| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
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 pre-printed 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 |
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”). LBTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: ALT, LDH. |
Req |
| LBTEST |
Lab Test or Examination Name |
Char |
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: such as HEMATOLOGY, URINALYSIS, CHEMISTRY. |
Exp |
| LBSCAT |
Subcategory for Lab Test |
Char |
Grouping Qualifier |
A further categorization of a test category such as
DIFFERENTIAL, COAGULATON, 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 |
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 measurements
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 measurements
in original units. Should be populated only for continuous
results. |
Exp |
| LBSTRESC |
Character Result/Finding in Std 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 storedin 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 |
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 |
| LBNRIND |
Reference Range Indicator |
Char |
Variable Qualifier |
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) whether LBNRIND refers to the original or standard reference ranges and results. 3. Should not be used to indicate clinical significance. |
Exp |
| LBSTAT |
Completion Status |
Char |
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 such
as 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 |
1. Dictionary-derived LOINC Code for LBTEST. 2. The
sponsor is expected to provide the dictionary name and version
used to map the terms utilizing the define.xml external codelist
attributes |
Perm |
| LBSPEC |
Specimen Type |
Char |
Record Qualifier |
Defines the type of specimen used for a measurement.
Examples: SERUM, PLASMA, URINE. |
Perm |
| LBSPCCND |
Specimen Condition |
Char |
Record Qualifier |
Free or standardized text describing the condition of the
specimen e.g. HEMOLYZED, ICTERIC, LIPEMIC etc. |
Perm |
| LBMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of the test or examination. Examples: EIA (Enzyme
Immunoassay), ELECTROPHORESIS, DIPSTICK |
Perm |
| LBBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. The value
should be “Y” or null. |
Exp |
| LBFAST |
Fasting Status |
Char |
Record Qualifier |
Indicator used to identify fasting status such as Y, N, U,
or null if not relevant. |
Perm |
| LBDRVFL |
Derived Flag |
Char |
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 define.xml external codelist
attributes. |
Perm |
| LBTOXGR |
Standard Toxicity Grade |
Char |
Variable 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 define.xml external codelist attributes. |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
1. Clinical encounter number. 2. Numeric version of VISIT,
used for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
1. Protocol-defined description of clinical encounter 2.
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 |
| LBDTC |
Date/Time of Specimen Collection |
Char |
Timing |
|
Exp |
| LBENDTC |
End Date/Time of Specimen Collection |
Char |
Timing |
|
Perm |
| LBDY |
Study Day of Specimen Collection |
Num |
Timing |
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. |
Perm |
| LBTPT |
Planned Time Point Name |
Char |
Timing |
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. |
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 |
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 an 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 |
Timing |
Date/time of the reference time point, LBTPTREF. |
Perm |