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SDTMIG v3.3 Metadata Check for Domain Specification Table 1.3.1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. <a href="https://wiki.cdisc.org/x/r37dAg" target="_blank">Release Notes</a>
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 | EX | 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 | |
EXSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
EXGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | |
EXREFID | Reference ID | Char | Identifier | Internal or external identifier (e.g., kit number, bottle label, vial identifier). | Perm | |
EXSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a CRF Page. | Perm | |
EXLNKID | Link ID | Char | Identifier | Identifier used to link related records across domains. | Perm | |
EXLNKGRP | Link Group ID | Char | Identifier | Identifier used to link related, grouped records across domains. | Perm | |
EXTRT | Name of Treatment | Char | * | Topic | Name of the protocol-specified study treatment given during the dosing period for the observation. | Req |
EXCAT | Category of Treatment | Char | * | Grouping Qualifier | Used to define a category of EXTRT values. | Perm |
EXSCAT | Subcategory of Treatment | Char | * | Grouping Qualifier | A further categorization of EXCAT values. | Perm |
EXDOSE | Dose | Num | Record Qualifier | Amount of EXTRT when numeric. Not populated when EXDOSTXT is populated. | Exp | |
EXDOSTXT | Dose Description | Char | Record Qualifier | Amount of EXTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: 200-400. Not populated when EXDOSE is populated. | Perm | |
EXDOSU | Dose Units | Char | (UNIT) | Variable Qualifier | Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified values. Examples: "ng", "mg", "mg/kg", "mg/m2". | Exp |
EXDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for EXTRT. Examples: "TABLET", "LOTION". | Exp |
EXDOSFRQ | Dosing Frequency per Interval | Char | (FREQ) | Variable Qualifier | Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: "Q2H", "QD", "BID". | Perm |
EXDOSRGM | Intended Dose Regimen | Char | Variable Qualifier | Text description of the intended schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF". | Perm | |
EXROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS". | Perm |
EXLOT | Lot Number | Char | Record Qualifier | Lot number of the intervention product. | Perm | |
EXLOC | Location of Dose Administration | Char | (LOC) | Record Qualifier | Specifies location of administration. Examples: "ARM", "LIP". | Perm |
EXLAT | Laterality | Char | (LAT) | Variable Qualifier | Qualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT". | Perm |
EXDIR | Directionality | Char | (DIR) | Variable Qualifier | Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER". | Perm |
EXFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. Examples: "Y", "N". | Perm |
EXADJ | Reason for Dose Adjustment | Char | * | Record Qualifier | Describes reason or explanation of why a dose is adjusted. | Perm |
TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | |
EPOCH | Epoch | Char | (EPOCH) | Timing | Trial Epoch of the Exposure record. Examples: "RUN-IN", "TREATMENT". | Perm |
EXSTDTC | Start Date/Time of Treatment | Char | ISO 8601 | Timing | The date/time when administration of the treatment indicated by EXTRT and EXDOSE began. | Exp |
EXENDTC | End Date/Time of Treatment | Char | ISO 8601 | Timing | The date/time when administration of the treatment indicated by EXTRT and EXDOSE ended. For administrations considered given at a point in time (e.g., oral tablet, pre-filled syringe injection), where only an administration date/time is collected, EXSTDTC should be copied to EXENDTC as the standard representation. | Exp |
EXSTDY | Study Day of Start of Treatment | Num | Timing | Study day of EXSTDTC relative to DM.RFSTDTC. | Perm | |
EXENDY | Study Day of End of Treatment | Num | Timing | Study day of EXENDTC relative to DM.RFSTDTC. | Perm | |
EXDUR | Duration of Treatment | Char | ISO 8601 | Timing | Collected duration of administration. Used only if collected on the CRF and not derived from start and end date/times. | Perm |
EXTPT | Planned Time Point Name | Char | Timing |
| Perm | |
EXTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EXTPT to aid in sorting. | Perm | |
EXELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time relative to the planned fixed reference (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time. | Perm |
EXTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EXELTM, EXTPTNUM, and EXTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL. | Perm | |
EXRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/time for a fixed reference time point defined by EXTPTREF. | Perm |
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