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  1. The EMYN variable with the question text “Were any tobacco product events?” is intended to assist in the cleaning of data and in confirming that there are no missing values. This collection variable will not be represented in the tabulation dataset.
  2. Coding 
    1. EMDECOD is the preferred term derived by the applicant from the coding dictionary. It is a required tabulation variable and must have a value. It is expected that the reported term (EMTERM) will be coded using a dictionary. Sponsors are expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes.
    2. EMMODIFY is a permissible tabulation variable and should be included if the sponsor’s coding procedure permits modification of a verbatim term. The modified term is listed in EMMODIFY. The variable should be populated per the applicants’s coding procedure.
  3. Relative Timing Variables
    1. The EMONGO field does not map directly to a tabulation variable, but it may be used to derive a value into a tabulation relative timing variable such as EMENRF or EMENRTPT. When populating EMENRF, if the EMONGO field is checked, a value of "DURING", "AFTER", or "DURING/AFTER" may be derived, as appropriate. When populating EMENRTPT, if the EMONGO field is checked, the value of "ONGOING" may be derived. EMENRTPT must refer to a time-point anchor as described in EMENTPT.
    2. EMONGO is a special-use case of "Yes/No", where the question is usually presented as a single possible response of "Yes" when there is no applicable end date at the time of collection.
      1. In this case, if the box is checked and the end date is blank, the desired tabulation relative timing variable can be derived according to assumption 5a.
      2. If the box is not checked (EMONGO is NULL) and an end date is present, no tabulation relative timing variable will be derived.
  4. Action Taken Variables
    1. Collection variable, AEACNDEV, is used to collect the action taken as the result of a device event. AEACNDEV describes action taken with respect to a device in a study, which may or may not be the device under study. This field is usually collected as a free-text field. If possible/desired, the applicant can create applicant-defined controlled terminology.
  5. If a malfunction or other event results in an adverse event, then that information should be recorded in the AE domain. The relationship between the AE and EM can be recorded on the CRF using EMSPID and/or EMAENO. EMAENO would be a data capture (CDASH) variable that is not submitted in SDTM-based datasets but is used to create a RELREC that links the event records.