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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 MK STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 MK DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 MK 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 MK MKSEQ Sequence Number Num Identifier Req 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.
5 MK MKGRPID Group ID Char Identifier Perm Used to link together a block of related records within a subject in a domain.
6 MK MKREFID Reference ID Char Identifier Perm Optional internal or external identifier such as lab specimen ID or a medical image.
7 MK MKSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier. Example: Preprinted line identifier on a Concomitant Medications page.
8 MK MKLNKID Link ID Char Identifier Perm Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
9 MK MKLNKGRP Link Group ID Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
10 MK MKTESTCD Short Name of Musculoskeletal Test Char C127269 Topic Req Short character value for MKTEST used as a column name when converting a dataset from a vertical format 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".
11 MK MKTEST Name of Musculoskeletal Test Char C127270 Synonym Qualifier Req Long name For MKTESTCD. Examples: "Tenderness Indicator", "Swollen Indicator", "Sharp/Genant JSN Score".
12 MK MKCAT Category for Musculoskeletal Test Char Grouping Qualifier Perm Used to define a category of topic-variable values. Examples: "SWOLLEN/TENDER JOINT ASSESSMENT".
13 MK MKSCAT Subcategory for Musculoskeletal Test Char Grouping Qualifier Perm Used to define a further categorization of MKCAT values.
14 MK MKPOS Position of Subject Char C71148 Record Qualifier Perm Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".
15 MK MKORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected.
16 MK MKORRESU Original Units Char C71620 Variable Qualifier Perm Unit for MKORRES.
17 MK MKSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp 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".
18 MK MKSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Perm 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.
19 MK MKSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized units used for MKSTRESC and MKSTRESN.
20 MK MKSTAT Completion Status Char C66789 Record Qualifier Perm 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.
21 MK MKREASND Reason Not Done Char Record Qualifier Perm Reason not done. Used in conjunction with MKSTAT when value is "NOT DONE".
22 MK MKLOC Location Used for the Measurement Char C74456 Record Qualifier Exp Anatomical location of the subject relevant to the collection of the measurement. Examples: "INTERPHALANGEAL JOINT 1", "SHOULDER JOINT".
23 MK MKLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
24 MK MKDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
25 MK MKMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method of the test or examination. Examples: "X-RAY", "MRI", "CT SCAN".
26 MK MKLOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Exp Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
27 MK MKBLFL Baseline Flag Char C66742 Record Qualifier Perm 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.
28 MK MKDRVFL Derived Flag Char C66742 Record Qualifier Perm 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.
29 MK MKEVAL Evaluator Char C78735 Record Qualifier Perm 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".
30 MK MKEVALID Evaluator Identifier Char C96777 Variable Qualifier Perm Used to distinguish multiple evaluators with the same role recorded in MKEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2".
31 MK VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
32 MK VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
33 MK VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of VISIT. Should be an integer.
34 MK 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 assessment was made.
35 MK EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the assessment was made.
36 MK MKDTC Date/Time of Collection Char ISO 8601 datetime or interval Timing Exp Collection date and time of an observation.
37 MK MKDY Study Day of Visit/Collection/Exam Num Timing Perm Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
38 MK MKTPT Planned Time Point Name Char Timing Perm 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.
39 MK MKTPTNUM Planned Time Point Number Num Timing Perm Numeric version of planned time point used in sorting.
40 MK MKELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 duration Timing Perm Planned Elapsed time relative to a planned fixed reference (MKTPTREF; e.g., "PREVIOUS DOSE", "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.
41 MK MKTPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by MKELTM, MKTPTNUM, and MKTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
42 MK MKRFTDTC Date/Time of Reference Time Point Char ISO 8601 datetime or interval Timing Perm Date/time for a fixed reference time point defined by MKTPTREF.