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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 LB STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 LB DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 LB USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 LB LBSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 LB LBGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 LB LBREFID Specimen ID Char Identifier Perm Internal or external specimen identifier. Example: Specimen ID.
7 LB LBSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on the Lab page.
8 LB LBTESTCD Lab Test or Examination Short Name. Char C65047 Topic Req 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".
9 LB LBTEST Lab Test or Examination Name Char C67154 Synonym Qualifier Req 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".
10 LB LBCAT Category for Lab Test Char Grouping Qualifier Exp Used to define a category of related records across subjects. Examples: "HEMATOLOGY", "URINALYSIS", "CHEMISTRY".
11 LB LBSCAT Subcategory for Lab Test Char Grouping Qualifier Perm A further categorization of a test category such as "DIFFERENTIAL", "COAGULATION", "LIVER FUNCTION", "ELECTROLYTES".
12 LB LBORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected.
13 LB LBORRESU Original Units Char C71620 Variable Qualifier Exp Original units in which the data were collected. The unit for LBORRES. Example: "g/L".
14 LB LBORNRLO Reference Range Lower Limit in Orig Unit Char Variable Qualifier Exp Lower end of reference range for continuous measurement in original units. Should be populated only for continuous results.
15 LB LBORNRHI Reference Range Upper Limit in Orig Unit Char Variable Qualifier Exp Upper end of reference range for continuous measurement in original units. Should be populated only for continuous results.
16 LB LBSTRESC Character Result/Finding in Std Format Char C102580 Result Qualifier Exp 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.
17 LB LBSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Exp 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.
18 LB LBSTRESU Standard Units Char C71620 Variable Qualifier Exp Standardized unit used for LBSTRESC or LBSTRESN.
19 LB LBSTNRLO Reference Range Lower Limit-Std Units Num Variable Qualifier Exp Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results.
20 LB LBSTNRHI Reference Range Upper Limit-Std Units Num Variable Qualifier Exp Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.
21 LB LBSTNRC Reference Range for Char Rslt-Std Units Char Variable Qualifier Perm For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").
22 LB LBSTREFC Reference Result in Standard Format Char Variable Qualifier Exp Reference value for the result or finding copied or derived from LBORREF in a standard format.
23 LB LBNRIND Reference Range Indicator Char C78736 Variable Qualifier Exp 1. 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". 2. Sponsors should specify in the study metadata (Comments column in the Define-XML document) whether LBNRIND refers to the original or standard reference ranges and results. 3. Should not be used to indicate clinical significance.
24 LB LBSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate exam not done. Should be null if a result exists in LBORRES.
25 LB LBREASND Reason Test Not Done Char Record Qualifier Perm 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".
26 LB LBNAM Vendor Name Char Record Qualifier Perm The name or identifier of the laboratory that performed the test.
27 LB LBLOINC LOINC Code Char Synonym Qualifier Perm 1. Code for the lab test from the LOINC code system. 2. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes.
28 LB LBSPEC Specimen Type Char C78734 Record Qualifier Perm Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE", "DNA", "RNA".
29 LB LBSPCCND Specimen Condition Char C78733 Record Qualifier Perm Free or standardized text describing the condition of the specimen, e.g., "HEMOLYZED", "ICTERIC", "LIPEMIC".
30 LB LBMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method of the test or examination. Examples: "EIA" (Enzyme Immunoassay), "ELECTROPHORESIS", "DIPSTICK".
31 LB LBLOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Exp Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
32 LB LBBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. Should be "Y" or null. Note that LBBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.
33 LB LBFAST Fasting Status Char C66742 Record Qualifier Perm Indicator used to identify fasting status such as "Y", "N", "U", or null if not relevant.
34 LB LBDRVFL Derived Flag Char C66742 Record Qualifier Perm Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records, or do not come from the CRF, or are not as originally received or collected are examples of records that might be derived for the submission datasets. If LBDRVFL = "Y", then LBORRES may be null, with LBSTRESC and (if numeric) LBSTRESN having the derived value.
35 LB LBTOX Toxicity Char Variable Qualifier Perm Description of toxicity quantified by LBTOXGR. The sponsor is expected to provide the name of the scale and version used to map the terms, utilizing the external codelist element in the Define-XML document.
36 LB LBTOXGR Standard Toxicity Grade Char Record Qualifier Perm 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"). The sponsor is expected to provide the name of the scale and version used to map the terms, utilizing the external codelist element in the Define-XML document.
37 LB VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
38 LB VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
39 LB VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
40 LB TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm.
41 LB EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.
42 LB LBDTC Date/Time of Specimen Collection Char ISO 8601 Timing Exp Date/time of specimen collection represented in ISO 8601 character format.
43 LB LBENDTC End Date/Time of Specimen Collection Char ISO 8601 Timing Perm End date/time of specimen collection represented in ISO 8601 character format.
44 LB LBDY Study Day of Specimen Collection Num Timing Perm 1. Study day of specimen collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
45 LB LBENDY Study Day of End of Observation Num Timing Perm Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
46 LB LBTPT Planned Time Point Name Char Timing Perm 1. Text description of time when specimen should be taken. 2. 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".
47 LB LBTPTNUM Planned Time Point Number Num Timing Perm Numerical version of LBTPT to aid in sorting.
48 LB LBELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm 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.
49 LB LBTPTREF Time Point Reference Char Timing Perm Name of the fixed reference point referred to by LBELTM, LBTPTNUM, and LBTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.
50 LB LBRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time of the reference time point, LBTPTREF.