| 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 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 |
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 |
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 |
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 |
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 |
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 |
Variable Qualifier |
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". 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. 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, 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 |
Code for the lab test from the LOINC code system. 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", "DNA", "RNA". |
Perm |
| LBSPCCND |
Specimen Condition |
Char |
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 |
Record Qualifier |
Method of the test or examination. Examples: "EIA" (Enzyme
Immunoassay), "ELECTROPHORESIS", "DIPSTICK". |
Perm |
| LBLOBXFL |
Last Observation Before Exposure Flag |
Char |
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 |
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 |
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 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 |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
Protocol-defined description of clinical encounter. 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 |
| 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 |
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 |
Timing |
Date/time of specimen collection represented in ISO 8601
character format. |
Exp |
| LBENDTC |
End Date/Time of Specimen Collection |
Char |
Timing |
End date/time of specimen collection represented in ISO 8601
character format. |
Perm |
| LBDY |
Study Day of Specimen Collection |
Num |
Timing |
Study day of specimen collection, measured as integer days.
Algorithm for calculations must be relative to the sponsor-defined
RFSTDTC variable in Demographics. This formula should be consistent
across the submission. |
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 |
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 |
| Name |
|
|
|
|
|
| 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 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 |