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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 MB STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 MB DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 MB USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 MB FOCID Focus of Study-Specific Interest Char Identifier Perm 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.
5 MB MBSEQ Sequence Number Num Identifier Req Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number.
6 MB MBGRPID Group ID Char Identifier Perm 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.
7 MB MBREFID Reference ID Char Identifier Perm Internal or external specimen identifier such as the sample ID for a subject sample from which a microbial culture was generated.
8 MB MBSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database.
9 MB MBLNKID Link ID Char Identifier Perm 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.
10 MB MBLNKGRP Link Group ID Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
11 MB MBTESTCD Microbiology Test or Finding Short Name Char C120527 Topic Req 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 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.
12 MB MBTEST Microbiology Test or Finding Name Char C120528 Synonym Qualifier Req 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".
13 MB MBTSTDTL Measurement, Test or Examination Detail Char Variable Qualifier Perm 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.
14 MB MBCAT Category Char Grouping Qualifier Perm Used to define a category of related records.
15 MB MBSCAT Subcategory Char Grouping Qualifier Perm Used to define a further categorization of MBCAT values.
16 MB MBORRES Result or Finding in Original Units Char Result Qualifier Exp 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".
17 MB MBORRESU Original Units Char C71620 Variable Qualifier Perm Original unit for MBORRES. Example: "mcg/mL".
18 MB MBSTRESC Result or Finding in Standard Format Char Result Qualifier Exp 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".
19 MB MBSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Perm 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.
20 MB MBSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized units used for MBSTRESC and MBSTRESN.
21 MB MBRESCAT Result Category Char Variable Qualifier Perm 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.
22 MB MBSTAT Completion Status Char C66789 Record Qualifier Perm 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".
23 MB MBREASND Reason Not Done Char Record Qualifier Perm Reason not done. Used in conjunction with MBSTAT when value is NOT DONE. Examples: "BROKEN EQUIPMENT" or "SUBJECT REFUSED".
24 MB MBNAM Laboratory/Vendor Name Char Record Qualifier Perm Name or identifier of the vendor (e.g., laboratory) that provided the test results.
25 MB MBLOINC LOINC Code Char Synonym Qualifier Perm Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable, such as a lab test.
26 MB MBSPEC Specimen Material Type Char C78734 Record Qualifier Perm Defines the type of specimen used for a measurement. Examples: "SPUTUM", "BLOOD", "PUS".
27 MB MBSPCCND Specimen Condition Char C78733 Record Qualifier Perm Free or standardized text describing the condition of the specimen. Example: "CONTAMINATED".
28 MB MBLOC Specimen Collection Location Char C74456 Record Qualifier Perm Anatomical location relevant to the collection of the measurement.
29 MB MBLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for specimen collection location further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
30 MB MBDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for specimen collection location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
31 MB MBMETHOD Method of Test or Examination Char C85492 Record Qualifier Exp Method of the test or examination. Example: "GRAM STAIN","MICROBIAL CULTURE, LIQUID", "QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION".
32 MB MBLOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Perm Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
33 MB MBBLFL Baseline Flag Char C66742 Record Qualifier Perm 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.
34 MB MBFAST Fasting Status Char C66742 Record Qualifier Perm Indicator used to identify fasting status. Valid values include "Y", "N", "U" or null if not relevant.
35 MB MBDRVFL Derived Flag Char C66742 Record Qualifier Perm 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.
36 MB VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
37 MB VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
38 MB VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of VISIT. Should be an integer.
39 MB TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm for the Element which the specimen collection occurred.
40 MB EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the specimen was collected.
41 MB MBDTC Date/Time of Collection Char ISO 8601 Timing Exp Date/time of specimen collection.
42 MB MBDY Study Day of Visit/Collection/Exam Num Timing Perm 1. Study day of the 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.
43 MB MBTPT Planned Time Point Name Char Timing Perm 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 MBTPTNUM and MBTPTREF. Examples: "Start", "5 min post".
44 MB MBTPTNUM Planned Time Point Number Num Timing Perm Numeric version of MBTPT used in sorting.
45 MB MBELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm 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.
46 MB MBTPTREF Time Point Reference Char Timing Perm Name of the fixed reference point referred to by MBELTM, MBTPTNUM, and MBTPT. Example: "PREVIOUS DOSE".
47 MB MBRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time for a fixed reference time point, MBTPTREF.