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  1. The EMYN variable with the question text “Were any tobacco product device 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 Applicants 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 applicant’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 5a3a.
      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. CDASHIG Action Taken Variables
    1. Collection
      2. variables AEACN, AECONTRT, AEACNDEV, AEACNOYN, and AEACNOTH are
    2. variable EMACNDEV is used to collect the action taken
      3. as the result of an AE.
    3. AEACN describes action taken with study product as a result of the event. It is expected that a response will be provided for this question for all AEs. When a study includes exposure to multiple products, then corresponding variables should be created to capture the action taken for each product. 
      4. AEACNOTH describes Other Action(s) taken in response to an adverse event that are unrelated to study product exposure changes or treatment given because of this adverse event
    4. with the tobacco product device. The tobacco product device may or may not be the device under study. This field is usually
      5. collected as
    5. a free-text field. If possible/desired, the applicant can create applicant-defined controlled terminology.
      6. The collection variable AEACNOYN is used in conjunction with AEACNOTH to assist in the cleaning of data and in confirming that AEACNOTH is not missing. AEACNOYN is not included as part of the SDTMIG AE domain for submission and is annotated as "NOT SUBMITTED" on the CRF. The CDASHIG variable AEACNOYN should only be used on the AE CRF.
    6. AECONTRT indicates if any treatments were received because of this adverse event. If "Yes" is answered for this question, any drugs used are recorded on the Concomitant Medications CRF and any procedures performed are recorded on the Procedure CRF. The collection variables CMAENO (on the CM CRF) can be collected to identify the adverse event associated with this treatment by recording the appropriate AESPID. The RELREC dataset can be used to identify this relationship. 
      7. 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 product 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.