Parent class: Protocol
Subclasses:
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 ClinicalTrials.gov" | 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 ClinicalTrials.gov" | 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 ClinicalTrials.gov" | 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