impact subject safety, data integrity, and study outcomes.
| Critical Data | Process | Risk Score | Tolerance | KRI |
|---|---|---|---|---|
| Primary Endpoint (OS) | Efficacy Assessment | High (12) | ±5% | Mortality Rate |
| Adverse Events | Safety Reporting | High (14) | 0 missed SAEs | SAE Reporting Rate |
| Informed Consent | Subject Enrollment | Critical (15) | 100% compliance | Consent Completion |
| Randomization | Treatment Assignment | Critical (15) | 0 errors | Randomization Error Rate |
| Drug Accountability | Investigational Product | Medium (8) | ±2% | IP Discrepancy Rate |
Define quality tolerance levels with upper and lower bounds that trigger investigation and action.
Monitor Key Risk Indicators in real-time with threshold alerts and trend analysis.
KRIs Tracked
12
across 5 risk domains
Within Limits
9
75% green
Approaching Limit
2
Action recommended
Breached
1
Investigation triggered
How RBQM Plan integrates with other CTMS modules in the platform.
RBQM strategy drives monitoring plan
KRIs trigger central monitoring alerts
Risk register feeds RBQM planning
RBQM plan defined per study protocol
AI monitors KRIs and recommends actions