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discontinuationThe act of concluding participation, before completing all protocol-required elements, in a trial by an enrolled subject. Subject discontinuation does not necessarily imply exclusion of the subject’s data from analysis.
Categories of discontinuation
• Dropout—Discontinuation of a trial by a subject or the discontinued subject him- or herself.
• Investigator initiated discontinuation (e.g., for cause).
• Loss to follow-up—Cessation of participation without notice or action by the subject.
• Sponsor initiated.