Exposure

In the SDTMIG, the Exposure (EX) domain is used to represent exposure to study treatment as described in the protocol. The CDASHIG EC domain is used to represent data as collected on the CRF, and is used in a study when the SDTMIG EX domain cannot be directly populated with the data collected on the CRF.

CDASHIG EC is used when:

1. An alias for the actual treatment name is used (e.g., the study is masked) rather than the actual treatment 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 are collected.
4. Planned doses (e.g., a calculation based on body weight) are collected in addition to actual doses given.

A sponsor 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.