Final call before we close subscription!
Subscription to input data and programs (including SAS and R) for all the lessons is now offered at 7,500 INR for a few days.
Click here for more details.
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. Perhaps pre-printed 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"). 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 or 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 VSBLFL Baseline Flag Char C66742 Record Qualifier Exp Indicator used to identify a baseline value. The value should be "Y" or null.
22 VS VSDRVFL Derived Flag Char C66742 Record Qualifier Perm Used to indicate a derived record. The value should be Y or null. Records which represent the average of other records or which 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.
23 VS VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
24 VS VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
25 VS VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
26 VS VSDTC Date/Time of Measurements Char ISO 8601 Timing Exp
27 VS VSDY Study Day of Vital Signs Num Timing Perm 1. Study day of vital signs measurements, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.
28 VS VSTPT Planned Time Point Name Char Timing Perm 1. Text Description of time when measurement should be taken. 2. 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
29 VS VSTPTNUM Planned Time Point Number Num Timing Perm Numerical version of VSTPT to aid in sorting.
30 VS VSELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 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, or "PT8H" to represent the period of 8 hours after the reference point indicated by VSTPTREF.
31 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.
32 VS VSRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time of the reference time point, LBTPTREF.