Part of Curriculum level 3 - guidance
Module 3.1 - Roles and responsibility of a CSO
This module sets out the statutory role of the Clinical Safety Officer (CSO), accountabilities across the system lifecycle, and the boundaries of CSO oversight. Participants will be able to articulate the CSO role and identify when approval and oversight is required.
This module will provide:
- Statutory role of the Clinical Safety Officer under DCB 0129 and DCB 0160
- Accountability of the CSO across the system lifecycle
- Relationship between manufacturer, supplier, deployer and commissioner roles
- Eligibility to become a CSO as per DCB standards
- Explains the CSO responsibilities and activities to clinical and technical colleagues
- Identifies when CSO oversight is required
- Takes ownership of clinical safety
- Escalates concerns appropriately
- Maintains professional independence
Learning outcome 1
Demonstrates understanding of the role and responsibilities of the CSO.
Content guidance
1. Statutory basis and scope of the CSO role
The CSO role under DCB 0129 and DCB 0160.
Manufacturer CSO versus deployer CSO — scope and duties.
Limits of CSO authority and where escalation is required.
2. Accountabilities across the lifecycle
Concept, design, build, deploy, operate and decommission.
Sign-off points and the CSCR as the CSO's primary accountability artefact.
Independence and conflicts of interest.
3. Relationships across the supply and deployment chain
Manufacturer, supplier, deployer, commissioner — definitions and interfaces.
Escalation routes within and beyond the host organisation.
Last edited: 16 July 2026 9:45 am