Parent class: Protocol


Documentation: "Eligibility rules, outcomes, treatment assignment and other protocol details applied to the individual participants in a cluster-randomized trial."

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
general-compliance-results-comment   STRING   0:1  
adverse-events-comment "General comments on adverse events and/or their results." STRING   0:1  
recruitment-flowchart   Instance Primary-recruitment-flowchart 0:1  
baseline-characteristics-comment   STRING   0:1  
exclusion-rules   Instance Exclusion-rule    
secondary-outcomes   Instance Secondary-outcome    
study-classification "The phase of the trial. The value list is from" SYMBOL N/A Safety Efficacy Safety/Efficacy Bio-equivalence Bio-availability Pharmacokinetics Pharmacodynamics Pharmacokinetics/Pharmacodynamics 0:1  
entrance-criteria-comment "General comments on the application or other aspects of subject selection." STRING   0:1  
comparison-arm   Instance Comparison-arm 0:1  
treatment-assignment   Instance Treatment-assignment 0:1  
secondary-hypotheses "Hypotheses of the study that were not used to calculate sample size." Instance Secondary-hypothesis    
individual-level-protocol "Pointer to the protocol for the individual participants in a cluster-randomized trial." Instance Cluster-individual-protocol 0:1  
subgroups "Pointers to both a priori and post-hoc subgroup definitions and thence to the actual subgroup populations." Instance Subgroup    
study-phase "The phase of the trial. The value list is from" SYMBOL N/A Phase 0 Phase 1 Phase 1/Phase 2 Phase 2 Phase 2/Phase 3 Phase 3 Phase 4 0:1  
ancillary-outcomes   Instance Ancillary-outcome    
primary-purpose "The primary purpose of the trial. The value list is from" SYMBOL Treatment Prevention Diagnostic Supportive Care Screening Health Services Research Basic Science Other 0:1  
age-gender-entrance-criteria   Instance Age-gender-rule 0:1  
baseline-characteristics "The clinical characteristics of this population at baseline. Modeled as comparisons of individual datapoints among populations." Instance Baseline    
study-groups   Instance Study-arm-population    
cointerventions   Instance Cointervention    
general-stats-method "General comments on statistical methods used, e.g., that continuous variables were tested using t-tests." STRING   0:1  
sample-size-calculation   Instance Sample-size-calculation 0:1  
intervention-completion-comment   STRING   0:1  
blinding-methods "Methods used to blind providers, subjects, study nurses, investigators to the subject's assigned intervention." Instance Blinding-methods 0:1  
side-effects-comment "General comments on side effects and/or their results." STRING   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    
primary-hypothesis "The primary hypothesis of this study. As rigorously defined, should only refer to the primary outcome, and be the statistical context for calculating this study's sample size." Instance Primary-hypothesis 0:1  
ethnicity-language-entrance-criteria   Instance Ethnicity-language-rule 0:1  
follow-up   Instance Follow-up 0:1  
trial-design   Instance Trial-design 0:1  
recruitment   Instance Recruitment 0:1  
exclusive-eligibility-exclusion? "Whether subjects excluded from eligiblity are counted as meeting only a single exclusion criterion or more than one if applicable." SYMBOL Exclusive exclusion Not exclusive exclusion 0:1  
study-sites   Instance Study-site 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  
experimental-arms   Instance Experimental-arm 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