| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | CM | Identifier | Two-character abbreviation for the domain. | Req |
| USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req |
| CMSEQ | Sequence Number | Num |
| Identifier | Sequence number to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| CMGRPID | Group ID | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm |
| CMSPID | Applicant-Defined Identifier | Char |
| Identifier | Applicant-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 |
| CMTRT | Reported Name of Drug, Med, or Therapy | Char |
| Topic | Verbatim medication name that is either preprinted or collected on a CRF. | Req |
| CMMODIFY | Modified Reported Name | Char |
| Synonym Qualifier | If CMTRT is modified to facilitate coding, then CMMODIFY will contain the modified text. | Perm |
| CMDECOD | Standardized Medication Name | Char |
| Synonym Qualifier | Standardized 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 |
| CMCAT | Category for Medication | Char |
| Grouping Qualifier | Used to define a category of interventions (e.g., medications/treatments/treatmentproducts). Examples: "PRIOR", "CONCOMITANT", "ANTI-CANCER MEDICATION", "GENERAL CONMED". | Perm |
| CMSCAT | Subcategory for Medication | Char |
| Grouping Qualifier | A further categorization of interventions (e.g., medications/treatments/treatmentproducts). Examples: "CHEMOTHERAPY", "HORMONAL THERAPY", "ALTERNATIVE THERAPY". | Perm |
| CMPRESP | CM Pre-specified | Char | (NY) | Variable Qualifier | Used to indicate whether ("Y"/null) information about the use of a specific medication was solicited on the CRF. | Perm |
| CMOCCUR | CM Occurrence | Char | (NY) | Record Qualifier | When 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 |
| CMSTAT | Completion Status | Char | (ND) | Record Qualifier | Used 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 |
| CMREASND | Reason Medication Not Collected | Char |
| Record Qualifier | Reason not done. Used in conjunction with CMSTAT when value is "NOT DONE". | Perm |
| CMINDC | Indication | Char |
| Record Qualifier | Denotes why a medication was taken or administered. Examples: "NAUSEA", "HYPERTENSION". | Perm |
| CMCLAS | Medication Class | Char |
| Variable Qualifier | 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 populate multiple values per TIG guidance or omit CMCLAS. | Perm |
| CMCLASCD | Medication Class Code | Char |
| Variable Qualifier | 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 populate multiple values per TIG guidance or omit CMCLASCD. | Perm |
| CMDOSE | Dose per Administration | Num |
| Record Qualifier | Amount of CMTRT given. Not populated when CMDOSTXT is populated. | Perm |
| CMDOSTXT | Dose Description | Char |
| Record Qualifier | 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. | Perm |
| CMDOSU | Dose Units | Char | (UNIT) | Variable Qualifier | Units for CMDOSE, CMDOSTOT, or CMDOSTXT. Examples: "ng", "mg", "mg/kg". | Perm |
| CMDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for CMTRT. Examples: "TABLET", "LOTION". | Perm |
| CMDOSFRQ | Dosing Frequency per Interval | Char | (FREQ) | Record Qualifier | Usually expressed as the number of repeated administrations of CMDOSE within a specific time period. Examples: "BID" (twice daily), "Q12H" (every 12 hours). | Perm |
| CMDOSTOT | Total Daily Dose | Num |
| Record Qualifier | 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. | Perm |
| CMDOSRGM | Intended Dose Regimen | Char |
| Record Qualifier | Text description of the (intended) schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF". | Perm |
| CMROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS". | Perm |
| CMADJ | Reason for Dose Adjustment | Char |
| Record Qualifier | Describes reason or explanation of why a dose is adjusted. Examples: "ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON". | Perm |
| CMRSDISC | Reason the Intervention Was Discontinued | Char |
| Record Qualifier | When dosing of a treatment is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the treatment. | Perm |
| TAETORD | Planned Order of Element within Arm | Num |
| Timing | 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. | Perm |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the medication administration. Null for medications that started before study participation. | Perm |
| CMSTDTC | Start Date/Time of Medication | Char | ISO 8601 datetime or interval | Timing | Start date/time of the medication administration represented in ISO 8601 character format. | Perm |
| CMENDTC | End Date/Time of Medication | Char | ISO 8601 datetime or interval | Timing | End date/time of the medication administration represented in ISO 8601 character format. | Perm |
| CMSTDY | Study Day of Start of Medication | Num |
| Timing | Study day of start of medication relative to the applicant-defined RFSTDTC. | Perm |
| CMENDY | Study Day of End of Medication | Num |
| Timing | Study day of end of medication relative to the applicant-defined RFSTDTC. | Perm |
| CMDUR | Duration | Char | ISO 8601 duration | Timing | Collected duration for a treatment episode. Used only if collected on the CRF and not derived from start and end date/times. | Perm |
| CMSTRF | Start Relative to Reference Period | Char | (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 |
| CMENRF | End Relative to Reference Period | Char | (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 |
| CMSTRTPT | Start Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the start of the medication as being before or after the applicant-defined reference time point defined by variable CMSTTPT. | Perm |
| CMSTTPT | Start Reference Time Point | Char |
| Timing | Description 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 |
| CMENRTPT | End Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the end of the medication as being before or after the applicant-defined reference time point defined by variable CMENTPT. | Perm |
| CMENTPT | End Reference Time Point | Char |
| Timing | Description 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 |