Core Information Standard: Reports

15 Appendix A – Risk Matrix (page 44 of 18) in Clinical Safety Case Report (chapter 3 of 5) within Core Information Standard: Reports

Likelihood	Very High	3	4	4	5	5
	High	2	3	3	4	5
	Medium	2	2	3	3	4
	Low	1	2	2	3	4
	Very low	1	1	2	2	3
		Minor	Significant	Considerable	Major	Catastrophic
Consequence

Likelihood Category	Interpretation
Very high	Certain or almost certain; highly likely to occur
High	Not certain but very possible; reasonably expected to occur in the majority of cases
Medium	Possible
Low	Could occur but in the great majority of occasions will not
Very low	Negligible or nearly negligible possibility of occurring

Consequence Category	Interpretation
Consequence Category	Consequence	Patients Affected
Catastrophic	Death	Multiple
Catastrophic	Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term	Multiple
Major	Death	Single
	Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term	Single
	Severe injury or severe incapacity from which recovery is expected in the short term	Multiple
	Severe psychological trauma	Multiple
Considerable	Severe injury or severe incapacity from which recovery is expected in the short term	Single
	Severe psychological trauma	Single
	Minor injury or injuries from which recovery is not expected in the short term.	Multiple
	Significant psychological trauma	Multiple
Significant	Minor injury or injuries from which recovery is not expected in the short term	Single
	Significant psychological trauma	Single
	Minor injury from which recovery is expected in the short term	Multiple
	Minor psychological upset; inconvenience	Multiple
Minor	Minor injury from which recovery is expected in the short term; minor psychological upset; inconvenience; any negligible consequence	Single

	Risk Acceptability
5	Unacceptable level of risk. Mandatory elimination or control to reduce risk to an acceptable level.
4	Unacceptable level of risk. Mandatory elimination or control to reduce risk to an acceptable level
3	Undesirable level of risk. Attempts should be made to eliminate or control to reduce risk to an acceptable level. Shall only be acceptable when further risk reduction is impractical.
2	Tolerable where cost of further reduction outweighs benefits gained.
1	Acceptable, no further action required

Page last updated: 28 July 2026