Parent class: Design-concept

Subclasses:

Template Slots |
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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 *