"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
MITESTCD = TTF1."
--CAT ,Category ,Char ,"Grouping
Qualifier","Used to define a category of topic-variable values. Examples:
HEMATOLOGY, URINALYSIS, CHEMISTRY, HAMILTON
DEPRESSION SCALE, SF36, MICRO ARRAY, EGFR
MUTATION ANALYSIS"
--SCAT ,Subcategory ,Char ,"Grouping
Qualifier","Used to define a further categorization of --CAT values.
Example: 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."
--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."
--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."
--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"
--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 or
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, by an independent assessor, to be the accepted
evaluation. Expected to be Y or null."
--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."
--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"
