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Description

In the SDTMIG, the Exposure (EX) domain is used to represent exposure to study treatment as described in the protocol. The CDASHIG is an interventions domain that contains the details of a subject's exposure to an investigational product. Exposure as Collected (EC) is an interventions domain that contains information about a subject's exposure to an investigational product, as collected. For collection, the EC domain is used to represent data as collected on the CRF, and is used in a study when the SDTMIG tabulation EX domain cannot be directly populated with the data collected on the CRF.

CDASHIG EC is used for collection when:

1. An alias for the actual treatment product name is used (e.g., the study is masked) rather than the actual treatment product name (e.g., the study is open label).
2. Exposure data are collected in non-protocol-specified units (e.g., tablets).
3. Scheduled and/or missed doses exposures are collected.
4. Planned doses (e.g., a calculation based on body weight) are collected in addition to actual doses given.

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