CDISC SDTM Implementation Guide (Version 3.

3 Draft)
Note: Section 6.3 - NV Domain
underwent public review as part of
1 6 Domain Models Based on the General SDTMIG 3.3 Batch 2 toward the
end of 2014. The date in the footer
of this copy reflects the most recent
2 Observation Class updates made since then.

3 6.3 Findings

T
4 Nervous System Findings (NV)

5 NV - Description/Overview for the Nervous System Findings Domain Model

AF
6 The Nervous System Findings physiology domain represents tests results from neurological examinations or procedures. Information about the examination or
7 procedure may or may not be collected.

8 NV - Specification for the Nervous System Findings Domain Model

9 nv.xpt, Nervous System Findings — Findings, Version 3.3. One record per finding per location per time point per visit per subject, Tabulation
Controlled
Variable
Variable Label Type Terms, Codelist Role CDISC Notes Core
Name
or Format
STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
DOMAIN Domain Char NV Identifier Two-character abbreviation for the domain. Req
DR
Abbreviation
USUBJID Unique Subject Char Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions Req
Identifier involving the product.
NVSEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid Req
number.
NVGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
NVREFID Reference ID Char Identifier Internal or external procedure identifier. Perm
NVSPID Sponsor-Defined Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or Perm
Identifier defined in the sponsor's operational database. Example: Line number from the procedure or test page.
NVLNKID Link ID Char Identifier Identifier used to link a procedure to the assessment results over the course of the study. Perm
NVTESTCD Test or Examination Char (NVTESTCD) Topic Short name of the measurement, test, or examination described in NVTEST. It can be used as a Req
Short Name 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”).
NVTESTCD cannot contain characters other than letters, numbers, or underscores. Example: SUVR.
N75LAT, P100LAT, N145LAT, etc.

© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved NV - Page 1
Draft January 20, 2015
CDISC SDTM Implementation Guide (Version 3.3 Draft)

Controlled
Variable
Variable Label Type Terms, Codelist Role CDISC Notes Core
Name
or Format
NVTEST Test or Examination Char (NVTEST) Synonym Verbatim name of the test or examination used to obtain the measurement or finding. The value in Req
Name Qualifier NVTEST cannot be longer than 40 characters. Example: Standard Uptake Value Ratio, N75 Latency,
P100 Latency, N145 Latency, etc.

NVCAT Category for Test Char * Grouping Used to categorize observations across subjects. Perm
Qualifier
NVSCAT Subcategory for Char * Grouping A further categorization. Perm

T
Test Qualifier
NVORRES Result or Finding in Char Result Result of the procedure measurement or finding as originally received or collected. Exp
Original Units Qualifier

AF
NVORRESU Original Units Char (UNIT) Variable Original units in which the data were collected. The unit for NVORRES. Perm
Qualifier
NVSTRESC Character Char Result Contains the result value for all findings, copied or derived from NVORRES in a standard format or Exp
Result/Finding in Qualifier standard units. NVSTRESC should store all results or findings in character format; if results are
Std Format numeric, they should also be stored in numeric format in NVSTRESN.
NVSTRESN Numeric Num Result Used for continuous or numeric results or findings in standard format; copied in numeric format from Perm
Result/Finding in Qualifier NVSTRESC. NVSTRESN should store all numeric test results or findings.
Standard Units
NVSTRESU Standard Units Char (UNIT) Variable Standardized unit used for NVSTRESC or NVSTRESN. Perm
Qualifier
NVSTAT Completion Status Char (ND) Record Used to indicate a test was not done, or a measurement was not taken. Should be null if a result exists Perm
Qualifier in NVORRES.
DR
NVREASND Reason Test Not Char Record Describes why a measurement or test was not performed. Examples: BROKEN EQUIPMENT or Perm
Performed Qualifier SUBJECT REFUSED. Used in conjunction with NVSTAT when value is NOT DONE.
NVLOC Location Used for Char (LOC) Record Anatomical location of the subject relevant to the collection of the measurement. Examples: BRAIN, Perm
Measurement Qualifier EYE, PRECUNEUS, CINGULATE CORTEX, etc.
NVLAT Laterality Char (LAT) Variable Qualifier for anatomical location or specimen further detailing laterality. Examples: RIGHT, LEFT, Perm
Qualifier BILATERAL
NVDIR Directionality Char (DIR) Variable Qualifier for anatomical location or specimen further detailing directionality. Examples: Perm
Qualifier ANTERIOR, LOWER, PROXIMAL
NVMETHOD Method of Test or Char (METHOD) Record Method of the test or examination. Examples: EEG, PET/CT SCAN , FDGPET, etc. Perm
Examination Qualifier
NVBLFL Baseline Flag Char (NY) Record Indicator used to identify a baseline value. The value should be “Y” or null. Exp
Qualifier
NVDRVFL Derived Flag Char (NY) Record Used to indicate a derived record (e.g., a record that represents the average of other records such as a Perm
Qualifier computed baseline). Should be Y or null.

© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved NV - Page 2
Draft January 20, 2015
 CDISC SDTM Implementation Guide (Version 3.3 Draft)

Controlled
Variable
Variable Label Type Terms, Codelist Role CDISC Notes Core
Name
or Format
NVEVAL Evaluator Char * Record Role of the person who provided the evaluation. Used only for results that are subjective (e.g., Perm
Qualifier assigned by a person or a group). Examples: ADJUDICATION COMMITTEE, INDEPENDENT
ASSESSOR, RADIOLOGIST.
VISITNUM Visit Number Num Timing 1. Clinical encounter number. Exp
2. Numeric version of VISIT, used for sorting.
VISIT Visit Name Char Timing 1. Protocol-defined description of clinical encounter. Perm
2. May be used in addition to VISITNUM and/or VISITDY.

T
VISITDY Planned Study Day Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
of Visit
NVDTC Date/Time of Test Char ISO 8601 Timing Date of procedure or test. Exp
NVDY Study Day of Test Num Timing 1. Study day of the procedure or test, measured as integer days. Perm
2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in

AF
Demographics.
NVTPT Planned Time Point Char Timing 1. Text Description of time when measurement should be taken. Perm
Name 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.
NVTPTNUM Planned Time Point Num Timing Numerical version of NVTPT to aid in sorting. Perm
Number
NVELTM Planned Elapsed Char ISO 8601 Timing Planned elapsed time (in ISO 8601) relative to a fixed time point reference (NVTPTREF). Not a Perm
Time from Time clock time or a date time variable. Represented as an ISO 8601 duration. Examples: “-PT15M” to
Point Ref 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.
NVTPTREF Time Point Char Timing Name of the fixed reference point referred to by NVELTM, NVTPTNUM, and NVTPT. Examples: Perm
Reference PREVIOUS DOSE, PREVIOUS MEAL.
NVRFTDTC Date/Time of Char ISO 8601 Timing Date/time of the reference time point, NVTPTREF. Perm
DR
Reference Time
Point
10 * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI codelist code value)

11 NV - Assumptions for the Nervous System Findings Domain Model

12 1. Nervous System Physiology Domain Definition: CRF or eDT Findings Data received as a result of tests from a neurological examination or procedure.
13 These are active processes, but information about the examination or a procedure may or may not be collected.
14 2. Neurological Examination examples that may have results represented in the NV domain: mental status, cranial nerves, motor system, sensory system,
15 the deep tendon reflexes, coordination and the cerebellum, gait
16 3. Neurological Procedures: The following are examples of procedures that could produce NV results: CT, MRI, PET, EEG, EMG, etc.
17 4. Additional Findings Qualifiers
18 a. Other additional qualifiers from the SDTM Findings Class may be added to this domain
19 b. The following qualifiers would not generally be used in NV: --MODIFY, --BODSYS,--LOINC, --TOX, --TOXGR.

© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved NV - Page 3
Draft January 20, 2015
 CDISC SDTM Implementation Guide (Version 3.3 Draft)

20 NV - Examples for the Nervous System Findings Domain Model

21 Example 1
22 This PET and PET/CT imaging data example demonstrated the various data, including the PR, AG and NV domains and their relationship in this imaging
23 process.
24
25 The following example demonstrates the SDTM-based modeling of the nervous system information collected and generated (as described above) from separate
26 PET or PET/CT procedures. The TAUG-MS contains the details of the PR and AG domain data.
27

T
28 Standard Uptake Value Ratio (SUVR) is a measure of nervous system activity. The data below shows measures for standard uptake value ratios taken from three
29 PET scans. SPDEVID shows the scanner used. NVLNKID can be used to link back to the imaging procedure record in the PR domain (PRLNKID), as well as to
30 the tracer administration record in the AG domain (AGLNKID). AGLNKID would be used to determine which tracer uptake is being measured (SUVR), and
31 therefore to which biomarker the findings pertain. NVDTC corresponds to the date of the PET or PET/CT procedure from which these results were obtained.
32

AF
33 Rows 1-2: Show the Standard Uptake Value Ratio (SUVR) findings based on a PET/CT scan for Subject AD01-101.
34 Rows 3-4: Show the SUVR findings based on a PET/CT scan for subject AD01-102.
35 Rows 5-6: Show the SUVR findings based on an FDG-PET scan for subject AD AD01-103.
36
37 nv.xpt
Row STUDYID DOMAIN USUBJID SPDEVID NVSEQ NVREFID NVLNKID NVTESTCD NVTEST NVORRES NVORRESU
1 ABC123 NV AD01-101 22 1 1236 03 SUVR Standard Uptake Value Ratio .95 RATIO
2 ABC123 NV AD01-101 22 2 1236 03 SUVR Standard Uptake Value Ratio 1.17 RATIO
3 ABC123 NV AD01-102 22 1 1237 04 SUVR Standard Uptake Value Ratio 1.21 RATIO
4 ABC123 NV AD01-102 22 2 1237 04 SUVR Standard Uptake Value Ratio 1.78 RATIO
5 ABC123 NV AD01-103 44 1 1238 05 SUVR Standard Uptake Value Ratio 1.52 RATIO
6 ABC123 NV AD01-103 44 2 1238 05 SUVR Standard Uptake Value Ratio 1.63 RATIO
38
DR
Row NVSTRESC NVSTRESN NVSTRRESU NVLOC NVDIR NVMETHOD NVDTC
1 (cont) .95 .95 RATIO PRECUNEUS PET/CT SCAN 2012-05-22
2 (cont) 1.17 1.17 RATIO CINGULATE CORTEX POSTERIOR PET/CT SCAN 2012-05-22
3 (cont) 1.21 1.21 RATIO PRECUNEUS PET/CT SCAN 2012-05-22
4 (cont) 1.78 1.78 RATIO CINGULATE CORTEX POSTERIOR PET/CT SCAN 2012-05-22
5 (cont) 1.52 1.52 RATIO PRECUNEUS FDGPET 2012-05-22
6 (cont) 1.63 1.63 RATIO CINGULATE CORTEX POSTERIOR FDGPET 2012-05-22
39
40 A Supplemental Qualifiers dataset is used for additional data elements that are not part of the NV domain.
41
42 Rows 1-6: Shows the reference region used for the SUVR tests shown in the NV domain.
43
44 suppnv.xpt
Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL
1 ABC123 NV AD01-101 NVSEQ 1 REFREG Reference Region CEREBELLUM
2 ABC123 NV AD01-101 NVSEQ 2 REFREG Reference Region CEREBELLUM

© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved NV - Page 4
Draft January 20, 2015
 CDISC SDTM Implementation Guide (Version 3.3 Draft)

Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL

3 ABC123 NV AD01-102 NVSEQ 1 REFREG Reference Region CEREBELLUM
4 ABC123 NV AD01-102 NVSEQ 2 REFREG Reference Region CEREBELLUM
5 ABC123 NV AD01-103 NVSEQ 1 REFREG Reference Region PONS
6 ABC123 NV AD01-103 NVSEQ 2 REFREG Reference Region PONS
45
46 The RELREC table below displays the dataset relationship on how a procedure is linked to multiple Nervous System (NV) domain records and how an individual
47 procedure Agent administration record related to a scan is linked to multiple Nervous System (NV) domain records. For simplicity of review, only examples for
48 USUBJID=AD01-101are shown. Note that each of the three relationships identified by RELID would need to be implemented for subjects AD01-102 and AD01-
49 103 using unique RELID values for each.

