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Part of Curriculum level 3 - guidance

Module 3.3 - Developing and maintaining safety documentation

Current Chapter

Current chapter – 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:

Knowledge
  • Purpose and content of the CRMP, hazard log, CSCR and safety incident management log
Skills
  • Produces and maintains CRM artefacts
  • Assesses whether artefacts are complete and fit for purpose
Behaviours
  • 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