In many medical domains investigatorinitiated
clinical trials are used to introduce new treatments
and hence act as implementations of guidelinebased
therapies. Trial protocols contain detailed instructions
to conduct the therapy and additionally specify
reactions to exceptional situations (for instance an
infection or a toxicity). To increase quality in health
care and raise the number of patients treated according
to trial protocols, a consultation system is needed that
supports the handling of the complex trial therapy processes
efficiently. Our objective was to design and
evaluate a consultation system that should 1) observe
the status of the therapies currently being applied,
2) offer automatic recognition of exceptional situations
and appropriate decision support and 3) provide an
automatic adaptation of affected therapy processes
to handle exceptional situations.