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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharCMIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
CMSEQSequence NumberNum
IdentifierSequence number to ensure uniqueness of subject records within a domain. May be any valid number.Req
CMGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
CMSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. Example: a number preprinted on the CRF as an explicit line identifier or record identifier defined in the applicant's operational database. Example: line number on a concomitant medication page.Perm
CMTRTReported Name of Drug, Med, or TherapyChar
TopicVerbatim medication name that is either preprinted or collected on a CRF.Req
CMMODIFYModified Reported NameChar
Synonym QualifierIf CMTRT is modified to facilitate coding, then CMMODIFY will contain the modified text.Perm
CMDECODStandardized Medication NameChar
Synonym QualifierStandardized or dictionary-derived text description of CMTRT or CMMODIFY. Equivalent to the generic drug name in WHO Drug. If an intervention term does not have a decode value in the dictionary, then CMDECOD will be left blank.Perm
CMCATCategory for MedicationChar
Grouping QualifierUsed to define a category of interventions (e.g., medications/treatments/products). Examples: "PRIOR", "CONCOMITANT", "ANTI-CANCER MEDICATION", "GENERAL CONMED".Perm
CMSCATSubcategory for MedicationChar
Grouping QualifierA further categorization of interventions (e.g., medications/treatments/products). Examples: "CHEMOTHERAPY", "HORMONAL THERAPY", "ALTERNATIVE THERAPY".Perm
CMPRESPCM Pre-specifiedChar(NY)Variable QualifierUsed to indicate whether ("Y"/null) information about the use of a specific medication was solicited on the CRF.Perm
CMOCCURCM OccurrenceChar(NY)Record QualifierWhen the use of a specific medication is solicited. CMOCCUR is used to indicate whether ("Y"/"N") use of the medication occurred. Values are null for medications not specifically solicited.Perm
CMSTATCompletion StatusChar(ND)Record QualifierUsed to indicate that a question about the occurrence of a prespecified intervention was not answered. Should be null or have a value of "NOT DONE".Perm
CMREASNDReason Medication Not CollectedChar
Record QualifierReason not done. Used in conjunction with CMSTAT when value is "NOT DONE".Perm
CMINDCIndicationChar
Record QualifierDenotes why a medication was taken or administered. Examples: "NAUSEA", "HYPERTENSION".Perm
CMCLASMedication ClassChar
Variable QualifierDrug class. May be obtained from coding. When coding to a single class, populate with class value. If using a dictionary and coding to multiple classes, then populate multiple values per TIG guidance or omit CMCLAS.Perm
CMCLASCDMedication Class CodeChar
Variable QualifierClass code corresponding to CMCLAS. Drug class. May be obtained from coding. When coding to a single class, populate with class code. If using a dictionary and coding to multiple classes, then populate multiple values per TIG guidance or omit CMCLASCD.Perm
CMDOSEDose per AdministrationNum
Record QualifierAmount of CMTRT given. Not populated when CMDOSTXT is populated.Perm
CMDOSTXTDose DescriptionChar
Record QualifierDosing amounts or a range of dosing information collected in text form. Units may be stored in CMDOSU. Examples: "200-400", "15-20". Not populated when CMDOSE is populated.Perm
CMDOSUDose UnitsChar(UNIT)Variable QualifierUnits for CMDOSE, CMDOSTOT, or CMDOSTXT. Examples: "ng", "mg", "mg/kg".Perm
CMDOSFRMDose FormChar(FRM)Variable QualifierDose form for CMTRT. Examples: "TABLET", "LOTION".Perm
CMDOSFRQDosing Frequency per IntervalChar(FREQ)Record QualifierUsually expressed as the number of repeated administrations of CMDOSE within a specific time period. Examples: "BID" (twice daily), "Q12H" (every 12 hours).Perm
CMDOSTOTTotal Daily DoseNum
Record QualifierTotal daily dose of CMTRT using the units in CMDOSU. Used when dosing is collected as total daily dose. Total dose over a period other than day could be recorded in a separate supplemental qualifier variable.Perm
CMDOSRGMIntended Dose RegimenChar
Record QualifierText description of the (intended) schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF".Perm
CMROUTERoute of AdministrationChar(ROUTE)Variable QualifierRoute of administration for the intervention. Examples: "ORAL", "INTRAVENOUS".Perm
CMADJReason for Dose AdjustmentChar
Record QualifierDescribes reason or explanation of why a dose is adjusted. Examples: "ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON".Perm
CMRSDISCReason the Intervention Was DiscontinuedChar
Record QualifierWhen dosing of a treatment is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the treatment.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the element within the arm for the element in which the medication administration started. Null for medications that started before study participation.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the medication administration. Null for medications that started before study participation.Perm
CMSTDTCStart Date/Time of MedicationCharISO 8601 datetime or intervalTimingStart date/time of the medication administration represented in ISO 8601 character format.Perm
CMENDTCEnd Date/Time of MedicationCharISO 8601 datetime or intervalTimingEnd date/time of the medication administration represented in ISO 8601 character format.Perm
CMSTDYStudy Day of Start of MedicationNum
TimingStudy day of start of medication relative to the applicant-defined RFSTDTC.Perm
CMENDYStudy Day of End of MedicationNum
TimingStudy day of end of medication relative to the applicant-defined RFSTDTC.Perm
CMDURDurationCharISO 8601 durationTimingCollected duration for a treatment episode. Used only if collected on the CRF and not derived from start and end date/times.Perm
CMSTRFStart Relative to Reference PeriodChar(STENRF)Timing

Describes the start of the medication relative to applicant-defined reference period. The applicant-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics). If information such as "PRIOR" was collected, this information may be translated into CMSTRF.

Perm
CMENRFEnd Relative to Reference PeriodChar(STENRF)Timing

Describes the end of the medication relative to the applicant-defined reference period. The applicant-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics). If information such as "PRIOR", "ONGOING, or "CONTINUING" was collected, this information may be translated into CMENRF.

Perm
CMSTRTPTStart Relative to Reference Time PointChar(STENRF)Timing

Identifies the start of the medication as being before or after the applicant-defined reference time point defined by variable CMSTTPT.

Perm
CMSTTPTStart Reference Time PointChar
TimingDescription or date/time in ISO 8601 character format of the applicant-defined reference point referred to by CMSTRTPT. Examples: "2003-12-15", "VISIT 1".Perm
CMENRTPTEnd Relative to Reference Time PointChar(STENRF)Timing

Identifies the end of the medication as being before or after the applicant-defined reference time point defined by variable CMENTPT.

Perm
CMENTPTEnd Reference Time PointChar
TimingDescription or date/time in ISO 8601 character format of the applicant-defined reference point referred to by CMENRTPT. Examples: "2003-12-25", "VISIT 2".Perm

Assumptions

  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 WHODrug are longer than 200 characters, split the values at semicolons rather than spaces when implementing guidance in Section 2.8.7.1, General Guidance. TOBA-251 - Getting issue details... STATUS
  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.

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