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 Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm |
VSSPID | Sponsor-Defined Identifier | Char |
| Identifier | Sponsor-defined reference identifier | Perm |
VSTESTCD | Vital Signs Test Short Name | Char | (SVSTSTCD) | Topic | Short name of the measurement 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. | Req |
VSTEST | Vital Signs Test Name | Char | (SVSTST) | Synonym Qualifier | Long name for VSTESTCD. The value in VSTEST cannot be longer than 40 characters. | Req |
VSCAT | Category for Vital Signs | Char |
| Grouping Qualifier | Used to define a category of the vital signs measurement performed. | Perm |
VSSCAT | Subcategory for Vital Signs | Char |
| Grouping Qualifier | A further categorization of the vital signs measurement performed. | Perm |
VSPOS | Vital Signs Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during the measurement. If the subject is restrained, populate with the position (example SITTING or STANDING). | Perm |
VSORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the vital signs measurement as originally received or collected. | Exp |
VSORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp |
VSSTRESC | Standardized Result in Character 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 in character format; if results are numeric, they should also be submited in numeric format in VSSTRESN. | Exp |
VSSTRESN | Standardized Result in Numeric Format | Num |
| Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of VSSTRESC. VSSTRESN should store all numeric test results or findings. | Exp |
VSSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for VSSTRESC and VSSTRESN. | Exp |
VSSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in VSORRES. | Perm |
VSREASND | Reason Not Done | Char |
| Record Qualifier | Describes why VSSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm |
VSLOC | Location of Vital Signs Measurement | Char |
| Record Qualifier | Location relevant to the collection of the vital signs measurement. Example: RECTAL for Temperature. | Perm |
VSCSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Perm |
VSBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Exp |
VSDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm |
VSEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm |
VSREASEX | Reason for Exclusion | Char |
| Record Qualifier | The reason the result should be excluded from all calculations. Used only when VSEXCLFL is Y. | Perm |
VSUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm |
VISITDY | Planned Study Day of Collection | Num |
| Timing | Planned day of the vital signs measurement. Should be an integer. | Perm |
VSDTC | Date/Time of Measurement | Char | ISO 8601 | Timing | Date/Time of the vital sign measurement, in ISO 8601 format. For indicating measurement over a period, DTC should be populated with the start date/time of collection. | Exp |
VSENDTC | End Date/Time of Measurement | Char | ISO 8601 | Timing | Date/Time of the end of the vital sign measurement, in ISO 8601 format. Should be populated for continuous period only. | Perm |
VSDY | Study Day of Vital Signs Measurement | Num |
| Timing | Study day of vital signs measurements, in integer days. For indicating measurement over a continuous period, VSDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
VSENDY | Study Day of End of Measurement | Num |
| Timing | Study day of the end of the vital signs measurement, in integer days. Can be populated when VSDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
VSNOMDY | Nominal Study Day for Tabulations | Num |
| Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp |
VSNOMLBL | Label for Nominal Study Day | Char |
| Timing | A label for a given value of VSNOMDY as presented in the study report. Examples: Pre-Treatment, Week 4, Day 28. | Perm |
VSTPT | Planned Time Point Name | Char |
| Timing | Text description of time when the vital signs measurement should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See VSTPTNUM and VSTPTREF. Examples: Predose, 1 Hour Postdose. | 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 | Timing | Planned elapsed time (in ISO 8601 format) 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 a duration in ISO 8601 format. Examples: '-PT15M' to represent the period of 15 minutes prior to the reference point indicated by VSTPTREF or '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, if used for VSTPTNUM, and VSTPT. It is recommended that VSTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: DAY 1 DOSE, DAY 1 MEAL. | Perm |
VSRFTDTC | Date/Time of Time Point Reference | Char | ISO 8601 | Timing | Date/Time of the reference time point, VSTPTREF. | Perm |