Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 MK 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 MK 2 DOMAIN Domain Abbreviation Char MK Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 MK 3 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
SDTMIG 3.3 MK 4 MKSEQ Sequence Number Num Identifier Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1. Req
SDTMIG 3.3 MK 5 MKGRPID Group ID Char Identifier Used to link together a block of related records within a subject in a domain. Perm
SDTMIG 3.3 MK 6 MKREFID Reference ID Char Identifier Optional internal or external identifier such as lab specimen ID or a medical image. Perm
SDTMIG 3.3 MK 7 MKSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. Example: Preprinted line identifier on a Concomitant Medications page. Perm
SDTMIG 3.3 MK 8 MKLNKID Link ID Char Identifier Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. Perm
SDTMIG 3.3 MK 9 MKLNKGRP Link Group ID Char Identifier Identifier used to link related records across domains. This will usually be a many-to-one relationship. Perm
SDTMIG 3.3 MK 10 MKTESTCD Short Name of Musculoskeletal Test Char (MUSCTSCD) Topic Short character value for MKTEST used as a column name when converting a dataset from a vertical format to a horizontal format. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MKTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MKTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "TNDRIND", "SWLLIND", "SGJSNSCR". Req
SDTMIG 3.3 MK 11 MKTEST Name of Musculoskeletal Test Char (MUSCTS) Synonym Qualifier Long name For MKTESTCD. Examples: "Tenderness Indicator", "Swollen Indicator", "Sharp/Genant JSN Score". Req
SDTMIG 3.3 MK 12 MKCAT Category for Musculoskeletal Test Char Grouping Qualifier Used to define a category of topic-variable values. Examples: "SWOLLEN/TENDER JOINT ASSESSMENT". Perm
SDTMIG 3.3 MK 13 MKSCAT Subcategory for Musculoskeletal Test Char Grouping Qualifier Used to define a further categorization of MKCAT values. Perm
SDTMIG 3.3 MK 14 MKPOS Position of Subject Char (POSITION) Record Qualifier Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". Perm
SDTMIG 3.3 MK 15 MKORRES Result or Finding in Original Units Char Result Qualifier Result of the measurement or finding as originally received or collected. Exp
SDTMIG 3.3 MK 16 MKORRESU Original Units Char (UNIT) Variable Qualifier Unit for MKORRES. Perm
SDTMIG 3.3 MK 17 MKSTRESC Character Result/Finding in Std Format Char Result Qualifier Contains the result value for all findings, copied or derived from MKORRES in a standard format or in standard units. MKSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in MKSTRESN. For example, if various tests have results "NONE", "NEG", and "NEGATIVE" in MKORRES and these results effectively have the same meaning, they could be represented in standard format in MKSTRESC as "NEGATIVE". Exp
SDTMIG 3.3 MK 18 MKSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Used for continuous or numeric results or findings in standard format; copied in numeric format from MKSTRESC. MKSTRESN should store all numeric test results or findings. Perm
SDTMIG 3.3 MK 19 MKSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for MKSTRESC and MKSTRESN. Perm
SDTMIG 3.3 MK 20 MKSTAT Completion Status Char (ND) Record Qualifier Used to indicate that a question was not asked or a test was not done, or that a test was attempted but did not generate a result. Should be null if a result exists in MKORRES. Perm
SDTMIG 3.3 MK 21 MKREASND Reason Not Done Char Record Qualifier Reason not done. Used in conjunction with MKSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 MK 22 MKLOC Location Used for the Measurement Char (LOC) Record Qualifier Anatomical location of the subject relevant to the collection of the measurement. Examples: "INTERPHALANGEAL JOINT 1", "SHOULDER JOINT". Exp
SDTMIG 3.3 MK 23 MKLAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". Perm
SDTMIG 3.3 MK 24 MKDIR Directionality Char (DIR) Variable Qualifier Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". Perm
SDTMIG 3.3 MK 25 MKMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. Examples: "X-RAY", "MRI", "CT SCAN". Perm
SDTMIG 3.3 MK 26 MKLOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. Exp
SDTMIG 3.3 MK 27 MKBLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. Should be "Y" or null. Note that MKBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 MK 28 MKDRVFL Derived Flag Char (NY) Record Qualifier Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be "Y" or null. Perm
SDTMIG 3.3 MK 29 MKEVAL Evaluator Char (EVAL) Record Qualifier Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "RADIOLOGIST". Perm
SDTMIG 3.3 MK 30 MKEVALID Evaluator Identifier Char (MEDEVAL) Variable Qualifier Used to distinguish multiple evaluators with the same role recorded in MKEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". Perm
SDTMIG 3.3 MK 31 VISITNUM Visit Number Num Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 MK 32 VISIT Visit Name Char Timing Protocol-defined description of a clinical encounter. Perm
SDTMIG 3.3 MK 33 VISITDY Planned Study Day of Visit Num Timing Planned study day of VISIT. Should be an integer. Perm
SDTMIG 3.3 MK 34 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 assessment was made. Perm
SDTMIG 3.3 MK 35 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the assessment was made. Perm
SDTMIG 3.3 MK 36 MKDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of an observation. Exp
SDTMIG 3.3 MK 37 MKDY Study Day of Visit/Collection/Exam Num Timing Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 MK 38 MKTPT Planned Time Point Name Char Timing Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See MKTPTNUM and MKTPTREF. Perm
SDTMIG 3.3 MK 39 MKTPTNUM Planned Time Point Number Num Timing Numeric version of planned time point used in sorting. Perm
SDTMIG 3.3 MK 40 MKELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned Elapsed time relative to a planned fixed reference (MKTPTREF) such as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration. Perm
SDTMIG 3.3 MK 41 MKTPTREF Time Point Reference Char Timing Description of the fixed reference point referred to by MKELTM, MKTPTNUM, and MKTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". Perm
SDTMIG 3.3 MK 42 MKRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by MKTPTREF. Perm