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As illustrated in the study schema diagram for Example Trial 1, this simple parallel trial has 3 arms, corresponding to the 3 possible left-to-right "paths" through the trial. Each path corresponds to 1 of the 3 treatment elements at the right end of the diagram. Randomization is represented by the 3 red arrows leading from the Run-in block.

   


Excerpt Include
SDTMIG:Example Trial 1, Parallel Design Study Schema
SDTMIG:Example Trial 1, Parallel Design Study Schema

The next diagram for this trial shows the 3 epochs of the trial, indicates the 3 arms, and shows the sequence of elements for each group of subjects in each epoch. The arrows are at the right side of the diagram because it is at the end of the trial that all the separate paths through the trial can be seen. Note that, in this diagram, randomization—which was shown using 3 red arrows connecting the Run-in block with the 3 treatment blocks in the first diagram—is indicated by a note with an arrow pointing to the line between 2 epochs.

Excerpt Include
SDTMIG:Example Trial 1, Parallel Design Prospective View
SDTMIG:Example Trial 1, Parallel Design Prospective View

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