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changes.mady.by.user Lou Ann Kramer

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  1. Definition:
    1. The Exposure (EX) domain model records the details of a subject's administered dose of protocol-specified study treatment. "Study treatment" may be any intervention that is prospectively defined as a test material within a study, and is typically, but not always, administered to the subject. Examples include but are not limited to placebo, active comparators, and investigational products. Only protocol-specified treatments should be included in this domain.
    2. This domain should contain 1 record per constant dosing interval per subject per administration site (as identified in FOCID). A constant dosing interval is sponsor-defined and represents a specific period of time during which a subject was treated with a specific lot at a constant dose level. For example, for a study with once-a-week administration of a standard dose for 6 weeks, the administered dose may be represented with a single record per subject, spanning the entire treatment phase. Alternatively, a separate entry can be made for each treatment administration and for any deviations in treatment that occur. For this example, there could be up to 6 records (one for each weekly administration).
    3. Either USUBJID or POOLID must be populated.
  2. Treatment description:
    1. EXTRT captures the name of the administered treatment. Because EXTRT is the topic variable, it is required and must have a value. EXTRT should include only the treatment name and should not include dosage, formulation, or other qualifying information. For example, "ASPIRIN 100 mg TABLET" is not a valid value for EXTRT. This example should be expressed as EXTRT= "ASPIRIN," EXDOSE= "100," EXDOSU= "mg," and EXDOSFRM= "TABLET".
    2. A single control for multiple compounds should contain values separated with a pipe/vertical bar (|).
  3. If a subject is treated sequentially with different lots, then a new record must be created for each lot number given.
  4. EXDOSE: The sponsor's data definition file should indicate whether the values in EXDOSE represent intended or actual dose levels.
  5. Timing variables: The timing of dosing of study treatment is captured by the start/end date and start/end time of each constant-dosing interval. The sponsor defines the dosing interval.
  6. Other additional qualifiers from the SDTM Interventions class may be added to this domain.

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