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Studies evaluate the protocol-specified study product exposure. These study products are typically supplied by the sponsorapplicant. However, sponsors applicants often collect exposure to other nicotine sources.      

The subject's normal nicotine product usage (e.g., usually brand of cigarettes, nicotine replacement patches) may be allowed, or discouraged in the study.  These products are not supplied by the sponsorapplicant, and are not considered a study product. The use of these products would be represented in the SU ( for cigarettes and CM (for nicotine replacements patches) domains.     

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The domains needed to represent the exposure in a tobacco product study is decided by the sponsorapplicant. Some sponsors applicants 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 sponsorapplicant-defined and is used to support the study purpose and analysis. EX derivations must be described in the Define-XML document. 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, these are estimates, they are typically not reported in EX.     

Sponsors Applicants may find it easier to report both the collected data in EC and the derived EX data to provide tracking of the summarized exposure to what was collected.

In some situation, sponsors applicants may elect to only use the EX and, if needed, the DA domain. EX would be used when little relevant information is represented in EC (i.e., when EC and EX would essentially be duplicates of each other).  For example, the derivation for EX may just be the unmasking of the product, and a sponsor applicant may decide not to show the EC because the derivations used for EX are obvious.  

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