The Trial Design model defines a standard structure for representing the planned sequence of activities and plan for the trial. This includes ways to represent:
- Planned arms (Section 5.1.1, Trial Arms and Trial Elements)
- Planned groups of subjects (Section 5.1.2, Trial Sets)
- Planned sequences of reproductive stages (animal developmental and reproductive toxicology studies; Section 5.1.3, Trial Repro Stages and Trial Repro Paths)
- Planned schedules for activities and data collection (Section 5.1.4, Trial Planned Data Collection)
- Study eligibility criteria (Section 5.1.5, Trial Inclusion/Exclusion Criteria)
- Other aspects of a study, expressed as a series of parameters (Section 5.1.6, Trial Summary Information)
- Characteristics of a study challenge agent (Section 5.1.7, Challenge Agent Characterization)
Many Trial Design domains define study-specific terminology (e.g., for study arms, visits, eligibility criteria), and variables and variable values from these domains are used in subject-level domains.
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