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Studies may be performed under controlled circumstances in clinics, to ensure that the only nicotine exposure is the product itself.     

Exposure data on the study product of interest are reported in the Exposure as Collected (EC) and/or the Exposure (EX) domains as well as the Product Accountability Domain (DA).

• The Product Accountability (DA) is a findings domain

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• that represents the accountability of study products, such as information on the receipt, dispensing, return, and packaging.
• The Exposure as Collected (EC) is an interventions domain that represents information about protocol-specified studyproduct administrations, as collected. 
• The Exposure (EX) is an interventions domain that represents a subject's exposure to protocol-specified study product.  Study product is usually an intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject.

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 exposure is derived from EC, Product Accountability Domain (DA) and the protocol-specific details on the study product.    

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