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Short name of a specific trial set, as defined by the sponsor. Maximum 8 characters. This represents the trial set for which parameters are being submitted

Shareqc_sdtm21_ds

Purpose	Findings

#

Variable Name

Variable Label

Type

Format

Role

Variable(s) Qualified

Usage Restrictions

Variable C-code

Definition

Notes

Examples

1

--TESTCD

Short Name of Measurement, Test, or Exam

Char

Topic

C82503

The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination.

Used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters.

"PLAT", "SYSBP", "RRMIN", "EYEEXAM"

2

--TEST

Name of Measurement, Test, or Exam

Char

Synonym Qualifier

--TESTCD

C82541

The standardized or dictionary-derived name of the measurement, test, or examination.

"Platelets", "Systolic Blood Pressure", "Summary (Min) RR Duration", "Eye Examination"

3

--SBMRKS

Sublineage Marker String

Char

Variable Qualifier

--TESTCD

CP domain only

Used to further subset the cell population identified in CPTEST based on the use of additional marker(s) that define a sublineage. The value in CPSBMRKS is used in combination with values in CPTEST and CPCELSTA to fully describe the cell population being measured. As such, it is an essential component of the full test name.

Three unnamed sublineages of monocytes have been identified: CCR2+CD16-; CCR2-CD16+; and CCR2+CD16+. Whereas the entire monocyte cell population can be defined as CD14+ cells, the additional CCR2 and CD16 markers are used to differentiate one sublineage from another, none of which has yet been given a name by the scientific community. By combining the CPTEST value of "Monocyte Subset" with the value of "CCR2+CD16-" in CPSBMRKS, the full test is defined to be the CCR2+CD16- monocyte subpopulation.

4

--CELSTA

Cell State

Char

Variable Qualifier

--TESTCD

CP domain only

A textual description of a subset of the cell population identified in CPTEST based on a particular functional and/or biological state (e.g., primed, activated, proliferating, senescent, G2-arrested). When populated, the values in CPCELSTA and CPSMRKS, in combination with values in CPTEST and CPSBMRKS, fully describe the cell population being measured.

5

--CSMRKS

Cell State Marker String

Char

Variable Qualifier

--TESTCD

CP domain only

Identifies the marker(s) or indicator(s) used to define the cell state (i.e., the value in CPCELSTA).

When Ki67 expression is used to determine that a cell population is in a proliferating state (i.e., CPCELSTA value = "PROLIFERATING"), the value "Ki67+" in CPCSMRKS indicates that positive expression of Ki67 was used to define the population as proliferating. Similarly, a value of "Ki67-" in CPCSMRKS would indicate that lack of expression of Ki67 defined the "NON-PROLIFERATING" cell state in CPCELSTA. The CPCSMRKS value is useful for quickly determining which marker(s) were used to classify (i.e., operationally define) a cell population based on a functional/biological state.

6

--CNTMOD

Contact Mode

Char

Record Qualifier

The way in which the measurement, test, or examination was conducted.

7

--EPCHGI

Epi/Pandemic Related Change Indicator

Char

Record Qualifier

Indicates whether the measurement, test, or examination was changed due to an epidemic or pandemic.

8

--TSTCND

Test Condition

Char

Variable Qualifier

--TESTCD

CP, IS, and LB domains only

Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed.

Stimulating or activating agents, assay temperature, incubation time

"STIMULATED", "NON-STIMULATED", "25 C", "37 C".

9

--CNDAGT

Test Condition Agent

Char

Record Qualifier

CP, IS, and LB domains only

The textual description of the agent used to impose a test condition identified in CPTSTCND. For example, records might be produced for the same test run under stimulating (CPTSTCND value = "STIMULATED") conditions produced by different stimulating agents.

"Phorbol myristate acetate", "Concanavalin A, PHA-P", "TNF-alpha, Ionomycin", "Candida antigen"

10

--BDAGNT

Binding Agent

Char

Variable Qualifier

--TESTCD

CP, IS, and LB domains only

The textual description of the agent that's binding to the entity in the --TEST variable. The --BDAGNT variable is used to indicate that there is a binding relationship between the entities in the --TEST and --BDAGNT variables, regardless of direction.

