| 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 application or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp |
| POOLID | Pool Identifier | Char |
| Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm |
| LBSEQ | Sequence Number | Num |
| Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req |
| LBGRPID | Group Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the dosing group number. | Perm |
| LBREFID | Specimen Identifier | Char |
| Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm |
| LBSPID | Applicant-Defined Identifier | Char |
| Identifier | Applicant-defined reference identifier. 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 | Long name for LBTESTCD. 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 the lab test performed. Examples: URINALYSIS, CLINICAL CHEMISTRY, HEMATOLOGY, etc. | Exp |
| LBSCAT | Subcategory for Lab Test | Char |
| Grouping Qualifier | A further categorization of a test category. Examples: DIFFERENTIAL, LIVER FUNCTION, ELECTROLYTES. | Perm |
| LBORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp |
| LBORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp |
| LBORNRLO | Reference Range Lower Limit-Orig Unit | Char |
| Variable Qualifier | Lower end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results. | Perm |
| LBORNRHI | Reference Range Upper Limit-Orig Unit | Char |
| Variable Qualifier | Upper end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results. | Perm |
| LBSTRESC | Standardized Result in Character Format | Char |
| 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 submitted 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 | Standardized Result in Numeric Format | Num |
| Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of LBSTRESC. LBSTRESN should store all numeric test results or findings. | Exp |
| LBSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for LBSTRESC and LBSTRESN. | Exp |
| LBSTNRLO | Reference Range Lower Limit-Std Unit | Num |
| Variable Qualifier | Lower end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Perm |
| LBSTNRHI | Reference Range Upper Limit-Std Unit | Num |
| Variable Qualifier | Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Perm |
| LBSTNRC | Reference Range for Char Rslt-Std Unit | 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 |
| LBNRIND | Reference Range Indicator | Char |
| Variable Qualifier | Indicates where value falls with respect to reference range defined by LBORNRLO and LBORNRHI, LBSTRNRLO and LBSTNRHI, or by LBSTNRC. Examples: NORMAL, ABNORMAL, HIGH, LOW.
Applicants should specify in the study metadata (Comments column in the data definition file) whether LBNRIND refers to the original or standard reference ranges and results. Should not be used to indicate biological significance. | Perm |
| LBSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in LBORRES. | Perm |
| LBREASND | Reason Not Done | Char |
| Record Qualifier | Describes why LBSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST. | Perm |
| LBNAM | Laboratory Name | Char |
| Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm |
| LBSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of specimen analyzed to obtain the measurement or finding. Examples: WHOLE BLOOD, SERUM, PLASMA, URINE, LIVER, HEART. | Exp |
| LBANTREG | Anatomical Region of Specimen | Char |
| Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the LBSPEC variable. If the anatomical region is not included in the specimen description LBSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm |
| LBSPCCND | Specimen Condition | Char |
| Record Qualifier | Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC. | Perm |
| LBSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be N if the specimen is not usable; otherwise it should be null. | Perm |
| LBLOC | Specimen Collection Location | Char |
| Record Qualifier | Location relevant to the collection of specimen for the measurement. | Perm |
| LBLAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm |
| LBDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm |
| LBPORTOT | Portion or Totality | Char | (PORTOT) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm |
| LBMETHOD | Method of Test or Examination | Char |
| Record Qualifier | Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK. | Exp |
| LBBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp |
| LBFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. The value should be Y or null. | Perm |
| LBDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. Records that represent the average of other records, or are not as originally received or collected are examples of records that might be derived for the submission datasets. | Perm |
| LBTOX | Toxicity | Char |
| Variable Qualifier | Description of toxicity quantified by LBTOXGR. The applicant is expected to provide the name and version of the scale used to map the terms, utilizing the data definition file external codelist attributes. | 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"). The applicant is expected to provide the name of the scale and version used to map the terms, utilizing the data definition file external codelist attributes. | Perm |
| LBEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm |
| LBREASEX | Reason for Exclusion | Char |
| Record Qualifier | The reason the result should be excluded from all calculations. Used only when LBEXCLFL is "Y". | Perm |
| LBUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the specimen collection was unscheduled. If a specimen collection was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | Exp |
| VISITDY | Planned Study Day of Collection | Num |
| Timing | Planned study day of specimen collection. Should be an integer. | Perm |
| LBDTC | Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of specimen collection, in IS0 8601 format. | Exp |
| LBENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of the end of specimen collection in ISO 8601 format. Should be populated only for continuous sample collection. | Perm |
| LBDY | Study Day of Specimen Collection | Num |
| Timing | Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| LBENDY | Study Day of End of Specimen Collection | Num |
| Timing | Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| LBNOMDY | Nominal Study Day for Tabulations | Num |
| Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp |
| LBNOMLBL | Label for Nominal Study Day | Char |
| Timing | A label for a given value of LBNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac. | 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 | Elapsed time (in ISO 8601 format) 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 an ISO 8601 duration. Examples: "- P15M" to represent the period of 15 minutes prior to the reference point indicated by LBTPTREF, or "P8H" 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, if used for LBTPTNUM, and LBTPT. It is recommended that LBTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: PREVIOUS DOSE, PREVIOUS MEAL. | Perm |
| LBRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, LBTPTREF. | Perm |