Parent class: Protocol-concept


Documentation: "Description of the objective(s), design, methodology, statistical analysis, and organization of an additional investigation pertaining the same interventions as the primary trial."

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
exclusion-rules   Instance Exclusion-rule    
secondary-outcomes   Instance Secondary-outcome    
entrance-criteria-comment "General comments on the application or other aspects of subject selection." STRING   0:1  
secondary-study-groups "Study groups of secondary studies must be subgroups of the original study groups of the main trial." Instance Subgroup-population    
stopping-rule "Description of the stopping rule used, if any." Instance Stopping-rule 0:1  
subgroups "Pointers to both a priori and post-hoc subgroup definitions and thence to the actual subgroup populations." Instance Subgroup    
secondary-recruitment-flowchart   Instance Recruitment-flowchart 0:1  
ancillary-outcomes   Instance Ancillary-outcome    
age-gender-entrance-criteria   Instance Age-gender-rule 0:1  
efficacy-analysis? "Whether analyses were performed on the basis of actual intervention received, rather than intervention assigned. A study may have both efficacy and intention-to-treat analyses." SYMBOL Yes No Not specified 0:1  
baseline-characteristics "The clinical characteristics of this population at baseline. Modeled as comparisons of individual datapoints among populations." Instance Baseline    
intention-to-treat-analysis? "Whether analyses were performed on basis of participant's assigned intervention. A study may include both intention-to-treat and efficacy analyses." SYMBOL Yes No 0:1  
side-effects "Clinical outcomes that are side effects. Details of assessment, statistical analysis, and results are at the object pointed to." Instance Side-effect    
ethnicity-language-entrance-criteria   Instance Ethnicity-language-rule 0:1  
follow-up   Instance Follow-up 0:1  
hypotheses "These cannot be primary hypotheses since that is the main hypothesis of the main trial. These are all technically secondary hypotheses." Instance Secondary-hypothesis    
recruitment   Instance Recruitment 0:1  
primary-outcomes   Instance Primary-outcome    
crossover-groups "Points to the groups of subjects that crossed from one to another arm." Instance Crossover-population    
study-monitoring "Description of how the study as a whole was monitored. Specific details of data monitoring are described in the relevant STUDY-COMMITTEEs." Instance Study-monitoring 0:1  
inclusion-rules   Instance Inclusion-rule    
blinding-efficacy "Details about intervention binding , including blinding efficacy, of investigators, subjects, nurses, etc." Instance Blinding-efficacy 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