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changes.mady.by.user Christine Connolly

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  1. 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.
  2. 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.
  3. 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 . See Section 2.8.10.1, Adverse Events (AE), for more information ). The relationship between AE and EM can be recorded on the CRF using EMSPID 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.
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    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-557
    and/or EMAENO. EMAENO
    Jira
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    serverIssue Tracker (JIRA)
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    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.
  4. EMSTDTC is the date/time of the device event. EMENDTC (end date/time)
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
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    can be used, for example, if a malfunction occurs during a deployment and it is repaired later.
  5. 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.