SEND VS specification

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 datetime or interval

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 datetime or interval

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 duration 

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 datetime or interval

Timing

Date/Time of the reference time point, VSTPTREF.

Perm