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Studies may be performed under controlled circumstances in clinics.  In these studies, subject may use the study tobacco product of interest ad-librium, or as specified in the protocol.  

In tobacco studies, the use of the subject's normal nicotine product usage (e.g., usually brand of cigarettes, nicotine replacement patches) may be allowed, or discouraged in studies. These products are not supplied by the sponsor, 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.       

Data on the study product of interest are reported in the Exposure as Collected (EC) , and the Exposure (EX) domains as well as the Product Accountability Domain (DA). The DA domain represents details on  on amount of study product dispensed and returned.  

The Exposure as collected (EC) domain is typically used to reflect amounts at the product-level (e.g., number or cigarettes, number of cartridges, number of patches etc and not the actual exposure to the product. The actual exposure to the product would then be represented in EX. The EX data  data exposure is derived from EC,  Product Accountability Domain (DA) and the protocol-specific details on the study product used.    

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.  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, thee these are estimates, they are typically not reported in EX.     

Some sponsor Sponsor may 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.  For example, the derivation for EX may just be the unmasking of the product, and a sponsor may decide not to show the EC because the derivations used for EX are obvious.  

The EX domain is required for all studies that include protocol-specified study treatment. Exposure records may be directly or indirectly determined; metadata should describe how the records were derived. Common methods for determining exposure (from most direct to least direct) include the following:

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