Clinical Safety Case Report
and hazard log support.
Dr Chiho Song prepares the DCB 0129 safety evidence NHS digital health suppliers are asked for: Clinical Safety Case Report, hazard log, Clinical Risk Management File, safety requirements and signed CSO release memo.
If someone has asked for your safety case.
A request for a “clinical safety case”, “hazard log”, “CSCR” or “CRMF” usually means the buyer is asking for DCB 0129 evidence. It is not just a document title. The report has to trace back to real hazard analysis, controls, verification and a Clinical Safety Officer’s residual-risk judgement.
This page is the deliverable-level route. For the wider package, see DCB 0129 / DCB 0160 compliance; for budget planning, see Clinical Safety Officer cost. If the request came through DTAC, see DTAC clinical safety evidence.
What I produce.
The documents are designed to work together. A CSCR without a credible hazard log behind it will not survive serious review.
Clinical Risk Management Plan
Scope, lifecycle, roles, risk acceptance criteria, review cadence and the method used for clinical risk analysis.
Hazard log
Structured hazards, causes, clinical harms, controls, owners, verification evidence, initial risk and residual risk.
Clinical Risk Management File
A traceable file containing the plan, hazard log, safety requirements, evidence, change records and release notes.
Clinical Safety Case Report
The readable argument that the defined product and release are acceptably safe in the intended context.
Safety requirements
Controls translated into engineering-actionable requirements and mapped back to hazards and verification evidence.
Signed CSO release memo
The accountable Clinical Safety Officer statement that residual clinical risk is acceptable for the defined release.
What makes the evidence credible.
Send what you have.
If you already have a draft CSCR, hazard log or CRMF, send the current state and the context. I will tell you whether it needs repair, a fresh safety case, or only evidence mapping for DTAC or a trust review.
What has been requested?
Why these documents matter.
NHS clinical safety assurance uses the hazard log and clinical safety case to show that clinical risks from health IT have been identified, controlled and reviewed by a Clinical Safety Officer.
DCB 0129 explained
How the clinical safety standard works and where these documents fit.
Read → DTACClinical safety evidence
How the same documents support the clinical safety section of NHS DTAC.
Read → NHS EnglandDigital clinical safety assurance
Primary-source context on the hazard log and clinical safety case.
Open source →