Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 NV 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 NV 2 DOMAIN Domain Abbreviation Char NV Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 NV 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 NV 4 FOCID Focus of Study-Specific Interest Char Identifier Identification of a focus of study-specific interest on or within a subject or specimen as called out in the protocol for which a measurement, test, or examination was performed, such as a drug application site, e.g., "Injection site 1", "Biopsy site 1", "Treated site 1", or a more specific focus, e.g., "OD" (right eye) or "Upper left quadrant of the back". The value in this variable should have inherent semantic meaning. Perm
SDTMIG 3.3 NV 5 NVSEQ Sequence Number Num Identifier Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 NV 6 NVGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 NV 7 NVREFID Reference ID Char Identifier Internal or external procedure identifier. Perm
SDTMIG 3.3 NV 8 NVSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the procedure or test page. Perm
SDTMIG 3.3 NV 9 NVLNKID Link ID Char Identifier Identifier used to link a procedure to the assessment results over the course of the study. Perm
SDTMIG 3.3 NV 10 NVLNKGRP 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 NV 11 NVTESTCD Short Name of Nervous System Test Char (NVTESTCD) Topic Short name of the measurement, test, or examination described in NVTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in NVTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). NVTESTCD cannot contain characters other than letters, numbers, or underscores. Example: "SUVR", "N75LAT", "P100LAT","N145LAT", etc. Req
SDTMIG 3.3 NV 12 NVTEST Name of Nervous System Test Char (NVTEST) Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or finding. The value in NVTEST cannot be longer than 40 characters. Example: "Standard Uptake Value Ratio", "N75 Latency", "P100 Latency", "N145 Latency", etc. Req
SDTMIG 3.3 NV 13 NVCAT Category for Nervous System Test Char Grouping Qualifier Used to define a category of topic-variable values. Example: "VISUAL EVOKED POTENTIAL". Perm
SDTMIG 3.3 NV 14 NVSCAT Subcategory for Nervous System Test Char Grouping Qualifier Used to define a further categorization of NVCAT values. Perm
SDTMIG 3.3 NV 15 NVORRES Result or Finding in Original Units Char Result Qualifier Result of the procedure measurement or finding as originally received or collected. Exp
SDTMIG 3.3 NV 16 NVORRESU Original Units Char (UNIT) Variable Qualifier Original units in which the data were collected. The unit for NVORRES. Perm
SDTMIG 3.3 NV 17 NVSTRESC Character Result/Finding in Std Format Char Result Qualifier Contains the result value for all findings, copied or derived from NVORRES in a standard format or standard units. NVSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in NVSTRESN. Exp
SDTMIG 3.3 NV 18 NVSTRESN 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 NVSTRESC. NVSTRESN should store all numeric test results or findings. Perm
SDTMIG 3.3 NV 19 NVSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized unit used for NVSTRESC or NVSTRESN. Perm
SDTMIG 3.3 NV 20 NVSTAT Completion Status Char (ND) Record Qualifier Used to indicate a test was not done, or a measurement was not taken. Should be null if a result exists in NVORRES. Perm
SDTMIG 3.3 NV 21 NVREASND 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 NVSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 NV 22 NVLOC Location Used for the Measurement Char (LOC) Record Qualifier Anatomical location of the subject relevant to the collection of the measurement. Examples: "BRAIN", "EYE", "PRECUNEUS", "CINGULATE CORTEX", etc. Perm
SDTMIG 3.3 NV 23 NVLAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". Perm
SDTMIG 3.3 NV 24 NVDIR Directionality Char (DIR) Variable Qualifier Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". Perm
SDTMIG 3.3 NV 25 NVMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. Examples: "EEG", "PET/CT SCAN ", "FDGPET", etc. Perm
SDTMIG 3.3 NV 26 NVLOBXFL 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. Perm
SDTMIG 3.3 NV 27 NVBLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. Should be "Y" or null. Note that NVBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 NV 28 NVDRVFL 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 NV 29 NVEVAL 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 NV 30 NVEVALID Evaluator Identifier Char (MEDEVAL) Variable Qualifier Used to distinguish multiple evaluators with the same role recorded in NVEVAL. Examples: "RADIOLOGIST 1" or "RADIOLOGIST 2". Perm
SDTMIG 3.3 NV 31 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 NV 32 VISIT Visit Name Char Timing 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 NV 33 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 NV 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 NV 35 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the assessment was made. Perm
SDTMIG 3.3 NV 36 NVDTC Date/Time of Collection Char ISO 8601 Timing Date of procedure or test. Exp
SDTMIG 3.3 NV 37 NVDY Study Day of Visit/Collection/Exam Num Timing 1. Study day of the procedure or test, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Perm
SDTMIG 3.3 NV 38 NVTPT Planned Time Point Name Char Timing 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 NVTPTNUM and NVTPTREF. Examples: "Start", "5 min post". Perm
SDTMIG 3.3 NV 39 NVTPTNUM Planned Time Point Number Num Timing Numerical version of NVTPT to aid in sorting. Perm
SDTMIG 3.3 NV 40 NVELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned elapsed time (in ISO 8601) relative to a fixed time point reference (NVTPTREF). 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 NVTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by NVTPTREF. Perm
SDTMIG 3.3 NV 41 NVTPTREF Time Point Reference Char Timing Name of the fixed reference point referred to by NVELTM, NVTPTNUM, and NVTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". Perm
SDTMIG 3.3 NV 42 NVRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 character format. Perm