| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
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 |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Perhaps pre-printed on the
CRF as an explicit line identifier or defined in the sponsor's
operational database. |
Perm |
| VSTESTCD |
Vital Signs Test Short Name |
Char |
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 |
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 |
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 |
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 |
Variable Qualifier |
Standardized unit used for VSSTRESC and VSSTRESN. |
Exp |
| VSSTAT |
Completion Status |
Char |
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" or "SUBJECT REFUSED". Used in
conjunction with VSSTAT when value is "NOT DONE". |
Perm |
| VSLOC |
Location of Vital Signs Measurement |
Char |
Record Qualifier |
Location relevant to the collection of Vital Signs
measurement. Example: "ARM" for blood pressure. |
Perm |
| VSLAT |
Laterality |
Char |
Result Qualifier |
Qualifier for anatomical location or specimen further
detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". |
Perm |
| VSLOBXFL |
Last Observation Before Exposure Flag |
Char |
Record Qualifier |
Operationally-derived indicator used to identify the last
non-missing value prior to RFXSTDTC. Should be "Y" or null. |
Exp |
| VSBLFL |
Baseline Flag |
Char |
Record Qualifier |
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. |
Perm |
| VSDRVFL |
Derived Flag |
Char |
Record Qualifier |
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. |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
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 |
Timing |
Epoch associated with the start date/time at which the
assessment was made. |
Perm |
| VSDTC |
Date/Time of Measurements |
Char |
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
sponsor-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, such as 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 |
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 |
Perm |
| |
|
|
|
an ISO 8601 Duration. 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. |
|
| 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 |
Timing |
Date/time of the reference time point, VSTPTREF. |
Perm |