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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.

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.

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

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

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

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

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.

CP, IS, and LB domains only

--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.

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

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.

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.

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 ("|").

Variable Qualifier

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

Molecule Secreted by Cells

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.

Modified Result Term

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

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).

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.

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

--RESSCL

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

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

Collected Summary Result Type

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.

--ORRES

--ORRES

--ORRES

--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.

--STRESC; --STRESN; --STNRLO; --STNRHI; --STREFC; --STREFN; --LLOQ; --ULOQ

--STRESC; --STRESN

--STRESC; --STRESN

--STRESC

--STRESC

--STRESN

--ORRES; --STRESC; --STRESN

Identifies whether the variation can be passed to the next generation.

An identifier for the genome reference used to generate the reported result.

The designation (name or number) of the chromosome or contig on which the variant or other feature appears.

A published symbol for the portion of the genome serving as a locus for the experiment/test.

A description of the type of genomic entity that is represented by the published symbol in --SYM.

Specifies the location within a sequence for the observed value in --ORRES.

The portion of the locus in which the variation was found.

A unique identifier for the sequence used as the reference to identify the genetic variation in the result.

A unique identifier for the variation that has been publicly characterized in an external database.

An arbitrary identifier used to differentiate between copies of a genetic target of interest present on homologous chromosomes.

Not in human clinical trials

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.

Record Qualifier

Record Qualifier

Variable Qualifier

The sensitivity of the test methodology with respect to observation, detection, or quantification.

Expected values can include "Y", "N", or null. This is not intended to be an analysis flag to indicate acceptability for a given analysis.

--CLSIG

For collected assessments of clinical significance of a result.

Expected to be "Y" or null. --EXCLFL should be null when --STAT is "NOT DONE".

An indication that the performed test or observation was done at a time that was not planned.

An indicator as to whether the animal was restrained during the observation period. Expected values are "Y" or null.

Restraint Mode

A description of whether the restraint was physical and/or chemical.

Set Code

Tobacco IG only

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.