Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 MB 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 MB 2 DOMAIN Domain Abbreviation Char MB Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 MB 3 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
SDTMIG 3.3 MB 4 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
SDTMIG 3.3 MB 5 MBSEQ Sequence Number Num Identifier Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number. Req
SDTMIG 3.3 MB 6 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
SDTMIG 3.3 MB 7 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
SDTMIG 3.3 MB 8 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
SDTMIG 3.3 MB 9 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
SDTMIG 3.3 MB 10 MBLNKGRP Link Group ID Char Identifier Identifier used to link related records across domains. This will usually be a many-to-one relationship. Perm
SDTMIG 3.3 MB 11 MBTESTCD Microbiology Test or Finding Short Name Char (MBTESTCD) 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 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. Req
SDTMIG 3.3 MB 12 MBTEST Microbiology Test or Finding Name Char (MBTEST) 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
SDTMIG 3.3 MB 13 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
SDTMIG 3.3 MB 14 MBCAT Category Char Grouping Qualifier Used to define a category of related records. Perm
SDTMIG 3.3 MB 15 MBSCAT Subcategory Char Grouping Qualifier Used to define a further categorization of MBCAT values. Perm
SDTMIG 3.3 MB 16 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
SDTMIG 3.3 MB 17 MBORRESU Original Units Char (UNIT) Variable Qualifier Original unit for MBORRES. Example: "mcg/mL". Perm
SDTMIG 3.3 MB 18 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
SDTMIG 3.3 MB 19 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
SDTMIG 3.3 MB 20 MBSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for MBSTRESC and MBSTRESN. Perm
SDTMIG 3.3 MB 21 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
SDTMIG 3.3 MB 22 MBSTAT Completion Status Char (ND) 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
SDTMIG 3.3 MB 23 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
SDTMIG 3.3 MB 24 MBNAM Laboratory/Vendor Name Char Record Qualifier Name or identifier of the vendor (e.g., laboratory) that provided the test results. Perm
SDTMIG 3.3 MB 25 MBLOINC LOINC Code Char Synonym Qualifier Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable, such as a lab test. Perm
SDTMIG 3.3 MB 26 MBSPEC Specimen Material Type Char (SPECTYPE) Record Qualifier Defines the type of specimen used for a measurement. Examples: "SPUTUM", "BLOOD", "PUS". Perm
SDTMIG 3.3 MB 27 MBSPCCND Specimen Condition Char (SPECCOND) Record Qualifier Free or standardized text describing the condition of the specimen. Example: "CONTAMINATED". Perm
SDTMIG 3.3 MB 28 MBLOC Specimen Collection Location Char (LOC) Record Qualifier Anatomical location relevant to the collection of the measurement. Perm
SDTMIG 3.3 MB 29 MBLAT Laterality Char (LAT) Variable Qualifier Qualifier for specimen collection location further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". Perm
SDTMIG 3.3 MB 30 MBDIR Directionality Char (DIR) Variable Qualifier Qualifier for specimen collection location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". Perm
SDTMIG 3.3 MB 31 MBMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. Example: "GRAM STAIN","MICROBIAL CULTURE, LIQUID", "QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION". Exp
SDTMIG 3.3 MB 32 MBLOBXFL 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. Perm
SDTMIG 3.3 MB 33 MBBLFL Baseline Flag Char (NY) 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
SDTMIG 3.3 MB 34 MBFAST Fasting Status Char (NY) Record Qualifier Indicator used to identify fasting status. Valid values include "Y", "N", "U" or null if not relevant. Perm
SDTMIG 3.3 MB 35 MBDRVFL Derived Flag Char (NY) 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
SDTMIG 3.3 MB 36 VISITNUM Visit Number Num Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 MB 37 VISIT Visit Name Char Timing Protocol-defined description of a clinical encounter. Perm
SDTMIG 3.3 MB 38 VISITDY Planned Study Day of Visit Num Timing Planned study day of VISIT. Should be an integer. Perm
SDTMIG 3.3 MB 39 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
SDTMIG 3.3 MB 40 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the specimen was collected. Perm
SDTMIG 3.3 MB 41 MBDTC Date/Time of Collection Char ISO 8601 Timing Date/time of specimen collection. Exp
SDTMIG 3.3 MB 42 MBDY Study Day of Visit/Collection/Exam Num Timing 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. Perm
SDTMIG 3.3 MB 43 MBTPT 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 MBTPTNUM and MBTPTREF. Examples: "Start", "5 min post". Perm
SDTMIG 3.3 MB 44 MBTPTNUM Planned Time Point Number Num Timing Numeric version of MBTPT used in sorting. Perm
SDTMIG 3.3 MB 45 MBELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 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
SDTMIG 3.3 MB 46 MBTPTREF Time Point Reference Char Timing Name of the fixed reference point referred to by MBELTM, MBTPTNUM, and MBTPT. Example: "PREVIOUS DOSE". Perm
SDTMIG 3.3 MB 47 MBRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point, MBTPTREF. Perm