Variable Name,Variable Label,Type,Role,Description
Topic Variable,,,,
--TESTCD,"Short Name of Measurement, Test or Examination",Char,Topic,"Short character value for --TEST 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. Examples: PLAT, SYSBP, RRMIN, EYEEXAM."
Qualifier Variables,,,,
--TEST,"Name of Measurement, Test or Examination",Char,Synonym Qualifier of --TESTCD,"Long name For --TESTCD. Examples: Platelet, Systolic Blood Pressure, Summary (Min) RR Duration, Eye Examination."
--MODIFY,Modified Term,Char,Synonym Qualifier of --ORRES,"If the value of --ORRES is modified for coding purposes, then the modified text is placed here."
--TSTDTL,"Measurement, Test or Examination Detail",Char,Variable Qualifier of --TESTCD and --TEST,"Further description of --TESTCD and --TEST. Example: ""The percentage of cells with +1 intensity of staining"" when MITEST = Thyroid Transcription Factor 1."
--CAT,Category,Char,Grouping Qualifier,"Used to define a category of topic-variable values. Examples: HEMATOLOGY, URINALYSIS, CHEMISTRY, HAMD 17, SF36 V2.0 ACUTE, EGFR MUTATION ANALYSIS."
--SCAT,Subcategory,Char,Grouping Qualifier,Used to define a further categorization of --CAT values. Example: WBC DIFFERENTIAL.
--POS,Position of Subject During Observation,Char,Record Qualifier,"Position of the subject during a measurement or examination. Examples: SUPINE, STANDING, SITTING."
--BODSYS,Body System or Organ Class,Char,Record Qualifier,Body System or Organ Class that is involved for a finding from the standard hierarchy for dictionary-coded results. Example: MedDRA SOC.
--ORRES,Result or Finding in Original Units,Char,Result Qualifier,"Result of the measurement or finding as originally received or collected. Examples: 120, <1, POS."
--ORRESU,Original Units,Char,Variable Qualifier of --ORRES,"Unit for --ORRES. Examples: in, LB, kg/L."
--ORNRLO,Normal Range Lower Limit-Original Units,Char,Variable Qualifier of --ORRES,Lower end of normal range or reference range for results stored in --ORRES.
--ORNRHI,Normal Range Upper Limit-Original Units,Char,Variable Qualifier of --ORRES,Upper end of normal range or reference range for results stored in --ORRES.
--ORREF,Reference Result in Original Units,Char,Variable Qualifier of --ORRES,"Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable. Examples: value from predicted normal value in spirometry tests."
--STRESC,Result or Finding in Standard Format,Char,Result Qualifier,"Contains the result value for all findings, copied or derived from --ORRES in a standard format or in standard units. --STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN. For example, 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""."
--STRESN,Numeric Result/Finding in Standard Units,Num,Result Qualifier,Used for continuous or numeric results or findings in standard format; copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings.
--STRESU,Standard Units,Char,Variable Qualifier of --STRESC and --STRESN,Standardized units used for --STRESC and --STRESN. Example: mol/L.
--STNRLO,Normal Range Lower Limit-Standard Units,Num,Variable Qualifier of --STRESC and --STRESN,"Lower end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (--STRESU)."
--STNRHI,Normal Range Upper Limit-Standard Units,Num,Variable Qualifier of --STRESC and --STRESN,"Upper end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (--STRESU)."
--STNRC,Normal Range for Character Results,Char,Variable Qualifier of --STRESC,Normal range or reference range for results stored in --STRESC that are character in ordinal or categorical scale. Example: Negative to Trace.
--STREFC,Reference Result in Standard Format,Char,Variable Qualifier of --STRESC,Reference value for the result or finding copied or derived from --ORREF in a standard format.
--STREFN,Numeric Reference Result in Std Units,Num,Variable Qualifier of --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."
--NRIND,Normal/Reference Range Indicator,Char,Variable Qualifier of --ORRES,"Used to indicate the value is outside the normal range or reference range. May be defined by --ORNRLO and --ORNRHI or other objective criteria. Examples: Y, N; HIGH, LOW; NORMAL; ABNORMAL."
--RESCAT,Result Category,Char,Variable Qualifier of --ORRES,Used to categorize the result of a finding. Example: MALIGNANT or BENIGN for tumor findings. RESISTANCE VARIANT for genetic variation.
--CHRON,Chronicity of Finding,Char,Variable Qualifier of --STRESC,"Characterization of the duration of a biological process resulting in a particular finding. Examples: ACUTE, CHRONIC, SUBACUTE."
--DISTR,Distribution Pattern of Finding,Char,Variable Qualifier of --STRESC,"Description of the distribution pattern of a finding within the examined area. Examples: FOCAL, MULTIFOCAL, DIFFUSE, FOCAL MULTIFOCAL."
--RESLOC,Result Location of Finding,Char,Result Qualifier,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. Not to be used with human clinical trials.
