| 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 |
| FOCID |
Focus of Study-Specific Interest |
Char |
Identifier |
Identification of a focus of study-specific interest on or
within a subject or specimen as called out in the protocol for which
a measurement, test, or examination was performed.The value in this
variable should have inherent semantic meaning. |
Perm |
| MBSEQ |
Sequence Number |
Num |
Identifier |
Sequence number to ensure uniqueness of records within a
dataset for a subject. May be any valid number. |
Req |
| MBGRPID |
Group ID |
Char |
Identifier |
Optional group identifier, used to link together a block of
related records within a subject in a domain. In SDTMIG v3.2, this
was an Expected variable. In this version, the core designation has
been changed to Permissible. |
Perm |
| MBREFID |
Reference ID |
Char |
Identifier |
Internal or external specimen identifier such as the sample
ID for a subject sample from which a microbial culture was
generated. |
Perm |
| MBSPID |
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. |
Perm |
| MBLNKID |
Link ID |
Char |
Identifier |
Identifier used to link related records across domains. This
may be a one-to-one or a one-to-many relationship. For example, it
may be used to link genetic findings (in the PF domain) about a
microbe to the original culture of that microbe (in MB), or to
susceptibility records (in MS) if needed. |
Perm |
| MBLNKGRP |
Link Group ID |
Char |
Identifier |
Identifier used to link related records across domains. This
will usually be a many-to-one relationship. |
Perm |
| MBTESTCD |
Microbiology Test or Finding Short Name |
Char |
Topic |
Short name of the measurement, test, or finding described in
MBTEST. It can be used as a column name when converting a dataset
from a vertical to a horizontal format. The value in MBTESTCD cannot
be longer than 8 |
Req |
| |
|
|
|
characters, nor can it start with a number (e.g., "1TEST" is
not valid). MBTESTCD cannot contain characters other than letters,
numbers, or underscores. Example: "MCORGIDN" for Microbial Organism
Identification; "GMNCOC" for Gram Negative Cocci. |
|
| MBTEST |
Microbiology Test or Finding Name |
Char |
Synonym Qualifier |
Verbatim name of the test or examination used to obtain the
measurement or finding. The value in MBTEST cannot be longer than 40
characters. Examples:"Microbial Organism Identification; "Gram
Negative Cocci"; "HIV-1 RNA". |
Req |
| MBTSTDTL |
Measurement, Test or Examination Detail |
Char |
Variable Qualifier |
Further description of MBTESTCD and MBTEST. Example: "VIRAL
LOAD" (when MBTESTCD represents viral genetic material, such as
"HCRNA"); "QUANTIFICATION" when MBTESTCD represents any organism
being quantified. |
Perm |
| MBCAT |
Category |
Char |
Grouping Qualifier |
Used to define a category of related records. |
Perm |
| MBSCAT |
Subcategory |
Char |
Grouping Qualifier |
Used to define a further categorization of MBCAT values. |
Perm |
| MBORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the Microbiology measurement or finding as
originally received or collected. Examples for "GRAM STAIN"
findings: "+3 MODERATE", "+2 FEW", "<10". Examples for "CULTURE
PLATE" findings: "KLEBSIELLA PNEUMONIAE", "STREPTOCOCCUS
PNEUMONIAE". |
Exp |
| MBORRESU |
Original Units |
Char |
Variable Qualifier |
Original unit for MBORRES. Example: "mcg/mL". |
Perm |
| MBSTRESC |
Result or Finding in Standard Format |
Char |
Result Qualifier |
Contains the result value for all findings, copied or
derived from MBORRES in a standard format or standard units.
