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Metadataspec

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Shareqc_send4tig10_ds

Class	Findings
Domain	LB

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Variable Name	Variable Label	Type

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Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char

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		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

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		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

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		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

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		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

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Identifier

Used to tie together a block of related records in a single domain for a subject or pool. This is not the

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dosing group number.	Perm
LBREFID	Specimen Identifier	Char

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		Identifier	Internal or external specimen identifier. Example: 1009570101.	Perm
LBSPID

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Applicant-Defined Identifier

Char

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Identifier

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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

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		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

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		Grouping Qualifier	A further categorization of a test category. Examples: DIFFERENTIAL, LIVER FUNCTION, ELECTROLYTES.	Perm
LBORRES	Result or Findings as Collected	Char

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		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

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	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

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		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

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		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

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		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

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	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

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		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

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Variable Qualifier

For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g.,

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-1 to +1; NEGATIVE TO TRACE).	Perm
LBNRIND	Reference Range Indicator	Char

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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.

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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

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		Record Qualifier	Describes why LBSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST.	Perm
LBNAM	Laboratory Name	Char

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		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

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		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

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		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

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		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

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		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

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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

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Variable Qualifier

Description of toxicity quantified by LBTOXGR. The

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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

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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

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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

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		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

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		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

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Timing

Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the

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applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm
LBENDY	Study Day of End of Specimen Collection	Num

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Timing

Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the

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applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm
LBNOMDY	Nominal Study Day for Tabulations	Num

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		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

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	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

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		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

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		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

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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

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		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

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