Parent class: Design-concept
Subclasses:
Documentation: "A condition that, if met, would cause suspension of enrollment in the trial."
Template Slots | |||||
Slot name | Documentation | Type | Allowed Values/Classes | Cardinality | Default |
when-stopping-rule-defined | "If defined a priori, was defined before subject enrollment or randomization began." | SYMBOL | A Priori Post-hoc | 0:1 | |
stopping-rule-description | "Description of the rule (may be statistical) of when study may be stopped prematurely." | STRING | 0:1 | ||
protocol-changes | Instance | Protocol-change | |||
roles | "Tells which class and slot will take instances of this class depending on the role of the instance. The format is (role OWNER-CLASS |owner-slot|) e.g., if this class is DATE and the instance's role is recruitment-start-date, (recruitment-start-date RECRUITMENT |start-date|) tells us that this instance of date should be the value of the slot |start-date| in an instance of class RECRUITMENT." | SYMBOL | 0:1 |
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Generated on Mon Dec 15 11:40:40 2008