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Description
Exposure (EX) 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 tabulation EX domain cannot be directly populated with the data collected on the CRF.
EC is used for collection when:
- An alias for the actual product name is used rather than the actual product name.
- Exposure data are collected in non-protocol-specified units.
- Scheduled and/or missed exposures are collected.
- Planned exposures are collected in addition to actual exposures.
An applicant may choose to always collect exposure data using the EC domain.
Specifications
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Exposure (EX)
Exposure as Collected (EC)
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Assumptions
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Overview
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