SDTM Laboratory Test Results (LB)

Description

A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains.

lb.xpt, Laboratory Test Results — Findings. One record per lab test per time point per visit per subject, Tabulation.

Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	LB	Identifier	Two-character abbreviation for the domain.	Req
USUBJID	Unique Subject Identifier	Char		Identifier	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.	Req
LBSEQ	Sequence Number	Num		Identifier	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req
LBGRPID	Group ID	Char		Identifier	Used to tie together a block of related records in a single domain for a subject.	Perm
LBREFID	Specimen ID	Char		Identifier	Internal or external specimen identifier. Example: Specimen ID.	Perm
LBSPID	Applicant-Defined Identifier	Char		Identifier	Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on the Lab page.	Perm
LBTESTCD	Lab Test or Examination Short Name.	Char	(LBTESTCD)	Topic	Short name of the measurement, test, or examination described in LBTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in LBTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). LBTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "ALT", "LDH".	Req
LBTEST	Lab Test or Examination Name	Char	(LBTEST)	Synonym Qualifier	Verbatim name of the test or examination used to obtain the measurement or finding. Note any test normally performed by a clinical laboratory is considered a lab test. The value in LBTEST cannot be longer than 40 characters. Examples: "Alanine Aminotransferase", "Lactate Dehydrogenase".	Req
LBCAT	Category for Lab Test	Char		Grouping Qualifier	Used to define a category of related records across subjects. Examples: "HEMATOLOGY", "URINALYSIS", "CHEMISTRY".	Exp
LBSCAT	Subcategory for Lab Test	Char		Grouping Qualifier	A further categorization of a test category such as "DIFFERENTIAL", "COAGULATION", "LIVER FUNCTION", "ELECTROLYTES".	Perm
LBORRES	Result or Finding in Original Units	Char		Result Qualifier	Result of the measurement or finding as originally received or collected.	Exp
LBORRESU	Original Units	Char	(UNIT)	Variable Qualifier	Original units in which the data were collected. The unit for LBORRES. Example: "g/L".	Exp
LBORNRLO	Reference Range Lower Limit in Orig Unit	Char		Variable Qualifier	Lower end of reference range for continuous measurement in original units. Should be populated only for continuous results.	Exp
LBORNRHI	Reference Range Upper Limit in Orig Unit	Char		Variable Qualifier	Upper end of reference range for continuous measurement in original units. Should be populated only for continuous results.	Exp
LBSTRESC	Character Result/Finding in Std Format	Char	(LBSTRESC)	Result Qualifier	Contains the result value for all findings, copied or derived from LBORRES in a standard format or standard units. LBSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in LBSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in LBORRES and these results effectively have the same meaning, they could be represented in standard format in LBSTRESC as "NEGATIVE". For other examples, see general assumptions.	Exp
LBSTRESN	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 LBSTRESC. LBSTRESN should store all numeric test results or findings.	Exp
LBSTRESU	Standard Units	Char	(UNIT)	Variable Qualifier	Standardized unit used for LBSTRESC or LBSTRESN.	Exp
LBSTNRLO	Reference Range Lower Limit-Std Units	Num		Variable Qualifier	Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results.	Exp
LBSTNRHI	Reference Range Upper Limit-Std Units	Num		Variable Qualifier	Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.	Exp
LBSTNRC	Reference Range for Char Rslt-Std Units	Char		Variable Qualifier	For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").	Perm
LBSTREFC	Reference Result in Standard Format	Char		Variable Qualifier	Reference value for the result or finding copied or derived from LBORREF in a standard format.	Exp
LBNRIND	Reference Range Indicator	Char	(NRIND)	Variable Qualifier	Indicates where the value falls with respect to reference range defined by LBORNRLO and LBORNRHI, LBSTNRLO and LBSTNRHI, or by LBSTNRC. Examples: "NORMAL", "ABNORMAL", "HIGH", "LOW". Should not be used to indicate clinical significance.	Exp
LBSTAT	Completion Status	Char	(ND)	Record Qualifier	Used to indicate exam not done. Should be null if a result exists in LBORRES.	Perm
LBREASND	Reason Test Not Done	Char		Record Qualifier	Describes why a measurement or test was not performed, e.g., "BROKEN EQUIPMENT", "SUBJECT REFUSED", or "SPECIMEN LOST". Used in conjunction with LBSTAT when value is "NOT DONE".	Perm
LBNAM	Vendor Name	Char		Record Qualifier	The name or identifier of the laboratory that performed the test.	Perm
LBLOINC	LOINC Code	Char		Synonym Qualifier	Code for the lab test from the LOINC code system.	Perm
LBSPEC	Specimen Type	Char	(SPECTYPE)	Record Qualifier	Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE", "DNA", "RNA".	Perm
LBSPCCND	Specimen Condition	Char	(SPECCOND)	Record Qualifier	Free or standardized text describing the condition of the specimen, e.g., "HEMOLYZED", "ICTERIC", "LIPEMIC".	Perm
LBMETHOD	Method of Test or Examination	Char	(METHOD)	Record Qualifier	Method of the test or examination. Examples: "EIA" (Enzyme Immunoassay), "ELECTROPHORESIS", "DIPSTICK".	Perm
LBLOBXFL	Last Observation Before Exposure Flag	Char	(NY)	Record Qualifier	Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.	Exp
LBFAST	Fasting Status	Char	(NY)	Record Qualifier	Indicator used to identify fasting status such as "Y", "N", "U", or null if not relevant.	Perm
LBTOX	Toxicity	Char		Variable Qualifier	Description of toxicity quantified by LBTOXGR.	Perm
LBTOXGR	Standard Toxicity Grade	Char		Record Qualifier	Records toxicity grade value using a standard toxicity scale (such as the NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not "Grade 2").	Perm
LBLLOQ	Lower Limit of Quantitation	Num		Variable Qualifier	The lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units.	Perm
LBULOQ	Upper Limit of Quantitation	Num		Variable Qualifier	The highest threshold for reliably detecting the result of a specific test in standardized units.	Perm
VISITNUM	Visit Number	Num		Timing	An assigned numeric identifier that aligns to the chronological order of an encounter. Numeric version of VISIT, used for sorting.	Exp
VISIT	Visit Name	Char		Timing	The label for a protocol-defined encounter. May be used in addition to VISITNUM and/or VISITDY.	Perm
VISITDY	Planned Study Day of Visit	Num		Timing	Planned study day of the visit based upon RFSTDTC in Demographics.	Perm
TAETORD	Planned Order of Element within Arm	Num		Timing	Number that gives the planned order of the Element within the Arm.	Perm
EPOCH	Epoch	Char	(EPOCH)	Timing	Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.	Perm
LBDTC	Date/Time of Specimen Collection	Char	ISO 8601 datetime or interval	Timing	Date/time of specimen collection represented in ISO 8601 character format.	Exp
LBENDTC	End Date/Time of Specimen Collection	Char	ISO 8601 datetime or interval	Timing	End date/time of specimen collection represented in ISO 8601 character format.	Perm
LBDY	Study Day of Specimen Collection	Num		Timing	Study day of specimen collection, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.	Perm
LBENDY	Study Day of End of Observation	Num		Timing	Actual study day of end of observation expressed in integer days relative to the applicant-defined RFSTDTC in Demographics.	Perm
LBTPT	Planned Time Point Name	Char		Timing	Text description of time when specimen should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See LBTPTNUM and LBTPTREF. Examples: "Start", "5 min post".	Perm
LBTPTNUM	Planned Time Point Number	Num		Timing	Numerical version of LBTPT to aid in sorting.	Perm
LBELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Planned elapsed time (in ISO 8601) relative to a planned fixed reference (LBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable. Represented as ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by LBTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by LBTPTREF.	Perm
LBTPTREF	Time Point Reference	Char		Timing	Name of the fixed reference point referred to by LBELTM, LBTPTNUM, and LBTPT.	Perm
LBRFTDTC	Date/Time of Reference Time Point	Char SDTM-754 - Getting issue details... STATUS	ISO 8601 datetime or interval	Timing	Date/time of the reference time point, LBTPTREF.	Perm