--BDAGNT is not a method qualifier. It should only be used when the actual interest of the measurement is the binding interaction between the two entities in --TEST and --BDAGNT. In other words, the combination of --TEST and --BDAGNT should describe the thing, the entity, or the analyte being measured, without the need for additional variables.

The binding agent may be, but is not limited to, a test article, a portion of the test article, a related compound, an endogenous molecule, an allergen, or an infectious agent.

11

--ABCLID

Antibody Clone Identifier

Char

Record Qualifier

CP domain only

Identifies the antibody clone (e.g., supplier-provided catalog name) used to confer specificity for the binding agent specified in CPBDAGNT.

12

--MRKSTR

Marker String

Char

Record Qualifier

CP domain only

The text string identifying the full set of markers/indicators used by the laboratory to operationally define the complete test. Because laboratories often use different markers/indicators to identify a cell population, the relationship between a named cell population in CPTEST (as combined with CPSBMRKS and CPCELSTA values) and the set of markers used to identify that population is many-to-one. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different sets of markers, it is necessary to operationally define the test in terms of the markers/indicators used to perform that test.

13

--GATE

Gate

Char

Record Qualifier

CP domain only

The sponsor-defined name assigned to a gate. Gates are electronic (device setting or software-defined) boundaries set by a user to virtually parse a specimen into discrete populations based on a set of defined characteristics (e.g., presence, absence, or intensity of expression of various markers; physical size; internal complexity or granularity). Gates are used to constrain data collection or analysis to a specific cell population or region of interest within the specimen.

14

--GATDEF

Gate Definition

Char

Record Qualifier

CP domain only

The text string identifying the set of parameters and the order in which they are applied to define the gating strategy. In practice, a series of 2-dimensional subgates based on 2 different cell characteristics (i.e., markers/indicators/physical properties) are most often combined until the cell population of interest is sufficiently resolved (i.e., electronically isolated) from other cell populations contained within the specimen.

For complex analyses, differences in gating strategies can produce subtle differences in results obtained for a test. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different gating strategies, it is often necessary to qualify the test in terms of the gating strategy. For some purposes, however, and at the discretion of the sponsor, only the ultimate or penultimate gate is identified. When specifying the gating strategy in CPGATDEF, each subgate should be listed in the order it was applied and separated from the next sub-gate using the vertical line or pipe character ("|").

15

--TSTOPO

Test Operational Objective

Char

Variable Qualifier

--TESTCD

The textual description of the high-level purpose of the test at the operational level.

"SCREEN", "CONFIRM", "QUANTIFY"

16

--MSCBCE

Molecule Secreted by Cells

Char

Variable Qualifier

--TESTCD

IS domain only

The textual description of the entity secreted by the cells represented in --TEST. The combination of --TEST and --MSBCE should describe the thing, the entity, or the analyte being measured, without the need for additional variables.

17

--AGENT

Agent Name

Char

Record Qualifier

MS Domain only

The name of the drug or other material for which resistance is tested. The agent may be used for in vitro testing or may be used in tests for genetic markers or in direct phenotypic drug-sensitivity testing.

18

--CONC

Agent Concentration

Num

Variable Qualifier

--AGENT

MS Domain only

The amount of drug or other material listed in MSAGENT per unit volume or weight. Used when the agent is part of the prespecified test. Not to be used when the concentration is a result of a test such as minimal inhibitory concentration, IC50, or EC50.

19

--CONCU

Agent Concentration Units

Char

Variable Qualifier

--CONC

MS Domain only

Unit of measure for MSCONC.

20

--MODIFY

Modified Result Term

Char

Synonym Qualifier

--ORRES

C170998

A value which represents an alteration to a collected value for coding purposes.

21

--TSTDTL

Measurement, Test, or Examination Detail

Char

Variable Qualifier

--TESTCD

Further description of --TESTCD and --TEST.

"STAINING INTENSITY" when MITEST="Human Epidermal Growth Factor Receptor 2"

22

--SPTSTD

Sponsor Test Description

Char

Record Qualifier

CP domain only

Sponsor's description of a test. This variable is particularly valuable for identifying the cell population on which certain tests are conducted when it is not identified in the Test Name (CPTEST; e.g., tests for quantitative expression of a particular marker).

