Health / Medical Topics

    CDISC SDTM Trial Phase Terminology

    Definition 1

    Terminology codelist used with the Trial Phase within the Clinical Data Interchange Standards Consortium Study Data Tabulation Model. (NCI Thesaurus)

    Definition 2

    Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NCI Thesaurus/CDISC)




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