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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 CV STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 CV DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 CV 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 CV CVSEQ Sequence Number Num Identifier Req Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number (including decimals) and does not have to start at 1.
5 CV CVGRPID Group ID Char Identifier Perm Optional group identifier, used to link together a block of related records within a subject in a domain.
6 CV CVREFID Reference ID Char Identifier Perm Optional internal or external identifier.
7 CV CVSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier. Example: "preprinted line identifier on a Case Report Form".
8 CV CVLNKID Link ID Char Identifier Perm Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
9 CV CVLNKGRP Link Group Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
10 CV CVTESTCD Short Name of Cardiovascular Test Char C101847 Topic Req Short name of the measurement, test, or examination described in CVTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CVTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). CVTESTCD cannot contain characters other than letters, numbers, or underscores.
11 CV CVTEST Name of Cardiovascular Test Char C101846 Synonym Qualifier Req Long name For CVTESTCD. The value in CVTEST cannot be longer than 40 characters.
12 CV CVCAT Category for Cardiovascular Test Char Grouping Qualifier Perm Used to define a category of topic-variable values.
13 CV CVSCAT Subcategory for Cardiovascular Test Char Grouping Qualifier Perm Used to define a further categorization of CVCAT values.
14 CV CVPOS Position of Subject During Observation Char C71148 Record Qualifier Perm Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".
15 CV CVORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected.
16 CV CVORRESU Original Units Char C71620 Variable Qualifier Perm Original units in which the data were collected. Unit for CVORRES.
17 CV CVSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from CVORRES in a standard format or in standard units. CVSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in CVSTRESN. For example, if various tests have results "NONE", "NEG", and "NEGATIVE" in CVORRES and these results effectively have the same meaning, they could be represented in standard format in CVSTRESC as "NEGATIVE".
18 CV CVSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Perm Used for continuous or numeric results or findings in standard format; copied in numeric format from CVSTRESC. CVSTRESN should store all numeric test results or findings.
19 CV CVSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized units used for CVSTRESC and CVSTRESN.
20 CV CVSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of "NOT DONE".
21 CV CVREASND Reason Not Done Char Record Qualifier Perm Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT" or "SUBJECT REFUSED". Used in conjunction with CVSTAT when value is "NOT DONE".
22 CV CVLOC Location Used for the Measurement Char C74456 Record Qualifier Perm Anatomical location of the subject relevant to the collection of the measurement. Example: "HEART", "LEFT VENTRICLE".
23 CV CVLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL", "UNILATERAL".
24 CV CVDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
25 CV CVMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method used to create the result.
26 CV CVLOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Exp Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
27 CV CVBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. Should be "Y" or null. Note that CVBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.
28 CV CVDRVFL Derived Flag Char C66742 Record Qualifier Perm Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be "Y" or null.
29 CV CVEVAL Evaluator Char C78735 Record Qualifier Perm Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: "ADJUDICATION COMMITTEE", " INDEPENDENT ASSESSOR", "RADIOLOGIST".
30 CV CVEVALID Evaluator Identifier Char C96777 Variable Qualifier Perm Used to distinguish multiple evaluators with the same role recorded in CVEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2".
31 CV VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
32 CV VISIT Visit Name Char Timing Perm Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
33 CV VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of VISIT. Should be an integer.
34 CV TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm for the element in which the assessment was made.
35 CV EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the assessment was made.
36 CV CVDTC Date/Time of Test Char ISO 8601 Timing Exp Collection date and time of an observation.
37 CV CVDY Study Day of Visit/Collection/Exam Num Timing Perm Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
38 CV CVTPT Planned Time Point Name Char Timing Perm Text description of time when a measurement or observation should be taken, as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See CVTPTNUM and CVTPTREF.
39 CV CVTPTNUM Planned Time Point Number Num Timing Perm Numeric version of planned time point used in sorting.
40 CV CVELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned Elapsed time relative to a planned fixed reference (CVTPTREF) such as "PREVIOUS DOSE" or "PREVIOUS MEAL". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.
41 CV CVTPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by CVELTM, CVTPTNUM, and CVTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
42 CV CVRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time for a fixed reference time point defined by CVTPTREF.