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  1. The structure of the CM domain is 1 record per medication intervention episode, constant-dosing interval, or prespecified medication assessment per subject. It is the applicant's responsibility to define an intervention episode. This definition may vary based on the applicant's requirements for review and analysis. The submission dataset structure may differ from the structure used for collection. One common approach is to submit a new record when there is a change in the dosing regimen. Another approach is to collapse all records for a medication to a summary level with either a dose range or the highest dose level. Other approaches may also be reasonable as long as they meet the applicant's evaluation requirements.
  2. CM description and coding
    1. CMTRT is the topic variable and captures the name of the concomitant medication/therapy or the prespecified term used to collect information about the occurrence of any of a group of medications and/or therapies. It is a required variable and must have a value. CMTRT only includes the medication/therapy name and does not include dosage, formulation, or other qualifying information. For example, “ASPIRIN 100MG TABLET” is not a valid value for CMTRT. This example should be expressed as CMTRT= “ASPIRIN”, CMDOSE= “100”, CMDOSU= “MG”, and CMDOSFRM= “TABLET”. When referring to a prespecified group of medications/therapies, CMTRT contains the description of the group used to solicit the occurrence response.
    2. CMMODIFY should be included if the applicant’s procedure permits modification of a verbatim term for coding.
    3. CMDECOD is the standardized medication/therapy term derived by the applicant from the coding dictionary. It is expected that the reported term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard dictionary. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document.
    4. When CMDECOD values from the WHODrug Dictionary are longer than 200 characters, split the values at semicolons rather than spaces when implementing guidance in Section 2.8.7.1, General Guidance.
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  3. Prespecified terms; presence or absence of concomitant medications
    1. Information on concomitant medications is generally collected in 2 different ways, either by recording free text or using a prespecified list of terms. Because the solicitation of information on specific concomitant medications may affect the frequency at which they are reported, the fact that a specific medication was solicited may be of interest to reviewers. CMPRESP and CMOCCUR are used together to indicate whether the intervention in CMTRT was prespecified and whether it occurred, respectively.
    2. CMOCCUR is used to indicate whether a prespecified medication was used. A value of "Y" indicates that the medication was used and "N" indicates that it was not.
    3. If a medication was not prespecified, the value of CMOCCUR should be null. CMPRESP and CMOCCUR are permissible fields and may be omitted from the dataset if all medications were collected as free text. Values of CMOCCUR may also be null for prespecified medications if no Y/N response was collected; in such cases, CMSTAT = "NOT DONE", and CMREASND could be used to describe the reason the answer was missing.
  4. Variables for timing relative to a time point
    1. CMSTRTPT, CMSTTPT, CMENRTPT, and CMENTPT may be populated as necessary to indicate when a medication was used relative to specified time points. For example, assume a subject uses birth control medication. The subject has used the same medication for many years and continues to do so. The date the subject began using the medication (or at least a partial date) would be stored in CMSTDTC. CMENDTC is null because the end date is unknown/has not yet happened. This fact can be recorded by setting CMENTPT = "2007-04-30" (the date the assessment was made) and CMENRTPT = "ONGOING".
  5. Although any identifier variables, timing variables, or interventions general observation-class qualifiers may be added to the CM domain, the following qualifiers would generally not be used: --MOOD, --LOT.