23

--CAT

Category

Char

Grouping Qualifier

C25372

A grouping or classification of the topic of the finding, event, or intervention.

"HEMATOLOGY", "URINALYSIS", "CHEMISTRY", "HAMD 17", "SF36 V2.0 ACUTE", "EGFR MUTATION ANALYSIS"

24

--SCAT

Subcategory

Char

Grouping Qualifier

C25692

A further grouping or classification of the category for the topic of the finding, event, or intervention.

The category is in --CAT.

"WBC DIFFERENTIAL"

25

--TSTPNL

Test Panel

Char

Grouping Qualifier

CP domain only

Sponsor-defined textual description used to group tests run together as part of a test panel. Can be used with --GRPID to ensure that relationships between associated tests are accurately identified.

26

--POS

Position of Subject During Observation

Char

Record Qualifier

C171002

The particular way that a subject's body is placed or situated during an assessment.

"SUPINE", "STANDING", "SITTING"

27

--BODSYS

Body System or Organ Class

Char

Record Qualifier

C170986

A standardized or dictionary-derived name for the body system or organ class.

MedDRA SOC

28

--ORRES

Result or Finding in Original Units

Char

Result Qualifier

C117221

The result of the measurement, test, or examination, as originally received or collected.

"120", "<1", "POS"

29

--ORRESU

Original Units

Char

Variable Qualifier

--ORRES; --ORNRLO; --ORNRHI; --ORREF

C82586

The unit of measure for the result (as originally received or collected) of the measurement, test, or examination.

Unit for --ORRES and --ORREF.

"in", "LB", "kg/L"

30

--CELLEV

Status

colour	Red
title	NEW

Number of Cells Evaluated

Num

Result Qualifier

The number of cells evaluated.

"150"

31

--RESSCL

Result Scale

Char

Record Qualifier

Classifies the scale of the original result value with respect to whether the result is, for example, ordinal, nominal, quantitative, or narrative.

"NARRATIVE", "NOMINAL", "ORDINAL", "QUANTITATIVE"

32

--RESTYP

Result Type

Char

Record Qualifier

Classifies the kind of result (i.e., property type) originally reported for the test.

"SUBSTANCE CONCENTRATION", "MASS RATE", "ARBITRARY CONCENTRATION"

33

--COLSRT

Collected Summary Result Type

Char

Variable Qualifier

--TESTCD

Used to indicate the type of a collected summary result. This is used for summary results collected on a CRF or provided by an external vendor (e.g., central lab).

In human clinical trials:

