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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
| DOMAIN | Domain Abbreviation | Char | VS | 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 | |
| VSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
| VSGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | |
| VSSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. | Perm | |
| VSTESTCD | Vital Signs Test Short Name | Char | (VSTESTCD) | Topic | 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". | Req |
| VSTEST | Vital Signs Test Name | Char | (VSTEST) | Synonym Qualifier | 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". | Req |
| VSCAT | Category for Vital Signs | Char | Grouping Qualifier | Used to define a category of related records. | Perm | |
| VSSCAT | Subcategory for Vital Signs | Char | Grouping Qualifier | A further categorization of a measurement or examination. | Perm | |
| VSPOS | Vital Signs Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". | Perm |
| VSORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the vital signs measurement as originally received or collected. | Exp | |
| VSORRESU | Original Units | Char | (VSRESU) | Variable Qualifier | Original units in which the data were collected. The unit for VSORRES. Examples: "in", "LB", "beats/min". | Exp |
| VSSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | 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". | Exp | |
| VSSTRESN | 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 VSSTRESC. VSSTRESN should store all numeric test results or findings. | Exp | |
| VSSTRESU | Standard Units | Char | (VSRESU) | Variable Qualifier | Standardized unit used for VSSTRESC and VSSTRESN. | Exp |
| VSSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a vital sign measurement was not done. Should be null if a result exists in VSORRES. | Perm |
| VSREASND | Reason Not Performed | Char | Record Qualifier | Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with VSSTAT when value is "NOT DONE". | Perm | |
| VSLOC | Location of Vital Signs Measurement | Char | (LOC) | Record Qualifier | Location relevant to the collection of vital signs measurement. Example: "ARM" for blood pressure. | Perm |
| VSLAT | Laterality | Char | (LAT) | Result Qualifier | Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". | Perm |
| VSLOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null. | Exp |
| VSTOX | Toxicity | Char | Variable Qualifier | Description of toxicity quantified by VSTOXGR. | Perm | |
| VSTOXGR | Standard Toxicity Grade | Char | Record Qualifier | 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"). | Perm | |
VSCLSIG | Clinically Significant, Collected | Char | (NY) | Record Qualifier | Used to indicate whether a collected observation is clinically significant based on judgment. | Perm |
| VISITNUM | Visit Number | Num | Timing |
| Exp | |
| VISIT | Visit Name | Char | Timing | Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY. | Perm | |
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | 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 | Epoch associated with the start date/time at which the assessment was made. | Perm |
| VSDTC | Date/Time of Measurements | Char | ISO 8601 datetime or interval | Timing | Date and time of the vital signs assessment represented in ISO 8601 character format. | Exp |
| VSDY | Study Day of Vital Signs | Num | Timing | Study day of vital signs measurements, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | |
| VSTPT | Planned Time Point Name | Char | Timing | 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". | Perm | |
| VSTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of VSTPT to aid in sorting. | Perm | |
| VSELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | 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. | Perm |
| VSTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by VSELTM, VSTPTNUM, and VSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". | Perm | |
| VSRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time of the reference time point, VSTPTREF. | Perm |
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