Page History
Description/Overview
The EM domain is an Events domain used to collect information on malfunctions and events that may occur in the use or testing of a tobacco product device. These events may include malfunctions, calibrations, or parts replacement. It is an optional domain, to be used only if the applicant has events/issues with the tobacco product device that should be reported. Records are specific to an individual tobacco product device. The entries may be related to 1 or many subjects, depending upon the type of tobacco product device and scope of its use. Applicants will ensure that appropriate regulatory guidelines for reporting tobacco product device events are followed. If a coding dictionary is used, NSVs may need to be added to represent the various coding level variables defined in the dictionary. Event terms may be captured either as free text or via a prespecified list of terms.
If a malfunction or other product event results in a subject adverse experience, then that information should be recorded in the AE domain.
Specification
| Expand | ||||||
|---|---|---|---|---|---|---|
| ||||||
|
Assumptions
| Include Page | ||||
|---|---|---|---|---|
|
| Pagenav |
|---|
Overview
Content Tools