Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 CM STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 CM DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 CM USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 CM CMSEQ Sequence Number Num Identifier Req Sequence number to ensure uniqueness of subject records within a domain. May be any valid number.
5 CM CMGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 CM CMSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. Example: a number pre-printed on the CRF as an explicit line identifier or record identifier defined in the sponsor's operational database. Example: line number on a concomitant medication page.
7 CM CMTRT Reported Name of Drug, Med, or Therapy Char Topic Req Verbatim medication name that is either pre-printed or collected on a CRF.
8 CM CMMODIFY Modified Reported Name Char Synonym Qualifier Perm If CMTRT is modified to facilitate coding, then CMMODIFY will contain the modified text.
9 CM CMDECOD Standardized Medication Name Char Synonym Qualifier Perm Standardized 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.
10 CM CMCAT Category for Medication Char Grouping Qualifier Perm Used to define a category of medications/treatment. Examples: "PRIOR", "CONCOMITANT", "ANTI-CANCER MEDICATION", or "GENERAL CONMED".
11 CM CMSCAT Subcategory for Medication Char Grouping Qualifier Perm A further categorization of medications/treatment. Examples: "CHEMOTHERAPY", "HORMONAL THERAPY", "ALTERNATIVE THERAPY".
12 CM CMPRESP CM Pre-specified Char C66742 Variable Qualifier Perm Used to indicate whether ("Y"/null) information about the use of a specific medication was solicited on the CRF.
13 CM CMOCCUR CM Occurrence Char C66742 Record Qualifier Perm When the use of a specific medication is solicited. CMOCCUR is used to indicate whether or not ("Y"/"N") use of the medication occurred. Values are null for medications not specifically solicited.
14 CM CMSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate that a question about the occurrence of a pre-specified intervention was not answered. Should be null or have a value of "NOT DONE".
15 CM CMREASND Reason Medication Not Collected Char Record Qualifier Perm Reason not done. Used in conjunction with CMSTAT when value is "NOT DONE".
16 CM CMINDC Indication Char Record Qualifier Perm Denotes why a medication was taken or administered. Examples: "NAUSEA", "HYPERTENSION".
17 CM CMCLAS Medication Class Char Variable Qualifier Perm Drug 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, or omit CMCLAS.
18 CM CMCLASCD Medication Class Code Char Variable Qualifier Perm Class 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, or omit CMCLASCD.
19 CM CMDOSE Dose per Administration Num Record Qualifier Perm Amount of CMTRT given. Not populated when CMDOSTXT is populated.
20 CM CMDOSTXT Dose Description Char Record Qualifier Perm Dosing 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.
21 CM CMDOSU Dose Units Char C71620 Variable Qualifier Perm Units for CMDOSE, CMDOSTOT, or CMDOSTXT. Examples: "ng", "mg", or "mg/kg".
22 CM CMDOSFRM Dose Form Char C66726 Variable Qualifier Perm Dose form for CMTRT. Examples: "TABLET", "LOTION".
23 CM CMDOSFRQ Dosing Frequency per Interval Char C71113 Variable Qualifier Perm Usually expressed as the number of repeated administrations of CMDOSE within a specific time period. Examples: "BID" (twice daily), "Q12H" (every 12 hours).
24 CM CMDOSTOT Total Daily Dose Num Record Qualifier Perm Total 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.
25 CM CMDOSRGM Intended Dose Regimen Char Variable Qualifier Perm Text description of the (intended) schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF".
26 CM CMROUTE Route of Administration Char C66729 Variable Qualifier Perm Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS".
27 CM CMADJ Reason for Dose Adjustment Char Record Qualifier Perm Describes reason or explanation of why a dose is adjusted. Examples: "ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON".
28 CM CMRSDISC Reason the Intervention Was Discontinued Char Record Qualifier Perm When dosing of a treatment is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the treatment.
29 CM TAETORD Planned Order of Element within Arm Num Timing Perm Number 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.
30 CM EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the medication administration. Null for medications that started before study participation.
31 CM CMSTDTC Start Date/Time of Medication Char ISO 8601 Timing Perm Start date/time of the medication administration represented in ISO 8601 character format.
32 CM CMENDTC End Date/Time of Medication Char ISO 8601 Timing Perm End date/time of the medication administration represented in ISO 8601 character format.
33 CM CMSTDY Study Day of Start of Medication Num Timing Perm Study day of start of medication relative to the sponsor-defined RFSTDTC.
34 CM CMENDY Study Day of End of Medication Num Timing Perm Study day of end of medication relative to the sponsor-defined RFSTDTC.
35 CM CMDUR Duration Char ISO 8601 Timing Perm Collected duration for a treatment episode. Used only if collected on the CRF and not derived from start and end date/times.
36 CM CMSTRF Start Relative to Reference Period Char C66728 Timing Perm Describes the start of the medication relative to sponsor-defined reference period. The sponsor-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.
37 CM CMENRF End Relative to Reference Period Char C66728 Timing Perm Describes the end of the medication relative to the sponsor-defined reference period. The sponsor-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.
38 CM CMSTRTPT Start Relative to Reference Time Point Char C66728 Timing Perm Identifies the start of the medication as being before or after the sponsor-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.
39 CM CMSTTPT Start Reference Time Point Char Timing Perm Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by CMSTRTPT. Examples: "2003-12-15" or "VISIT 1".
40 CM CMENRTPT End Relative to Reference Time Point Char C66728 Timing Perm Identifies the end of the medication as being before or after the sponsor-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.
41 CM CMENTPT End Reference Time Point Char Timing Perm Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by CMENRTPT. Examples: "2003-12-25" or "VISIT 2".