If the summary result is derived by the sponsor using individual source data records, the summary result is represented in ADaM. If a sponsor has both a collected or vendor-provided summary result and a derived summary result, the collected or vendor-provided summary result is represented in SDTM and the derived summary result is represented in ADaM.	"MAXIMUM", "MINIMUM", "MEAN", "MEDIAN", "NADIR"
34	--ORNRLO	Normal Range Lower Limit-Original Units	Char	Variable Qualifier	--ORRES		C82580	The lowest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination.
35	--ORNRHI	Normal Range Upper Limit-Original Units	Char	Variable Qualifier	--ORRES		C70933	The highest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination.
36	--ORREF	Reference Result in Original Units	Char	Variable Qualifier	--ORRES				Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable.	Value from predicted normal value in spirometry tests.
37	--LLOD	Lower Limit of Detection	Char	Variable Qualifier	--TESTCD				The lowest threshold (as originally received or collected) for reliably detecting the presence or absence of substance measured by a specific test. The value for the field will be as described in documentation from the instrument or lab vendor.
38	--STRESC	Result or Finding in Standard Format	Char	Result Qualifier			C117222	The standardized result of the measurement, test, or examination, in character format.	--STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN.	If various tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these results effectively have the same meaning, they could be represented in standard format in --STRESC as "NEGATIVE".
39	--IMPLBL	Implantation Site Label	Char	Record Qualifier		Not in human clinical trials; IC Domain only			Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn) when classifying implantations during a uterine examination in a reproductive toxicology study.
40	--STRESN	Numeric Result/Finding in Standard Units	Num	Result Qualifier			C171009	The standardized result of the measurement, test, or examination in numeric format.	Copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings.
41	--STRESU	Standard Units	Char	Variable Qualifier	--STRESC; --STRESN; --STNRLO; --STNRHI; --STREFC; --STREFN; --LLOQ; --ULOQ		C82587	The unit of measure for the standardized result of the measurement, test, or examination.		"mol/L"
42	--STNRLO	Normal Range Lower Limit-Standard Units	Num	Variable Qualifier	--STRESC; --STRESN		C171008	The lowest value in a normal or reference range for the standardized result of the measurement, test, or examination.
43	--STNRHI	Normal Range Upper Limit-Standard Units	Num	Variable Qualifier	--STRESC; --STRESN		C171007	The highest value in a normal or reference range for the standardized result of the measurement, test, or examination.
44	--STNRC	Normal Range for Character Results	Char	Variable Qualifier	--STRESC		C171006	A set of normal or reference values for the standardized character result, in an ordinal scale or categorical grouping.		"Negative to Trace"
45	--STREFC	Reference Result in Standard Format	Char	Variable Qualifier	--STRESC				Reference value for the result or finding copied or derived from --ORREF in a standard format.
46	--STREFN	Numeric Reference Result in Std Units	Num	Variable Qualifier	--STRESN				Reference value for continuous or numeric results or findings in standard format or in standard units. --STREFN uses the same units as --STRESN, if applicable.
47	--NRIND	Normal/Reference Range Indicator	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN		C170999	A classification of the original or standardized result as it relates to a normal or reference result range.	May be defined by --ORNRLO and --ORNRHI or other objective criteria.	"Y", "N"; "HIGH", "LOW"; "NORMAL", "ABNORMAL"
48	--RESCAT	Result Category	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN		C82498	A grouping or classification of the results of an assessment.	The result is in --STRESC.	"MALIGNANT" or "BENIGN" for tumor findings
49	--INHERT	Inheritability	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			Identifies whether the variation can be passed to the next generation.
50	--GENREF	Genome Reference	Char	Variable Qualifier	--METHOD	GF domain only			An identifier for the genome reference used to generate the reported result.	For example, Genome Reference Consortium Human Build 38 patch release 13 may be represented as GRCh38.p13.
51	--CHROM	Chromosome Identifier	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			The designation (name or number) of the chromosome or contig on which the variant or other feature appears.	"17", "X"
52	--SYM	Genomic Symbol	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			A published symbol for the portion of the genome serving as a locus for the experiment/test.
53	--SYMTYP	Genomic Symbol Type	Char	Variable Qualifier	--SYM	GF domain only			A description of the type of genomic entity that is represented by the published symbol in --SYM.
54	--GENLOC	Genetic Location	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			Specifies the location within a sequence for the observed value in --ORRES.
55	--GENSR	Genetic Sub-Region	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			The portion of the locus in which the variation was found.	"Exon 15", "Kinase domain"
56	--SEQID	Sequence Identifier	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			A unique identifier for the sequence used as the reference to identify the genetic variation in the result.	"NM_001234", "ENSG00000182533", "ENST00000343849.2"
57	--PVRID	Published Variant Identifier	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			A unique identifier for the variation that has been publicly characterized in an external database.	"rs2231142", "COSM41596"
58	--COPYID	Copy Identifier	Char	Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			An arbitrary identifier used to differentiate between copies of a genetic target of interest present on homologous chromosomes.
59	--CHRON	Chronicity of Finding	Char	Variable Qualifier	--STRESC				Characterization of the duration of a biological process resulting in a particular finding.	"ACUTE", "CHRONIC", "SUBACUTE"
60	--DISTR	Distribution Pattern of Finding	Char	Variable Qualifier	--STRESC				Description of the distribution pattern of a finding within the examined area.	"FOCAL", "MULTIFOCAL", "DIFFUSE"
61	--RESLOC	Result Location of Finding	Char	Record Qualifier		Not in human clinical trials	C170500	Anatomical location where the result was observed.	Location where the result was observed (as opposed to the location specified for examination). This location may have a higher degree of specificity than the location specified for examination.	"PINNA" when --LOC is "EAR" "LUNG, LEFT LOWER LOBE" where --LOC is "CHEST" "CORTEX" when --SPEC is "KIDNEY"
62	--STAT	Completion Status	Char	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".
63	--REASND	Reason Not Done	Char	Record Qualifier			C82556	The explanation for why requested information was not available.	Used in conjunction with --STAT when value is "NOT DONE".
64	--XFN	External File Path	Char	Record Qualifier			C82536	The filename and/or path to external data not stored in the same format and possibly not the same location as the other data for a study.		A filename and/or path for an ECG waveform or a medical image.
65	--NAM	Laboratory/Vendor Name	Char	Record Qualifier			C117200	The name of the vendor performing an assessment.		A laboratory name.
66	--LOINC	LOINC Code	Char	Record Qualifier			C82502	A short sequence of characters used to represent laboratory and clinical tests within the Logical Observation Identifiers Names and Codes (LOINC) database.
67	--SPEC	Specimen Material Type	Char	Record Qualifier			C70713	The

