Page History

Tobacco products come in a variety of forms that are used in different ways. In addition to leaf tobacco products, they are available as skin patches, chewing gum, nasal and oral sprays, inhalers, lozenges and tablets, and electronic nicotine delivery systems (ENDS).  

ENDS products use an “e-liquid” that usually contains nicotine derived from tobacco, as well as flavorings, propylene glycol, vegetable glycerin, and other ingredients. The liquid is heated to create an aerosol that the user inhales.

Studies evaluate the protocol-specified study product exposure. These study products are typically supplied by the sponsorapplicant. However, sponsor 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 a 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 Substance Use (SU ( ; for cigarettes) and Concomitant Medications (CM (; for nicotine replacements replacement patches) domains.     

Studies may be performed under controlled circumstances in clinics, to ensure that the only nicotine exposure is the study 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) domain.

• The Product Accountability (DA ) domain is based on the Findings General Observation class. This a Findings domain represents for representing the accountability of study products (e.g., such as information on the receipt, dispensing, return, and packaging).
• The Exposure as Collected (EC ) domain is based on the Interventions General Observation class, This domain represents an Interventions domain for representing information about protocol-specified studyproduct study product administrations, as collected. 
• The Exposure ( EX ) domain is based on the Interventions General Observation class. This domain represents an Interventions domain for representing 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 , which would be represented in EX. The EX data exposure is are derived from EC, Product Accountability Domain ( DA) , and the protocol-specific details on the study product.    

The domains needed to represent the exposure in a tobacco product study is are 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 sponsor-applicant 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, ; because 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 situationsituations, 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.  

The EX domain is required for all studies that include protocol-specified study product exposure. 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:

• Derived from actual observation of the administration of  study product by the investigator
• Derived from an automated dispensing device that records administrations
• Derived from subject recall
• Derived from product accountability data
• Derived from the protocol. When a study is still masked and protocol-specified study product exposure cannot yet be reflected in the protocol-specified unit due to blinding requirements, then the EX domain is not expected to be populated.