Part of Curriculum level 3 - guidance
Module 3.7 - The safety case and safety case report
This module develops capability in building, maintaining and reviewing Clinical Safety Cases (CSC) and Clinical Safety Case Reports (CSCR), including supplier and provider test evidence requirements.
This module will provide:
- Purpose of CSC and CSCR and the relationship between them
- Typical CSCR structure and lifecycle evolution
- What 'good' looks like in a CSCR and common weaknesses
- Supplier and provider testing responsibilities
- Authors and updates CSCRs across the lifecycle
- Critically reviews CSCRs and provides constructive feedback
- Evaluates test evidence against stated requirements
- Treats safety cases as living documents
- Constructively challenging, safety-focused
- Evidence-led and objective
Learning outcome 15
CSC and CSCR concepts.
Content guidance
1. Using the safety case as an assurance tool
Purpose of CSC and CSCR and their relationship.
Explaining them to clinical and technical stakeholders.
Iterative use across the lifecycle.
Learning outcome 16
Structure and iterative development of a CSCR.
Content guidance
1. Building and evolving a CSCR
Typical CSCR structure and section purpose.
Version control across releases.
Linking evidence as it accumulates.
Approaches to updating the CSCR.
Updating your CSCR in response to patient safety incident data.
Learning outcome 17
Reviewing and critiquing a CSCR.
Content guidance
1. Reviewing for argument and evidence
What 'good' looks like in a CSCR.
Common weaknesses — gaps, weak arguments, unsupported claims.
Structured feedback for improvement.
Learning outcome 18
Supplier and provider test requirements and evidence
Content guidance
1. Test evidence as part of the assurance argument
Supplier and provider testing responsibilities.
Types of test evidence used to support clinical safety assurance.
Identifying gaps and limitations in evidence.
Last edited: 16 July 2026 10:43 am