Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 CV 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 CV 2 DOMAIN Domain Abbreviation Char CV Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 CV 3 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
SDTMIG 3.3 CV 4 CVSEQ Sequence Number Num Identifier 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. Req
SDTMIG 3.3 CV 5 CVGRPID Group ID Char Identifier Optional group identifier, used to link together a block of related records within a subject in a domain. Perm
SDTMIG 3.3 CV 6 CVREFID Reference ID Char Identifier Optional internal or external identifier. Perm
SDTMIG 3.3 CV 7 CVSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. Example: "preprinted line identifier on a Case Report Form". Perm
SDTMIG 3.3 CV 8 CVLNKID Link ID Char Identifier Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. Perm
SDTMIG 3.3 CV 9 CVLNKGRP Link Group Char Identifier Identifier used to link related records across domains. This will usually be a many-to-one relationship. Perm
SDTMIG 3.3 CV 10 CVTESTCD Short Name of Cardiovascular Test Char (CVTESTCD) Topic 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. Req
SDTMIG 3.3 CV 11 CVTEST Name of Cardiovascular Test Char (CVTEST) Synonym Qualifier Long name For CVTESTCD. The value in CVTEST cannot be longer than 40 characters. Req
SDTMIG 3.3 CV 12 CVCAT Category for Cardiovascular Test Char Grouping Qualifier Used to define a category of topic-variable values. Perm
SDTMIG 3.3 CV 13 CVSCAT Subcategory for Cardiovascular Test Char Grouping Qualifier Used to define a further categorization of CVCAT values. Perm
SDTMIG 3.3 CV 14 CVPOS Position of Subject During Observation Char (POSITION) Record Qualifier Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". Perm
SDTMIG 3.3 CV 15 CVORRES Result or Finding in Original Units Char Result Qualifier Result of the measurement or finding as originally received or collected. Exp
SDTMIG 3.3 CV 16 CVORRESU Original Units Char (UNIT) Variable Qualifier Original units in which the data were collected. Unit for CVORRES. Perm
SDTMIG 3.3 CV 17 CVSTRESC Character Result/Finding in Std Format Char Result Qualifier 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". Exp
SDTMIG 3.3 CV 18 CVSTRESN 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 CVSTRESC. CVSTRESN should store all numeric test results or findings. Perm
SDTMIG 3.3 CV 19 CVSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for CVSTRESC and CVSTRESN. Perm
SDTMIG 3.3 CV 20 CVSTAT Completion Status Char (ND) Record Qualifier 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". Perm
SDTMIG 3.3 CV 21 CVREASND Reason Not Done Char Record Qualifier 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". Perm
SDTMIG 3.3 CV 22 CVLOC Location Used for the Measurement Char (LOC) Record Qualifier Anatomical location of the subject relevant to the collection of the measurement. Example: "HEART", "LEFT VENTRICLE". Perm
SDTMIG 3.3 CV 23 CVLAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL", "UNILATERAL". Perm
SDTMIG 3.3 CV 24 CVDIR Directionality Char (DIR) Variable Qualifier Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". Perm
SDTMIG 3.3 CV 25 CVMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method used to create the result. Perm
SDTMIG 3.3 CV 26 CVLOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. Exp
SDTMIG 3.3 CV 27 CVBLFL Baseline Flag Char (NY) Record Qualifier 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. Perm
SDTMIG 3.3 CV 28 CVDRVFL Derived Flag Char (NY) Record Qualifier 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. Perm
SDTMIG 3.3 CV 29 CVEVAL Evaluator Char (EVAL) Record Qualifier 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". Perm
SDTMIG 3.3 CV 30 CVEVALID Evaluator Identifier Char (MEDEVAL) Variable Qualifier Used to distinguish multiple evaluators with the same role recorded in CVEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". Perm
SDTMIG 3.3 CV 31 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 CV 32 VISIT Visit Name Char Timing Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 CV 33 VISITDY Planned Study Day of Visit Num Timing Planned study day of VISIT. Should be an integer. Perm
SDTMIG 3.3 CV 34 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm for the element in which the assessment was made. Perm
SDTMIG 3.3 CV 35 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the assessment was made. Perm
SDTMIG 3.3 CV 36 CVDTC Date/Time of Test Char ISO 8601 Timing Collection date and time of an observation. Exp
SDTMIG 3.3 CV 37 CVDY Study Day of Visit/Collection/Exam Num Timing Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 CV 38 CVTPT Planned Time Point Name Char Timing 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. Perm
SDTMIG 3.3 CV 39 CVTPTNUM Planned Time Point Number Num Timing Numeric version of planned time point used in sorting. Perm
SDTMIG 3.3 CV 40 CVELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing 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. Perm
SDTMIG 3.3 CV 41 CVTPTREF Time Point Reference Char Timing Description of the fixed reference point referred to by CVELTM, CVTPTNUM, and CVTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". Perm
SDTMIG 3.3 CV 42 CVRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by CVTPTREF. Perm