--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."
--REASND,Reason Not Done,Char,Record Qualifier,Reason not done. Used in conjunction with --STAT when value is NOT DONE.
--XFN,External File Path,Char,Record Qualifier,"Filename for an external file, such as one for an ECG waveform or a medical image."
--NAM,Laboratory/Vendor Name,Char,Record Qualifier,"Name or identifier of the vendor (e.g., laboratory) that provided the test results."
--LOINC,LOINC Code,Char,Synonym Qualifier of --TESTCD,Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable such as a lab test.
--SPEC,Specimen Material Type,Char,Record Qualifier,"Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE, DNA, RNA."
--ANTREG,Anatomical Region,Char,Variable Qualifier of --SPEC,"Defines the specific anatomical or biological region of a tissue, organ specimen or the region from which the specimen is obtained, as defined in the protocol, such as a section or part of what is described in the --SPEC variable. Examples: CORTEX, MEDULLA, MUCOSA."
--SPCCND,Specimen Condition,Char,Record Qualifier,Defines the condition of the specimen. Example: CLOUDY.
--SPCUFL,Specimen Usability for the Test,Char,Record Qualifier,"Describes the usability of the specimen for the test. The value will be N if the specimen is not usable, and null if the specimen is usable."
--LOC,Location Used for the Measurement,Char,Record Qualifier,"Anatomical location of the subject relevant to the collection of the measurement. Examples: RECTAL for temperature, ARM for blood pressure."
--LAT,Laterality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location or specimen further detailing laterality. Examples: RIGHT, LEFT, BILATERAL."
--DIR,Directionality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location or specimen further detailing directionality. Examples: ANTERIOR, LOWER, PROXIMAL."
--PORTOT,Portion or Totality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY."
--METHOD,Method of Test or Examination,Char,Record Qualifier,"Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK."
--RUNID,Run ID,Char,Record Qualifier,A unique identifier for a particular run of a test on a particular batch of samples.
--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 or a genetic sequence).
--LEAD,Lead Identified to Collect Measurements,Char,Record Qualifier,"Lead or leads identified to capture the measurement for a test from an instrument. Examples: LEAD I, LEAD V2, LEAD CM5."
--CSTATE,Consciousness State,Char,Record Qualifier,"The consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS."
--LOBXFL,Last Observation Before Exposure Flag,Char,Record Qualifier,Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be Y or null.
--BLFL,Baseline Flag,Char,Record Qualifier,Indicator used to identify a baseline value. Should be Y or null.
--FAST,Fasting Status,Char,Record Qualifier,"Indicator used to identify fasting status. Valid values include Y, N, U, or null if not relevant."
--DRVFL,Derived Flag,Char,Record Qualifier,"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."
--EVAL,Evaluator,Char,Record Qualifier,"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."
--EVALID,Evaluator Identifier,Char,Variable Qualifier of --EVAL,"Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST1, RADIOLOGIST2."
--ACPTFL,Accepted Record Flag,Char,Record Qualifier,"In cases where more than one assessor provides an evaluation of a result or response, this flag identifies the record that is considered to be the accepted evaluation. Expected values can include Y, N or null. This is not intended to be an analysis flag to indicate acceptability for a given analysis."
--TOX,Toxicity,Char,Variable Qualifier of --TOXGR,"Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: HYPERCALCEMIA, HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document."
--TOXGR,Toxicity Grade,Char,Record Qualifier,Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define data definition document. Example: 2.
--SEV,Severity,Char,Record Qualifier,"Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE."
--DTHREL,Relationship to Death,Char,Record Qualifier,"Describes the relationship of a particular finding to the death of a subject. Examples: Y, N, or U. Not to be used with human clinical trials."
--LLOQ,Lower Limit of Quantitation,Num,Variable Qualifier of --STRESC and --STRESN,Indicates the lower limit of quantitation for an assay. Units will be those used for --STRESU.
--ULOQ,Upper Limit of Quantitation,Num,Variable Qualifier of --STRESC and --STRESN,Indicates the upper limit of quantitation for an assay. Units will be those used for --STRESU.
--EXCLFL,Exclude from Statistics,Char,Record Qualifier,"Indicates whether the values in the result variables for this record should be excluded from summary statistical calculations such as Mean, Standard Deviation, and Count (and others). Expected to be Y or null. --EXCLFL should not be used when --STAT is NOT DONE. Not to be used with human clinical trials."
--REASEX,Reason for Exclusion from Statistics,Char,Record Qualifier,Reason excluded from statistics. Used in conjunction with --EXCLFL when its value is Y. Not to be used with human clinical trials.
--USCHFL,Unscheduled Flag,Char,Record Qualifier,"Indicates whether the timing of a performed test or observation was unscheduled. 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. Not to be used with human clinical trials. 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."
--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. For example, multiple measurements of blood pressure or multiple analyses of a sample."