MBSTRESC should store all results or findings in character format;
if results are numeric, they should also be stored in numeric format
in MBSTRESN. For example, if a test has results "+3 MODERATE",
"MOD", and "MODERATE" in MBORRES and these results effectively have
the same meaning, they could be represented in standard format in
MBSTRESC as "MODERATE". |
Exp |
| MBSTRESN |
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 MBSTRESC. MBSTRESN
should store all numeric test results or findings. |
Perm |
| MBSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized units used for MBSTRESC and MBSTRESN. |
Perm |
| MBRESCAT |
Result Category |
Char |
Variable Qualifier |
Used to categorize the result of a finding in a standard
format. In SDTMIG v3.2, this was an Expected variable. In this
version, the core designation has been changed to Permissible. |
Perm |
| MBSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate that a question was not asked or a test was
not done, or that a test was attempted but did not generate a
result. Should be null or have a value of "NOT DONE". |
Perm |
| MBREASND |
Reason Not Done |
Char |
Record Qualifier |
Reason not done. Used in conjunction with MBSTAT when value
is NOT DONE. Examples: "BROKEN EQUIPMENT" or "SUBJECT REFUSED". |
Perm |
| MBNAM |
Laboratory/Vendor Name |
Char |
Record Qualifier |
Name or identifier of the vendor (e.g., laboratory) that
provided the test results. |
Perm |
| MBLOINC |
LOINC Code |
Char |
Synonym Qualifier |
Logical Observation Identifiers Names and Codes (LOINC) code
for the topic variable, such as a lab test. |
Perm |
| MBSPEC |
Specimen Material Type |
Char |
Record Qualifier |
Defines the type of specimen used for a measurement.
Examples: "SPUTUM", "BLOOD", "PUS". |
Perm |
| MBSPCCND |
Specimen Condition |
Char |
Record Qualifier |
Free or standardized text describing the condition of the
specimen. Example: "CONTAMINATED". |
Perm |
| MBLOC |
Specimen Collection Location |
Char |
Record Qualifier |
Anatomical location relevant to the collection of the
measurement. |
Perm |
| MBLAT |
Laterality |
Char |
Variable Qualifier |
Qualifier for specimen collection location further detailing
laterality. Examples: "RIGHT", "LEFT", "BILATERAL". |
Perm |
| MBDIR |
Directionality |
Char |
Variable Qualifier |
Qualifier for specimen collection location further detailing
directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". |
Perm |
| MBMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of the test or examination. Example: "GRAM
STAIN","MICROBIAL CULTURE, LIQUID", "QUANTITATIVE REVERSE
TRANSCRIPTASE POLYMERASE CHAIN REACTION". |
Exp |
| MBLOBXFL |
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. |
Perm |
| MBBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. Should be "Y"
or null. Note that MBBLFL is retained for backward compatibility.
The authoritative baseline for statistical analysis is in an ADaM
dataset. |
Perm |
| MBFAST |
Fasting Status |
Char |
Record Qualifier |
Indicator used to identify fasting status. Valid values
include "Y", "N", "U" or null if not relevant. |
Perm |
| MBDRVFL |
Derived Flag |
Char |
Record Qualifier |
Used to indicate a derived record (e.g., a record that
represents the average of other records such as a computed
baseline). Should be "Y" or null. |
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 a clinical encounter. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of VISIT. Should be an integer. |
Perm |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm for the Element which the specimen collection occurred. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time at which the specimen
was collected. |
Perm |
| MBDTC |
Date/Time of Collection |
Char |
Timing |
Date/time of specimen collection. |
Exp |
| MBDY |
Study Day of Visit/Collection/Exam |
Num |
Timing |
Study day of the 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 |
| MBTPT |
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 MBTPTNUM and MBTPTREF.
Examples: "Start", "5 min post". |
Perm |
| MBTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numeric version of MBTPT used in sorting. |
Perm |
| Name |
|
|
|
|
|
| MBELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
Planned elapsed time (in ISO 8601) relative to a planned
fixed reference (MBTPTREF). 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
MBTPTREF, or "PT8H" to represent the period of 8 hours after the
reference point indicated by MBTPTREF. |
Perm |
| MBTPTREF |
Time Point Reference |
Char |
Timing |
Name of the fixed reference point referred to by MBELTM,
MBTPTNUM, and MBTPT. Example: "PREVIOUS DOSE". |
Perm |
| MBRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time for a fixed reference time point, MBTPTREF. |
Perm |