Formalisation of safety reasoning in protocols and hazard regulations.

Written protocols are often employed to guide patient care. For treatment within a clinical trial, compliance with the trial protocol may be critical in ensuring efficacy and safety. Previous empirical work has established generic safety principles for reasoning about adverse events in clinical trials and their formalisation has been applied in a decision support system for managing treatment plans in oncology. The same generic knowledge can be reused to generate specific safety clauses when designing new treatment plans. Typically, clinicians devise trial protocols relatively infrequently and so software aids, especially those assisting with regulatory/safety conformance, will encourage more effective use of their time. A similar approach to the formalisation of safety knowledge in the control of hazardous industrial processes is discussed.