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- 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.
The example below illustrate various methods for displaying study product exposure data, as well as data that may be collected on the usage of other nicotine sources.
In the following example, the sponsor reported protocol described usage of a nicotine inhaler using the EX and EC domains. Usage of non-protocol defined product usage (alcohol and other tobacco products) during the study were represented in the SU domain. Additionally, any usage of nicotine patches to reduce dependency on tobacco were reported in the CM domain. Study product exposure was represented as the number of cartridges used. The pharmaceutical strength of each cartridge was represented.
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In this example, the EC domain is not used by the sposnor to represent collected exposure. Expoure was represented based on the volume of the e-nicotine liquid cartridges.
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In this example, both the EC and EX domains are used. Exposure was based on the weight of the e-nicotine liquid cartridges.
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In this example, subjects were exposed to mulitple study products. The actual dates and times of use for each product is represented.
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