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SDTMIG v3.3 Metadata Check for Domain Specification Table 1.3.1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. <a href="https://wiki.cdisc.org/x/r37dAg" target="_blank">Release Notes</a>
| Variable Name | Variable Label | Type | Controlled Terms, Codelist or Format1 | 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 | Sponsor-Defined Identifier | Char | Identifier | 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. | 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 |
| 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 |
| 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 |
| LBBLFL | Baseline Flag | Char | (NY) | Record Qualifier | 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. | Perm |
| LBFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status such as "Y", "N", "U", or null if not relevant. | 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 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. | Perm |
| LBTOX | Toxicity | Char | * | Variable Qualifier | 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. | 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 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. | Perm |
| VISITNUM | Visit Number | Num | Timing |
| Exp | |
| VISIT | Visit Name | Char | Timing |
| 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 | Timing | Date/time of specimen collection represented in ISO 8601 character format. | Exp |
| LBENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 | Timing | End date/time of specimen collection represented in ISO 8601 character format. | Perm |
| LBDY | Study Day of Specimen Collection | Num | Timing |
| Perm | |
| LBENDY | Study Day of End of Observation | Num | Timing | Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. | Perm | |
| LBTPT | Planned Time Point Name | Char | Timing |
| 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 | 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. Examples: PREVIOUS DOSE, PREVIOUS MEAL. | Perm | |
| LBRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/time of the reference time point, LBTPTREF. | Perm |
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