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Description/Overview
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Exposure (EX)
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is an Interventions domain used for the details of a subject's exposure to a study product. Exposure as Collected (EC) is an interventions domain used for information about a subject's exposure to a study 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
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tabulation EX domain cannot be directly populated with the data collected on the CRF.
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EC is used for collection when:
- An alias for the actual treatment product name is used (e.g., the study is masked) rather than the actual treatment name (e.g., the study is open label)product name.
- Exposure data are collected in non-protocol-specified units (e.g., tablets).
- Scheduled and/or missed doses exposures are collected.
- Planned doses (e.g., a calculation based on body weight) exposures are collected in addition to actual doses givenexposures.
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An applicant may choose to always collect exposure data using the
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EC domain.
Extensive discussion of the use of the EC and EX domains, including examples of data collection, is available in the SDTMIG.
Specifications
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Exposure (EX)
Exposure as Collected (EC)
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Assumptions
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