Part of Curriculum level 3 - guidance
Module 3.3 - Developing and maintaining safety documentation
This module addresses the deliverables of the clinical risk management process — the clinical risk management plan (CRMP), hazard log, clinical safety case report (CSCR), and safety incident management log — and how they are produced, maintained and kept fit for purpose.
This module will provide:
- Purpose and content of the CRMP, hazard log, CSCR and safety incident management log
- Produces and maintains CRM artefacts
- Assesses whether artefacts are complete and fit for purpose
- Values traceability and auditability
- Keeps artefacts live and current
Learning outcome 3
Demonstrates understanding of key CRM deliverables and their purpose.
Content guidance
1. The four core artefacts
CRMP — purpose, mandatory content, ownership and approval.
Hazard log — structure, content, traceability.
CSCR — assurance argument and supporting evidence.
Safety incident management log — recording and learning from incidents.
2. Keeping artefacts as living documents
Version control, review triggers and configuration management.
Linking hazards to controls to test evidence.
Last edited: 15 July 2026 2:48 pm