- If the SDTMIG EC dataset would be an exact duplicate of the SDTMIG EX dataset, then the sponsor may choose to collect data using either the CDASHIG EC or EX domain. (See the SDTMIG for additional information on submission.)
- 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>).
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 ECRepresentation 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 date is collected, then the collected dosing date will map to both the start date (--STDTC) and end date (--ENDTC) in the submitted exposure dataset(s).
- 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.
- ECOCCUR:
- ECOCCUR value of "N" indicates a dose was not taken, not given, or missed.
- ECOCCUR is generally not applicable for Scheduled records.
- ECOCCUR = "N" is the standard representation of the collected doses not taken, not given, or missed.
- 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.
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