Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 MS 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 MS 2 DOMAIN Domain Abbreviation Char MS Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 MS 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 MS 4 NHOID Non-host Organism ID Char Identifier Sponsor-defined identifier for a non-host organism which should only be used when the organism is the subject of the TEST. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by a lab (Example: "A/California/7/2009 (H1N1)"). It is not to be used as a qualifier of the result in the record on which it appears. Perm
SDTMIG 3.3 MS 5 MSSEQ Sequence Number Num Identifier Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1. Req
SDTMIG 3.3 MS 6 MSGRPID 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 MS 7 MSREFID Reference ID Char Identifier Optional internal or external identifier such as an identifier for the culture/isolate being tested for susceptibility. Perm
SDTMIG 3.3 MS 8 MSSPID 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 MS 9 MSLNKID 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 MS 10 MSTESTCD Short Name of Assessment Char (MSTESTCD) Topic Short character value for MSTEST used as a column name when converting a dataset from a vertical format to a horizontal format. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "MIC" for Minimum Inhibitory Concentration; "MICROSUS" for Microbial Susceptibility. Req
SDTMIG 3.3 MS 11 MSTEST Name of Assessment Char (MSTEST) Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or finding. The value in MSTEST cannot be longer than 40 characters. Examples: "Minimum Inhibitory Concentration", "Microbial Susceptibility". Req
SDTMIG 3.3 MS 12 MSTSTDTL Measurement, Test or Examination Detail Char Variable Qualifier Further description of MSTESTCD and MSTEST. Perm
SDTMIG 3.3 MS 13 MSAGENT Agent Name Char Variable Qualifier The name of the agent for which resistance is tested. The agent specified may be based on genetic markers or direct phenotypic drug sensitivity testing. Examples: "Penicillin", name of study drug. Exp
SDTMIG 3.3 MS 14 MSMODIFY Modified Reported Name Char Synonym Qualifier If MSAGENT is modified to facilitate coding, then MSMODIFY will contain the modified text. Perm
SDTMIG 3.3 MS 15 MSCONC Agent Concentration Num Variable Qualifier Numeric concentration of agent listed in MSAGENT. Perm
SDTMIG 3.3 MS 16 MSCONCU Agent Concentration Units Char (UNIT) Variable Qualifier Units for value of the agent concentration listed in MSCONC. Example: "mg/L". Perm
SDTMIG 3.3 MS 17 MSCAT Category Char Grouping Qualifier Used to define a category of MSTEST values. Perm
SDTMIG 3.3 MS 18 MSSCAT Subcategory Char Grouping Qualifier Used to define a further categorization of MSCAT values. Perm
SDTMIG 3.3 MS 19 MSORRES Result or Finding in Original Units Char Result Qualifier Result of the measurement or finding as originally received or collected. Exp
SDTMIG 3.3 MS 20 MSORRESU Original Units Char (UNIT) Variable Qualifier Unit for MSORRES. Examples: "ug/mL". Perm
SDTMIG 3.3 MS 21 MSSTRESC Result or Finding in Standard Format Char Result Qualifier Contains the result value for all findings, copied or derived from MSORRES in a standard format or in standard units. MSSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in MSSTRESN. For example, if various tests have results "NONE", "NEG", and "NEGATIVE" in MSORRES and these results effectively have the same meaning, they could be represented in standard format in MSSTRESC as "NEGATIVE". Exp
SDTMIG 3.3 MS 22 MSSTRESN 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 MSSTRESC. MSSTRESN should store all numeric test results or findings. Perm
SDTMIG 3.3 MS 23 MSSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for MSSTRESC and MSSTRESN. Example: "mol/L". Perm
SDTMIG 3.3 MS 24 MSNRIND Normal/Reference Range Indicator Char Variable Qualifier Used to indicate the value is outside the normal range or reference range. May be defined by MSORNRLO and MSORNRHI or other objective criteria. Examples: "Y", "N", "HIGH", "LOW", "NORMAL". "ABNORMAL". Perm
SDTMIG 3.3 MS 25 MSRESCAT Result Category Char (MSRESCAT) Variable Qualifier Used to categorize the result of a finding. In SDTMIG v3.2, MSRESCAT was used to categorize a numeric susceptibility result represented in MSORRES as either "SUSCEPTIBLE", "INTERMEDIATE", or "RESISTANT". However, results from some susceptibility tests may report only a categorical result and not a numeric result. Thus, in order for susceptibility results to be represented consistently, MSRESCAT should no longer be used for this purpose. In this version, the core designation has been changed from Expected to Permissible. Perm
SDTMIG 3.3 MS 26 MSSTAT Completion Status Char (ND) Record Qualifier Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of "NOT DONE". Perm
SDTMIG 3.3 MS 27 MSREASND Reason Not Done Char Record Qualifier Reason not done. Used in conjunction with MSSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 MS 28 MSXFN External File Path Char Record Qualifier Filename for an external file. Perm
SDTMIG 3.3 MS 29 MSNAM Laboratory/Vendor Name Char Record Qualifier Name or identifier of the vendor (e.g., laboratory) that provided the test results. Perm
SDTMIG 3.3 MS 30 MSLOINC 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 MS 31 MSSPEC Specimen Material Type Char (SPECTYPE) Record Qualifier Defines the type of specimen used for a measurement. Examples: "SPUTUM". Perm
SDTMIG 3.3 MS 32 MSSPCCND Specimen Condition Char (SPECCOND) Record Qualifier Defines the condition of the specimen. Example: "CLOUDY". Perm
SDTMIG 3.3 MS 33 MSSPCUFL Specimen Usability for the Test Char (NY) Record Qualifier Describes the usability of the specimen for the test. The value will be "N" if the specimen is not usable, and null if the specimen is usable. Perm