substance that is assayed to measure an analyte

type of sample material taken from a product or biological entity.		"SERUM", "PLASMA", "URINE", "DNA", "RNA", "LIVER", "KIDNEY", "SMOKE CONDENSATE", "TOBACCO PARTICULATE MATTER"
68	--ANTREG	Anatomical Region	Char	Variable Qualifier	--SPEC		C170983	The specific anatomical or biological region of a tissue or organ specimen.	As defined in the protocol. A section or part of what is described in the --SPEC variable.	"CORTEX", "MEDULLA", "MUCOSA"
69	--SPCCND	Specimen Condition	Char	Record Qualifier			C70714	The physical state or quality of a sample for assessment.		"CLOUDY"
70	--SPCUFL	Specimen Usability for the Test	Char	Record Qualifier			C171004	An indication as to whether a sample is suitable for testing.	The value will be "N" if the specimen is not usable, and null if the specimen is usable.
71	--LOC	Location Used for the Measurement	Char	Record Qualifier					Anatomical location of the subject relevant to the collection of the measurement.	"RECTUM" for temperature, "ARM" for blood pressure
72	--LAT	Laterality	Char	Variable Qualifier	--LOC; --SPEC				Qualifier for anatomical location or specimen further detailing laterality.	"RIGHT", "LEFT", "BILATERAL"
73	--DIR	Directionality	Char	Variable Qualifier	--LOC; --SPEC				Qualifier for anatomical location or specimen further detailing directionality.	"ANTERIOR", "LOWER", "PROXIMAL"
74	--PORTOT	Portion or Totality	Char	Variable Qualifier	--LOC; --SPEC				Qualifier for anatomical location or specimen further detailing the distribution (i.e., arrangement or apportioning of).	"ENTIRE", "SINGLE", "SEGMENT", "MANY"
75	--METHOD	Method of Test or Examination	Char	Record Qualifier					Method of the test or examination.	"EIA" (enzyme immunoassay), "ELECTROPHORESIS", "DIPSTICK"
76	--RUNID	Run ID	Char	Record Qualifier			C117058	A sequence of characters used to uniquely identify a particular run of a test on a particular batch of samples.
77	--ANMETH	Analysis Method	Char	Record Qualifier					Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence).
78	--TMTHSN	Test Method Sensitivity	Char	Record Qualifier					The sensitivity of the test methodology with respect to observation, detection, or quantification.	"LOW SENSITIVITY", "HIGH SENSITIVITY", "ULTRA-HIGH SENSITIVITY"
79	--LEAD	Lead Identified to Collect Measurements	Char	Record Qualifier			C170997	An electrical recording from some region of the body that represents the voltage difference between 2 electrodes.		"LEAD I", "LEAD V2", "LEAD CM5"
80	--CSTATE	Consciousness State	Char	Record Qualifier			C88429	The subject's level of consciousness.		"CONSCIOUS", "SEMI-CONSCIOUS", "UNCONSCIOUS"
81	--LOBXFL	Last Observation Before Exposure Flag	Char	Record Qualifier					Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null.
82	--BLFL	Baseline Flag	Char	Record Qualifier			C82526	An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation.	Result value is in --STRESC. Should be "Y" or null.
83	--FAST	Fasting Status	Char	Record Qualifier			C93566	An indication as to whether a subject has abstained from food and liquid for a prescribed amount of time.	Valid values include "Y", "N", "U", or null if not relevant.
84	--DRVFL	Derived Flag	Char	Record Qualifier			C81197	An indication that the measurement or finding is not a collected value but is processed or computed by the sponsor from collected data.	Should be "Y" or null.	The average of other records used as a computed baseline.
85	--EVAL	Evaluator	Char	Record Qualifier		Not in QS, FT, and clinical classifications use case of RS	C51824	The role of the person(s) providing an evaluation, appraisal, or interpretation.	Used only for results that are subjective (e.g., assigned by a person or a group).	"ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR"