T
50
51 Rows 1-2: Show how to relate records between the procedure and the result. A unique procedure is linked via the PRLINKID value to the same value in the
52 NV domain’s NVLNKID variable to obtain the multiple NV results.
53 Rows 3-4: Link the radiolabeled tracer used to obtain the SUVR results. Multiple SUVR values may result from a single tracer administration, distinguished
54 by brain region (NVLOC). A single AG administration record with the AGLNKID value is linked to the same value in the NVLNKID variable to

AF
55 obtain all of the related NV results.
56 Rows 5-6: Link the results to the individual scan as defined by the properties/settings of the scanner used. Multiple NVTEST records with the NVREFID
57 value are linked to the same value in the DUREFID variable to obtain all of the related DU results. This relationship is unusual and challenging to
58 manage in a join/merge and only represents the concept of this relationship. To uniquely identify all the DUTEST values related to an individual
59 NVTEST, select an individual NVREFID to join/merge with the DUREFID to revise this to a one-to-many relationship to obtain all related
60 DUTEST results.
61
62 relrec.xpt
Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
1 ABC123 PR PRLNKID ONE 7
2 ABC123 NV NVLNKID MANY 7
3 ABC123 AG AGLNKID ONE 8
DR
4 ABC123 NV NVLNKID MANY 8
5 ABC123 NV NVREFID MANY 9
6 ABC123 DU DUREFID MANY 9
63
64
65 Example 2
66 Multiple Sclerosis – Visual Evoked Potential
67
68 The following examples show how to represent components of a pattern-reversal visual evoked potential (VEP) test elicited by checkerboard stimuli from a
69 subject with optic neuritis. VEPs are detected via an electroencephalogram (EEG) using leads that are placed on the back of the subject’s head. It is important to
70 note that the nature of VEP testing is such that NVMETHOD should be equal to “EEG”, and that NVCAT should be equal to “VISUAL EVOKED
71 POTENTIAL”. Several latencies from each eye including N75, P100, and N145 as well as the P100 peak-to-peak amplitude (75-100) are collected and should be
72 represented in NVTESTCD/NVTEST. Details about the VEP equipment including the checkerboard size should be represented in the appropriate device
73 domains. To interpret, each VEP component is compared against normative values established by the laboratory using healthy controls. In this example, a VEP
74 component is considered abnormal if it falls outside of three standard deviations from the normative lab mean. These low and high values are stored in

© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved NV - Page 5
Draft January 20, 2015
 CDISC SDTM Implementation Guide (Version 3.3 Draft)

75 NVORNRLO and NVORNRHI respectively and the interpretation of each VEP component is represented in NVNRIND. In addition to interpreting each VEP
76 component as normal or abnormal, the overall test for each eye may have an interpretation. In this scenario, NVTESTCD/NVTEST should be equal to
77 INTP/Interpretation and NVORRES should represent whether the overall test in each eye is normal or abnormal. NVGRPID links the each VEP component to
78 the overall interpretation.
79
80 The NV domain should be used to represent the VEP latencies, P100 peak-to-peak amplitude, and their interpretations. SPDEVID allows the results to be related
81 to both the VEP testing device as well as the checkerboard size.
82
83 Rows 1-4: Show the VEP measurements from the right eye.

