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Metadataspec
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keysNotes;Core;Description
shareqc_sdtmig34sdtm4tig10_ds
ClassInterventions
DomainCM
Variable NameVariable LabelTypeControlled Terms, Codelist, or Format1RoleCDISC 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
CMSPIDSponsorApplicant-Defined IdentifierChar
IdentifierSponsorApplicant-defined reference number. Example: a number preprinted on the CRF as an explicit line identifier or record identifier defined in the sponsorapplicant'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. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document. 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/treatmenttreatments/products). Examples: "PRIOR", "CONCOMITANT", "ANTI-CANCER MEDICATION", "GENERAL CONMED".Perm
CMSCATSubcategory for MedicationChar
Grouping QualifierA further categorization of interventions (e.g., medications/treatments/treatmentproducts). 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 follow Section 4.2.8.3, Multiple Values for a Non-result Qualifier Variable, 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 follow Section 4.2.8.3, Multiple Values for a Non-result Qualifier Variable, 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 sponsorapplicant-defined RFSTDTC.Perm
CMENDYStudy Day of End of MedicationNum
TimingStudy day of end of medication relative to the sponsorapplicant-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 sponsorapplicant-defined reference period. The sponsorapplicant-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.Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.

Perm
CMENRFEnd Relative to Reference PeriodChar(STENRF)Timing

Describes the end of the medication relative to the sponsorapplicant-defined reference period. The sponsorapplicant-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.

Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.

Perm
CMSTRTPTStart Relative to Reference Time PointChar(STENRF)Timing

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

Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.

Perm
CMSTTPTStart Reference Time PointChar
TimingDescription or date/time in ISO 8601 character format of the sponsorapplicant-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 sponsorapplicant-defined reference time point defined by variable CMENTPT.Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.

Perm
CMENTPTEnd Reference Time PointChar
TimingDescription or date/time in ISO 8601 character format of the sponsorapplicant-defined reference point referred to by CMENRTPT. Examples: "2003-12-25", "VISIT 2".Perm
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.