# | 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 |
| | --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 | | 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 |
|
|
| 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 | | 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" |
31 | --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" |
32 | --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). 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" |
33 | --ORNRLO | Normal Range Lower Limit-Original Units | Char |
| Variable Qualifier | |
| C82580 | The lowest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination. |
|
|
34 | --ORNRHI | Normal Range Upper Limit-Original Units | Char |
| Variable Qualifier | |
| C70933 | The highest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination. |
|
|
35 | --ORREF | Reference Result in Original Units | Char |
| Variable Qualifier | |
|
|
| 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. |
36 | --LLOD | Lower Limit of Detection | Char |
| Variable Qualifier | |
|
|
| 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. |
|
37 | --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". |
38 | --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. |
|
39 | --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. |
|
40 | --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" |
41 | --STNRLO | Normal Range Lower Limit-Standard Units | Num |
| Variable Qualifier | |
| C171008 | The lowest value in a normal or reference range for the standardized result of the measurement, test, or examination. |
|
|
42 | --STNRHI | Normal Range Upper Limit-Standard Units | Num |
| Variable Qualifier | |
| C171007 | The highest value in a normal or reference range for the standardized result of the measurement, test, or examination. |
|
|
43 | --STNRC | Normal Range for Character Results | Char |
| Variable Qualifier | |
| C171006 | A set of normal or reference values for the standardized character result, in an ordinal scale or categorical grouping. |
| "Negative to Trace" |
44 | --STREFC | Reference Result in Standard Format | Char |
| Variable Qualifier | |
|
|
| Reference value for the result or finding copied or derived from --ORREF in a standard format. |
|
45 | --STREFN | Numeric Reference Result in Std Units | Num |
| Variable Qualifier | |
|
|
| 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. |
|
46 | --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" |
47 | --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 |
48 | --INHERT | Inheritability | Char |
| Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only |
|
| Identifies whether the variation can be passed to the next generation. |
|
49 | --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. |
50 | --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" |
51 | --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. |
|
52 | --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. |
|
53 | --GENLOC | Genetic Location | Char |
| Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only |
|
| Specifies the location within a sequence for the observed value in --ORRES. |
|
54 | --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" |
55 | --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" |
56 | --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" |
57 | --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. |
|
58 | --CHRON | Chronicity of Finding | Char |
| Variable Qualifier | --STRESC |
|
|
| Characterization of the duration of a biological process resulting in a particular finding. | "ACUTE", "CHRONIC", "SUBACUTE" |
59 | --DISTR | Distribution Pattern of Finding | Char |
| Variable Qualifier | --STRESC |
|
|
| Description of the distribution pattern of a finding within the examined area. | "FOCAL", "MULTIFOCAL", "DIFFUSE" |
60 | --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" |
61 | --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". |
|
62 | --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". |
|
63 | --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. |
64 | --NAM | Laboratory/Vendor Name | Char |
| Record Qualifier |
|
| C117200 | The name of the vendor performing an assessment. |
| A laboratory name. |
65 | --LOINC | LOINC Code | Char |
| |
|
| C82502 | A short sequence of characters used to represent laboratory and clinical tests within the Logical Observation Identifiers Names and Codes (LOINC) database. |
|
|
66 | --SPEC | Specimen Material Type | Char |
| Record Qualifier |
|
| C70713 | The |