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- PI EM captures information about a variety of activities that can occur to or with tobacco product devices (e.g., malfunctions, calibrations, or parts replacement). It is an optional domain, to be used only if the sponsor 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.
- USUBJID is Permissible in this domain, but should be populated if the device event is associated with a subject. See CDISC Notes 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 AE domain specification and assumptions for more information). The relationship between the AE and PI EM can be recorded on the CRF using PISPID EMSPID and/or PIAENOEMAENO. PIAENO EMAENO is a CDASH data capture variable that is not submitted in SDTM-based datasets, but is used to create a RELREC that links the event records.
- PIESTDTC EMESTDTC is the date/time of the device event. PIEENDTC EMEENDTC (end date/time) 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 PIDECOD EMDECOD can be included as non-standard variables.
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