SDTM.MK

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. 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".
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	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	Timing	Perm	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.
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	Timing	Perm	Date/time for a fixed reference time point defined by MKTPTREF.