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  1. If the SDTMIG tabulation EC dataset would be an exact duplicate of the SDTMIG tabulation EX dataset, then the sponsor applicant may choose to collect data using either the CDASHIG collection EC or EX domain. (See the SDTMIG for additional information on submission.)
  2. The collected --TRT value is the name of the study treatment that is known to the subject or investigative site (e.g., ECTRT="TABLET A" when EXTRT=<treatment name>). 
  3. . 
  4. If an exposure

    If dosing data are collected in non-protocol-specified units, the data are collected in CDASHIG EC dataset, then programmatically converted to the protocol-specified units when the data are mapped to the SDTMIG EX domain. 

    Dosing units specified in the protocol

    Dosing information as collected
    on the CRF and represented in EC

    Representation in EX

    200 mg tablet

    2 tablets

    400 mg

    100 mg capsule

    1 capsule

    100 mg

    5 mg/kg

    99 mL

    5 mg/kg

    If a treatment is such that start and stop times are not required, and only 1 dosing exposure date is collected, then the collected dosing date collected exposure date will map to both the start date date (--STDTC) and end date date (--ENDTC) in the submitted tabulation exposure dataset(s).
  5. If scheduled dosing is collected, the ECMOOD variable may be used to distinguish between "SCHEDULED" and "PERFORMED" dosing records. The sponsor may choose to use this variable to capture multiple scheduled dosing records, if needed.
  6. ECOCCUR:
    1. ECOCCUR value of "N" indicates a dose was not taken, not given, or missed. 
    2. ECOCCUR is generally not applicable for Scheduled records. 
    3. ECOCCUR = "N" is the standard representation of the collected doses not taken, not given, or missed.
  7. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not taken, not given, or missed.