SDTM.VS

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	VS	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	VS	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	VS	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	VS	VSSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	VS	VSGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	VS	VSSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database.
7	VS	VSTESTCD	Vital Signs Test Short Name	Char	C66741	Topic	Req	Short name of the measurement, test, or examination described in VSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in VSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). VSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SYSBP", "DIABP", "BMI".
8	VS	VSTEST	Vital Signs Test Name	Char	C67153	Synonym Qualifier	Req	Verbatim name of the test or examination used to obtain the measurement or finding. The value in VSTEST cannot be longer than 40 characters. Examples: "Systolic Blood Pressure", "Diastolic Blood Pressure", "Body Mass Index".
9	VS	VSCAT	Category for Vital Signs	Char		Grouping Qualifier	Perm	Used to define a category of related records.
10	VS	VSSCAT	Subcategory for Vital Signs	Char		Grouping Qualifier	Perm	A further categorization of a measurement or examination.
11	VS	VSPOS	Vital Signs Position of Subject	Char	C71148	Record Qualifier	Perm	Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".
12	VS	VSORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the vital signs measurement as originally received or collected.
13	VS	VSORRESU	Original Units	Char	C66770	Variable Qualifier	Exp	Original units in which the data were collected. The unit for VSORRES. Examples: "in", "LB", "beats/min".
14	VS	VSSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	Contains the result value for all findings, copied or derived from VSORRES in a standard format or standard units. VSSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in VSSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in VSORRES, and these results effectively have the same meaning, they could be represented in standard format in VSSTRESC as "NEGATIVE".
15	VS	VSSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Exp	Used for continuous or numeric results or findings in standard format; copied in numeric format from VSSTRESC. VSSTRESN should store all numeric test results or findings.
16	VS	VSSTRESU	Standard Units	Char	C66770	Variable Qualifier	Exp	Standardized unit used for VSSTRESC and VSSTRESN.
17	VS	VSSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that a vital sign measurement was not done. Should be null if a result exists in VSORRES.
18	VS	VSREASND	Reason Not Performed	Char		Record Qualifier	Perm	Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with VSSTAT when value is "NOT DONE".
19	VS	VSLOC	Location of Vital Signs Measurement	Char	C74456	Record Qualifier	Perm	Location relevant to the collection of vital signs measurement. Example: "ARM" for blood pressure.
20	VS	VSLAT	Laterality	Char	C99073	Result Qualifier	Perm	Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
21	VS	VSLOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Exp	Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null.
22	VS	VSBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	Indicator used to identify a baseline value. Should be "Y" or null. Note that VSBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.
23	VS	VSDRVFL	Derived Flag	Char	C66742	Record Qualifier	Perm	Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records or that do not come from the CRF are examples of records that would be derived for the submission datasets. If VSDRVFL = "Y," then VSORRES may be null, with VSSTRESC and (if numeric) VSSTRESN having the derived value.
24	VS	VSTOX	Toxicity	Char		Variable Qualifier	Perm	Description of toxicity quantified by VSTOXGR. The sponsor is expected to provide the name of the scale and version used to map the terms, utilizing the external codelist element in the Define-XML document.
25	VS	VSTOXGR	Standard Toxicity Grade	Char		Record Qualifier	Perm	Records toxicity grade value using a standard toxicity scale (e.g., NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2", not "Grade 2"). The sponsor is expected to provide the name of the scale and version used to map the terms, utilizing the external codelist element in the Define-XML document.
26	VS	VSCLSIG	Clinically Significant, Collected	Char	C66742	Record Qualifier	Perm	Used to indicate whether a collected observation is clinically significant based on judgment.
27	VS	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
28	VS	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
29	VS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
30	VS	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the element within the arm.
31	VS	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time at which the assessment was made.
32	VS	VSDTC	Date/Time of Measurements	Char	ISO 8601 datetime or interval	Timing	Exp	Date and time of the vital signs assessment represented in ISO 8601 character format.
33	VS	VSDY	Study Day of Vital Signs	Num		Timing	Perm	Study day of vital signs measurements, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.
34	VS	VSTPT	Planned Time Point Name	Char		Timing	Perm	Text description of time when measurement should be taken. This may be represented as an elapsed time relative to a fixed reference point (e.g., time of last dose). See VSTPTNUM and VSTPTREF. Examples: "START", "5 MIN POST".
35	VS	VSTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of VSTPT to aid in sorting.
36	VS	VSELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Perm	Planned elapsed time (in ISO 8601) relative to a planned fixed reference (VSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 Duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by VSTPTREF, "PT8H" to represent the period of 8 hours after the reference point indicated by VSTPTREF.
37	VS	VSTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point referred to by VSELTM, VSTPTNUM, and VSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
38	VS	VSRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing	Perm	Date/time of the reference time point, VSTPTREF.