86	--EVALID	Evaluator Identifier	Char	Variable Qualifier	--EVAL	Not in QS, FT, and clinical classifications use case of RS	C117043	A sequence of characters used to uniquely identify the evaluator(s).	Used to distinguish multiple evaluators with the same role recorded in --EVAL.	"RADIOLOGIST1", "RADIOLOGIST2"
87	--ACPTFL	Accepted Record Flag	Char	Record Qualifier			C117038	An indication that a record is the endorsed assessment.	Expected values can include "Y", "N", or null. This is not intended to be an analysis flag to indicate acceptability for a given analysis.
88	--TOX	Toxicity	Char	Variable Qualifier	--TOXGR		C27990	The standardized or dictionary-derived name for an untoward event or finding.	Sponsors should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.	An NCI CTCAE Short Name. "HYPERCALCEMIA", "HYPOCALCEMIA"
89	--TOXGR	Toxicity Grade	Char	Record Qualifier			C82528	A categorical classification of the severity of an event or finding, based on a standard scale, used in study data tabulation.	Sponsors should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.	A grade from the NCI CTCAE. "2"
90	--SEV	Severity/Intensity	Char	Record Qualifier			C25676	The quality or degree of harm associated with a finding or event, as collected.		"MILD", "MODERATE", "SEVERE"
91	--CLSIG	Clinically Significant, Collected	Char	Record Qualifier			C93532	An indication as to whether an observation is clinically significant based on judgment.	For collected assessments of clinical significance of a result.	"Y", "N"
92	--DTHREL	Relationship to Death	Char	Record Qualifier		Not in human clinical trials	C82563	An indication that a particular finding is related to the cause of death.		"Y", "N", or "U"
93	--LLOQ	Lower Limit of Quantitation	Num	Variable Qualifier	--STRESC; --STRESN		C82589	The lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units.	Units will be those used for --STRESU.
94	--ULOQ	Upper Limit of Quantitation	Num	Variable Qualifier	--STRESC; --STRESN		C85533	The highest threshold for reliably detecting the result of a specific test in standardized units.	Units will be those used for --STRESU.
95	--REASPF	Reason Test Performed	Char	Record Qualifier			C171003	The explanation for why a test, measurement, or assessment is executed.
96	--EXCLFL	Exclude from Statistics	Char	Record Qualifier		Not in human clinical trials	C117045	An indication that the result is to be excluded from all calculations.	Expected to be "Y" or null. --EXCLFL should be null when --STAT is "NOT DONE".
97	--REASEX	Reason for Exclusion from Statistics	Char	Record Qualifier		Not in human clinical trials	C117057	The explanation for why a result is excluded from all calculations.	Used in conjunction with --EXCLFL when its value is "Y".
98	--USCHFL	Unscheduled Flag	Char	Record Qualifier		Not in human clinical trials	C170510	An indication that the performed test or observation was done at a time that was not planned.	If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used.
99	--REPNUM	Repetition Number	Num	Record Qualifier					The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point or within a visit).	Multiple measurements of blood pressure or multiple analyses of a sample.
100	--RSTIND	Restraint Indicator	Char	Record Qualifier		Not in human clinical trials			An indicator as to whether the animal was restrained during the observation period. Expected values are "Y" or null.
101	--RSTMOD	Restraint Mode	Char	Record Qualifier		Not in human clinical trials			A description of whether the restraint was physical and/or chemical

.

102

SETCD

Set Code

Char

Identifier

Tobacco IG only

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-126

The short sequence of characters used to represent the trial set.

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