Assumptions

The LB domain captures laboratory data collected on the CRF or received from a central provider or vendor.
For lab tests that do not have continuous numeric results (e.g., urine protein as measured by dipstick, descriptive tests such as urine color), LBSTNRC could be populated either with normal range values that are a range of character values for an ordinal scale (e.g., “NEGATIVE to TRACE") or a delimited set of values that are considered to be normal (e.g., “YELLOW”, “AMBER”). LBORNRLO, LBORNRHI, LBSTNRLO, and LBSTNRHI should be null for these types of tests.
LBNRIND can be added to indicate where a result falls with respect to reference range defined by LBORNRLO and LBORNRHI. Examples: "HIGH", "LOW". Clinical significance would be represented as a record in SUPPLB with a QNAM of LBCLSIG.
For lab tests where the specimen is collected over time (e.g., 24-hour urine collection), the start date/time of the collection goes into LBDTC and the end date/time of collection goes into LBENDTC.
Any Identifiers, Timing variables, or Findings general-observation class qualifiers may be added to the LB domain, but the following Qualifiers would not generally be used in LB: --BODSYS, --SEV.
A value derived by a central lab according to their procedures is considered collected rather than derived.
The variable LBORRESU uses the UNIT codelist. This means that applicants should be submitting a term from the CDISC Submission Value column in the published Controlled Terminology List (available at https://www.cdisc.org/standards/terminology/controlled-terminology). When applicants have units that are not in this column, they should first check to see if their unit is mathematically synonymous with an existing unit and submit their lab values using that unit. For example, "g/L" and "mg/mL" are mathematically synonymous, but only "g/L" is in the CDISC Unit codelist. If this is not the case, then a New-Term Suggestion form (https://ncitermform.nci.nih.gov/ncitermform/) should be submitted.

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SDTM Laboratory Test Results (LB)