Parent class: Protocol-concept
Subclasses:
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