Study Subject Discontinuation

**Semantic type:** Qualitative Concept

**Definition:** The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a trial. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination of subject" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A]

**Synonyms:** - Clinical Trial Participant Discontinuation - Study Discontinuation - discontinuation - discontinue (participant)