- EM captures information about a variety of activities (e.g., malfunctions, calibrations, parts replacement) that can occur to or with tobacco product devices. It is an optional domain, to be used only if the applicant has events that should be reported or that they otherwise want to track. Records are specific to an individual device (SPTOBID). The entries may or may not be related to a study subject. EM is not to be used for non-tobacco-product device events.
- Events represented in the EM domain will be consistent with scientific and regulatory requirements. It is the applicant's responsibility to define an event and the appropriate collection period for events. This definition may vary based on product characterization and reporting of product safety. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection.
- USUBJID is Permissible in this domain, but should only be populated if the device event is associated with a subject's use of the product. See the CDISC Notes column in the specification for further explanation.
- If a malfunction or other event results in an adverse experience for a subject, then that information should be recorded in the AE domain. See Section 2.8.10.1, Adverse Events (AE) for more information on how to represent subject adverse experiences. See also Section 2.8.5.2, Relating Subject Records and Datasets for more information on how to relate the records between EM and AE. TOBA-557 - Getting issue details... STATUS TOBA-558 - Getting issue details... STATUS
- EMSTDTC is the date/time of the device event. EMENDTC (end date/time) TOBA-99 - Getting issue details... STATUS can be used, for example, if a malfunction occurs during a deployment and it is repaired later.
- If this domain is used to capture device malfunctions and a controlled terminology coding dictionary is used to code the event, then any codes beyond the value shown in EMDECOD can be included as non-standard variables.
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