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Mini protocol sketch continued: Subject 001 is randomized to Drug A and completes treatment. Subject 002 signs consent but drops out before randomization. You are building the planned design first, then later checking actual subject data against it. Which distinction should be clear?

Trial Design describes planned paths; subject-level datasets such as DM/SE/SV describe actual assignment and experience.

Trial Design replaces DM and SE.

Only subjects who completed all visits appear in Trial Design.

Trial Design is populated one record per subject.