SDTMIG 3.3 MS 34 MSLOC Location Used for the Measurement Char (LOC) Record Qualifier Anatomical location of the subject relevant to the collection of the measurement. Perm
SDTMIG 3.3 MS 35 MSLAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". Perm
SDTMIG 3.3 MS 36 MSDIR Directionality Char (DIR) Variable Qualifier Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". Perm
SDTMIG 3.3 MS 37 MSMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. Examples: "EPSILOMETER", "MACRO BROTH DILUTION". Perm
SDTMIG 3.3 MS 38 MSANMETH Analysis Method Char Record Qualifier Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g. an image or a genetic sequence). Perm
SDTMIG 3.3 MS 39 MSLOBXFL 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 MS 40 MSBLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. Should be "Y" or null. Note that MSBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 MS 41 MSFAST 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 MS 42 MSDRVFL 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 MS 43 MSEVAL Evaluator Char (EVAL) Record Qualifier Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "MICROSCOPIST". Perm
SDTMIG 3.3 MS 44 MSEVALID Evaluator Identifier Char (MEDEVAL) Variable Qualifier Used to distinguish multiple evaluators with the same role recorded in MSEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". Perm
SDTMIG 3.3 MS 45 MSACPTFL Accepted Record Flag Char (NY) Record Qualifier In cases where more than one assessor provides an evaluation of a result or response, this flag identifies the record that is considered, by an independent assessor, to be the accepted evaluation. Expected to be "Y" or null. Perm
SDTMIG 3.3 MS 46 MSLLOQ Lower Limit of Quantitation Num Variable Qualifier Indicates the lower limit of quantitation for an assay. Units will be those used for MSSTRESU. Perm
SDTMIG 3.3 MS 47 MSULOQ Upper Limit of Quantitation Num Variable Qualifier Indicates the upper limit of quantitation for an assay. Units will be those used for MSSTRESU. Perm
SDTMIG 3.3 MS 48 MSREPNUM Repetition Number Num Record Qualifier The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary, e.g., within a time point or within a visit. For example, multiple measurements of blood pressure or multiple analyses of a sample. Perm
SDTMIG 3.3 MS 49 VISITNUM Visit Number Num Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 MS 50 VISIT Visit Name Char Timing Protocol-defined description of a clinical encounter. Perm
SDTMIG 3.3 MS 51 VISITDY Planned Study Day of Visit Num Timing Planned study day of VISIT. Should be an integer. Perm
SDTMIG 3.3 MS 52 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm for the element in which the specimen was collected. Perm
SDTMIG 3.3 MS 53 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the specimen was collected. Perm
SDTMIG 3.3 MS 54 MSDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of an observation. Perm
SDTMIG 3.3 MS 55 MSENDTC End Date/Time of Observation Char ISO 8601 Timing End date/time of the observation. Perm
SDTMIG 3.3 MS 56 MSDY Study Day of Visit/Collection/Exam Num Timing Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 MS 57 MSENDY 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
SDTMIG 3.3 MS 58 MSDUR Duration Char ISO 8601 Timing Collected duration of an event, intervention, or finding. Used only if collected on the CRF and not derived. Perm
SDTMIG 3.3 MS 59 MSTPT Planned Time Point Name Char Timing Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See MSTPTNUM and MSTPTREF. Perm
SDTMIG 3.3 MS 60 MSTPTNUM Planned Time Point Number Num Timing Numeric version of planned time point used in sorting. Perm
SDTMIG 3.3 MS 61 MSELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned Elapsed time relative to a planned fixed reference (MSTPTREF) such as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration. Perm
SDTMIG 3.3 MS 62 MSTPTREF Time Point Reference Char Timing Description of the fixed reference point referred to by MSELTM, MSTPTNUM, and MSTPT. Example: "PREVIOUS DOSE". Perm
SDTMIG 3.3 MS 63 MSRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by MSTPTREF. Perm
SDTMIG 3.3 MS 64 MSSTRF Start Relative to Reference Period Char (STENRF) Timing Identifies the start of the observation as being before, during, or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. Perm
SDTMIG 3.3 MS 65 MSENRF End Relative to Reference Period Char (STENRF) Timing Identifies the end of the observation as being before, during or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. Perm
SDTMIG 3.3 MS 66 MSEVLINT Evaluation Interval Char ISO 8601 Timing Duration of interval associated with an observation such as a finding MSTESTCD. Example: "-P2M" to represent a period of the past 2 months before the assessment. Perm
SDTMIG 3.3 MS 67 MSEVINTX Evaluation Interval Text Char Timing Evaluation interval associated with an observation, where the interval is not able to be represented in ISO 8601 format. Examples: "LIFETIME", "LAST NIGHT", "RECENTLY", "OVER THE LAST FEW WEEKS". Perm
SDTMIG 3.3 MS 68 MSSTRTPT Start Relative to Reference Time Point Char (STENRF) Timing Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable MSSTTPT. Perm
SDTMIG 3.3 MS 69 MSSTTPT Start Reference Time Point Char Timing Description or date/time, in ISO 8601 or other character format, of the sponsor-defined reference point referred to by MSSTRTPT. Examples: "2003-12-15" or "VISIT 1". Perm
SDTMIG 3.3 MS 70 MSENRTPT End Relative to Reference Time Point Char (STENRF) Timing Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable MSENTPT. Perm
SDTMIG 3.3 MS 71 MSENTPT End Reference Time Point Char Timing Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by MSENRTPT. Examples: "2003-12-25" or "VISIT 2". Perm