SDTM.NV

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	NV	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	NV	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	NV	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	NV	FOCID	Focus of Study-Specific Interest	Char		Identifier	Perm	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.
5	NV	NVSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
6	NV	NVGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
7	NV	NVREFID	Reference ID	Char		Identifier	Perm	Internal or external procedure identifier.
8	NV	NVSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	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.
9	NV	NVLNKID	Link ID	Char		Identifier	Perm	Identifier used to link a procedure to the assessment results over the course of the study.
10	NV	NVLNKGRP	Link Group	Char		Identifier	Perm	Identifier used to link related records across domains. This will usually be a many-to-one relationship.
11	NV	NVTESTCD	Short Name of Nervous System Test	Char	C116104	Topic	Req	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.
12	NV	NVTEST	Name of Nervous System Test	Char	C116103	Synonym Qualifier	Req	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.
13	NV	NVCAT	Category for Nervous System Test	Char		Grouping Qualifier	Perm	Used to define a category of topic-variable values. Example: "VISUAL EVOKED POTENTIAL".
14	NV	NVSCAT	Subcategory for Nervous System Test	Char		Grouping Qualifier	Perm	Used to define a further categorization of NVCAT values.
15	NV	NVORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the procedure measurement or finding as originally received or collected.
16	NV	NVORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Original units in which the data were collected. The unit for NVORRES.
17	NV	NVSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	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.
18	NV	NVSTRESN	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 NVSTRESC. NVSTRESN should store all numeric test results or findings.
19	NV	NVSTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized unit used for NVSTRESC or NVSTRESN.
20	NV	NVSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate a test was not done, or a measurement was not taken. Should be null if a result exists in NVORRES.
21	NV	NVREASND	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 NVSTAT when value is "NOT DONE".
22	NV	NVLOC	Location Used for the Measurement	Char	C74456	Record Qualifier	Perm	Anatomical location of the subject relevant to the collection of the measurement. Examples: "BRAIN", "EYE", "PRECUNEUS", "CINGULATE CORTEX", etc.
23	NV	NVLAT	Laterality	Char	C99073	Variable Qualifier	Perm	Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
24	NV	NVDIR	Directionality	Char	C99074	Variable Qualifier	Perm	Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
25	NV	NVMETHOD	Method of Test or Examination	Char	C85492	Record Qualifier	Perm	Method of the test or examination. Examples: "EEG", "PET/CT SCAN ", "FDGPET", etc.
26	NV	NVLOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Perm	Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
27	NV	NVBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	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.
28	NV	NVDRVFL	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	NV	NVEVAL	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	NV	NVEVALID	Evaluator Identifier	Char	C96777	Variable Qualifier	Perm	Used to distinguish multiple evaluators with the same role recorded in NVEVAL. Examples: "RADIOLOGIST 1" or "RADIOLOGIST 2".
31	NV	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
32	NV	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
33	NV	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
34	NV	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	NV	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the date/time at which the assessment was made.
36	NV	NVDTC	Date/Time of Collection	Char	ISO 8601	Timing	Exp	Date of procedure or test.
37	NV	NVDY	Study Day of Visit/Collection/Exam	Num		Timing	Perm	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.
38	NV	NVTPT	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 NVTPTNUM and NVTPTREF. Examples: "Start", "5 min post".
39	NV	NVTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of NVTPT to aid in sorting.
40	NV	NVELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601	Timing	Perm	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.
41	NV	NVTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point referred to by NVELTM, NVTPTNUM, and NVTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
42	NV	NVRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601	Timing	Perm	Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 character format.