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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 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 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) exposures are collected in addition to actual doses givenexposures.

A sponsor An applicant may choose to always collect exposure data using the CDASHIG 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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