Represents each planned arm in the trial study including the sequences of elements in each epoch for each arm. The TA and TE datasets are interrelated and provide the building blocks for subject-level information.
Nonclinical
Product Impact on Individual Health
2
Trial Elements (TE)
Represents the elements used in the trial study including unique codes for each element, element descriptions, and the rules for starting and ending an element. The TA and TE datasets are interrelated and provide the building blocks for subject-level information.
Nonclinical
Product Impact on Individual Health
3
Trial Visits (TV)
Represents the planned order and number of visits in the trial study within each arm
Product Impact on Individual Health
4
Trial Inclusion/Exclusion (TI)
Represents the inclusion and exclusion criteria for the trialstudy
Product Impact on Individual Health
5
Trial Summary (TS)
Represents key summary characteristics for the trialstudy
Nonclinical
Product Impact on Individual Health
6
Trial Sets (TX)
Represents planned sets of subjects that result from combinations of experimental factors defined for the trial study