Risk register with mitigation tracking and issue resolution workflows.
The Risk & Issue Management module maintains a comprehensive risk register with probability-impact scoring, mitigation plans, and residual risk assessment. Issues are tracked through structured resolution workflows with assignment, root cause analysis, CAPA linkage, and closure verification.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Maintain a structured risk register with probability-impact scoring. Visual heat map identifies high-priority risks.
| Risk ID | Description | Probability | Impact | Score | Status |
|---|---|---|---|---|---|
| R-001 | Slow enrollment at EU sites | High | Medium | 12 | Mitigating |
| R-002 | Protocol amendment delay | Medium | High | 12 | Monitoring |
| R-003 | CRO resource constraints | Medium | Medium | 9 | Accepted |
| R-004 | Data quality at Site D | Low | High | 8 | Mitigating |
| R-005 | Regulatory query response | Low | Medium | 6 | Closed |
Track issues through structured resolution workflow from identification to closure with root cause analysis.
ISS-001
Protocol deviation at Site B
ISS-002
Data entry backlog at Site D
ISS-003
Missed visit — Subject 012
ISS-004
Lab sample shipping delay
ISS-005
CRF completion error
Overview of risk profile across the study with trend analysis and mitigation progress tracking.
Total Risks
24
12 active, 12 closed
High Priority
4
Requires action
Open Issues
7
3 escalated
CAPA Linked
3
Quality integration
How Risk & Issue Management integrates with other CTMS modules in the platform.
Quality issues linked to CAPA workflows
Risks trigger targeted monitoring activities
Risk register feeds RBQM strategy
Study-level risk profile maintained
AI analyzes risk patterns for recommendations