Page History

...

The domains needed to represent the exposure in a tobacco product study is decided by the sponsor. Some sponsor use the EC domain to reflect the collected exposure data, and then derive EX. The degree of summarization of records from EC to EX is sponsor-defined and is used to support study purpose and analysis.  More detail summarization may also be performed in ADaM.  For example, the estimated daily nicotine exposure may based on self-reported nicotine exposure may be provided. Since, thee are estimates, they are typically not reported in EX.     

Some sponsor find it easier to report both the collected data in EC  and the derived data EX data to provide tracking of the summarized exposure to what was collected. In many cases, the derivation for EX, may just  be the unblinding of the product, and sponsor decide not to show the EC because the derivation used for EX is obvious. 

In some situation, sponsor may elected to only use the EX, and if needed the DA domain. EX would be used-when little relevant information is represented in EC, in a sense EC and EX are essentially duplicates of each other. 

...