T
84 Row 5: Shows that when all the components of right eye VEP are considered together (NVGRPID = 1), the overall test is interpreted as abnormal.
85 Rows 6-9: Show the VEP measurements from the left eye.
86 Row 10: Shows that when all the components of left eye VEP are considered together (NVGRPID = 2), the overall test is interpreted as abnormal.
87
88 nv.xpt

AF
Row STUDYID DOMAIN USUBJID EXPUNIT SPDEVID NVSEQ NVGRPID NVTESTCD NVTEST NVCAT NVORRES NVORRESU
1 MS123 NV MS01-01 OD 123 1 1 N75LAT N75 Latency VISUAL EVOKED POTENTIAL 79.8 ms
2 MS123 NV MS01-01 OD 123 2 1 P100LAT P100 Latency VISUAL EVOKED POTENTIAL 129 ms
3 MS123 NV MS01-01 OD 123 3 1 N145LAT N145 Latency VISUAL EVOKED POTENTIAL 181 ms
4 MS123 NV MS01-01 OD 123 4 1 P100AMP P100 Amplitude VISUAL EVOKED POTENTIAL 5.02 uV
5 MS123 NV MS01-01 OD 123 5 1 INTP Interpretation VISUAL EVOKED POTENTIAL ABNORMAL
6 MS123 NV MS01-01 OS 123 6 2 N75LAT N75 Latency VISUAL EVOKED POTENTIAL 83.8 ms
7 MS123 NV MS01-01 OS 123 7 2 P100LAT P100 Latency VISUAL EVOKED POTENTIAL 126 ms
8 MS123 NV MS01-01 OS 123 8 2 N145LAT N145 Latency VISUAL EVOKED POTENTIAL 160 ms
9 MS123 NV MS01-01 OS 123 9 2 P100AMP P100 Amplitude VISUAL EVOKED POTENTIAL 4.37 uV
10 MS123 NV MS01-01 OS 123 10 2 INTP Interpretation VISUAL EVOKED POTENTIAL ABNORMAL
89
Row NVSTRESC NVSTRESN NVSTRESU NVORNRLO NVORNRHI NVNRIND NVLOC NVLAT NVMETHOD NVDTC
DR
1 (cont) 79.8 79.8 ms 54.68 94 NORMAL EYE RIGHT EEG 2013-02-08
2 (cont) 129 129 ms 76.75 113.71 ABNORMAL EYE RIGHT EEG 2013-02-08
3 (cont) 181 181 ms 114.27 156.03 ABNORMAL EYE RIGHT EEG 2013-02-08
4 (cont) 5.02 5.02 uV 5.26 12.64 ABNORMAL EYE RIGHT EEG 2013-02-08
5 (cont) ABNORMAL EYE RIGHT EEG 2013-02-08
6 (cont) 83.8 83.8 ms 54.42 95.1 NORMAL EYE LEFT EEG 2013-02-08
7 (cont) 126 126 ms 76.9 115.78 ABNORMAL EYE LEFT EEG 2013-02-08
8 (cont) 160 160 ms 115.65 157.65 ABNORMAL EYE LEFT EEG 2013-02-08
9 (cont) 4.37 4.37 uV 4.78 12.7 ABNORMAL EYE LEFT EEG 2013-02-08
10 (cont) ABNORMAL EYE LEFT EEG 2013-02-08
90
91 Identifying information about the VEP device is represented in the Device Identifiers (DI) domain.
92
93 Row 1: Shows how to represent the VEP testing device as a device type. SPDEVID allows the device to be connected to both the testing device properties
94 as well as the results generated.
95

© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved NV - Page 6
Draft January 20, 2015
 CDISC SDTM Implementation Guide (Version 3.3 Draft)

96 di.xpt
Row STUDYID DOMAIN SPDEVID DISEQ DIPARMCD DIPARM DIVAL
1 MS123 DI 123 1 TYPE Device Type VEP Testing Device
97
98 Properties of the VEP device that may change between assessments are represented in the Device In-Use (DU) domain.
99
100 Row 1: Shows how to represent the checkerboard stimuli size in the DU Domain. SPDEVID allows the checkerboard size to be related to both the VEP
101 testing device as well as the results generated.
102

T
103 du.xpt
Row STUDYID DOMAIN USUBJID SPDEVID DUSEQ DUTESTCD DUTEST DUORRES
1 MS123 DU MS01-01 123 1 CHCKSIZE Checkerboard Size 32X32
104
105

AF
DR
© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved NV - Page 7
Draft January 20, 2015