Parent class: Design-concept


Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
justification-for-one-tailed-test "If the statistical test is one-tailed, it's use must be explained." STRING   0:1  
margin-of-equivalence "The margin of equivalence defined for an equivalence or non-inferiority trial." STRING   0:1  
alpha-tails "also called 'sides'" SYMBOL One-tailed Two-tailed 0:1  
threshold-rate-rationale   STRING   0:1  
upper-ci   FLOAT   0:1  
estimated-icc "Estimated intracluster correlation coefficient" FLOAT   0:1  
threshold-exp-group-outcome   STRING   0:1  
sample-size-calculation-method   STRING   0:1  
comments   STRING   0:1  
lower-ci   FLOAT   0:1  
confidence-interval-percent   SYMBOL 90% c.i. 95% c.i. 99% c.i. 0:1  
assumptions-underlying-target-enrollment "Describe assumptions that impact on target enrollment versus sample size. e.g., assumptions on proportion of eligible subjects who will agree, number who will stay in study, etc." STRING   0:1  
alpha-value "Acceptable probaliity of a false positive for rejecting the null hypothesis. Often 0.05." FLOAT   0:1  
power "1-the probability of a false negative. Is 1-beta, is a real number between 0 and 1, often 0.80." FLOAT   0:1  
base-rate-rationale   STRING   0:1  
baseline-comparison-group-outcome   STRING   0:1  
target-sample-size   INTEGER   0:1  
referent-outcome "The outcome on which the sample size requirements for this study were calculated." Instance Primary-outcome 0:1  
estimated-min-cluster-size "Estimated minimum cluster size" INTEGER   0:1  
target-enrollment   INTEGER   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