Page History
...
- Derived from actual observation of the administration of drug by the investigator
- Derived from 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 treatment doses cannot yet be reflected in the protocol-specified unit due to blinding requirements, then the EX domain is not expected to be populated.
In the following example, the sponsor reported protocol described usage of a nicotine inhaler uisng the EX and EC domains. Usage of non-protocol defined product usage (alcohol and other tobacco products) 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.
| Example | ||||||
|---|---|---|---|---|---|---|
|
In this example, the EC domiain is not used by the sposnor to represent exposure. Expoure was represented based on the volume of the e-nicotine liquid cartridges.
| Example | ||||||
|---|---|---|---|---|---|---|
|
In this example, both the EC and EX domains are used. Exposure was bsed on the weight of the e-nicotine liquid cartridges.
| Example | ||||||
|---|---|---|---|---|---|---|
|
In this example, subjects were exposed to many study products. The actual dates and times of use for each product is represented.
| Example | ||||||
|---|---|---|---|---|---|---|
|
Overview
Content Tools