" /> Completed Clinical Study - CISMeF





Preferred Label : Completed Clinical Study;

NCIt synonyms : Completed Study; Study Completed Status; Completed; Study Completed; Clinical Study Completed;

NCIt related terms : study completion;

NCIt definition : A clinical study that has been completed, with all protocol objectives met. Subjects are no longer being examined or treated. Final data for the primary and secondary outcome measures, and adverse events, have been collected and the database for the study has been locked. All essential documents and the closure letter from the Principal Investigator/Study Director have been provided.;

Alternative definition : CDISC-GLOSS: As defined in the protocol, the point at which all protocol-required activities have been executed. NOTE: According to EU CTR, this should be a clear and unambiguous definition of the end of the clinical trial in question and, if it is not the date of the last visit of the last subject, a specification of the estimated end date and a justification thereof should be included. [REGULATION (EU) No 536/2014 Article 2.26];

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Keyword's position in hierarchy(ies) : arborescence

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01/08/2025


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