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?:definition
  • The completed activity within the context of a given study that is not directly related to the study\'s overarching hypothesis evaluation or testing, but is nonetheless essential to the efficient and/or effective coordination and execution of the study. EXAMPLE(S): assignment to a treatment arm, registration to a study, start of on-study period, end of on-study period, obtain informed consent, verify eligibility criteria, enroll, randomize, complete study visits, exit trial, break treatment blind, protocol violation, premature withdrawal, etc.
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