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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 MS STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 MS DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 MS 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 MS NHOID Non-host Organism ID Char Identifier Perm 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.
5 MS MSSEQ Sequence Number Num Identifier Req 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.
6 MS MSGRPID 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 MS MSREFID Reference ID Char Identifier Perm Optional internal or external identifier such as an identifier for the culture/isolate being tested for susceptibility.
8 MS MSSPID 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 MS MSLNKID 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 MS MSTESTCD Short Name of Assessment Char C128688 Topic Req 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.
11 MS MSTEST Name of Assessment Char C128687 Synonym Qualifier Req 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".
12 MS MSTSTDTL Measurement, Test or Examination Detail Char Variable Qualifier Perm Further description of MSTESTCD and MSTEST.
13 MS MSAGENT Agent Name Char Variable Qualifier Exp 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.
14 MS MSMODIFY Modified Reported Name Char Synonym Qualifier Perm If MSAGENT is modified to facilitate coding, then MSMODIFY will contain the modified text.
15 MS MSCONC Agent Concentration Num Variable Qualifier Perm Numeric concentration of agent listed in MSAGENT.
16 MS MSCONCU Agent Concentration Units Char C71620 Variable Qualifier Perm Units for value of the agent concentration listed in MSCONC. Example: "mg/L".
17 MS MSCAT Category Char Grouping Qualifier Perm Used to define a category of MSTEST values.
18 MS MSSCAT Subcategory Char Grouping Qualifier Perm Used to define a further categorization of MSCAT values.
19 MS MSORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected.
20 MS MSORRESU Original Units Char C71620 Variable Qualifier Perm Unit for MSORRES. Examples: "ug/mL".
21 MS MSSTRESC Result or Finding in Standard Format Char Result Qualifier Exp 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".
22 MS MSSTRESN 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 MSSTRESC. MSSTRESN should store all numeric test results or findings.
23 MS MSSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized units used for MSSTRESC and MSSTRESN. Example: "mol/L".
24 MS MSNRIND Normal/Reference Range Indicator Char Variable Qualifier Perm 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".
25 MS MSRESCAT Result Category Char C85495 Variable Qualifier Perm 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.
26 MS MSSTAT Completion Status Char C66789 Record Qualifier Perm 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".
27 MS MSREASND Reason Not Done Char Record Qualifier Perm Reason not done. Used in conjunction with MSSTAT when value is "NOT DONE".
28 MS MSXFN External File Path Char Record Qualifier Perm Filename for an external file.
29 MS MSNAM Laboratory/Vendor Name Char Record Qualifier Perm Name or identifier of the vendor (e.g., laboratory) that provided the test results.
30 MS MSLOINC LOINC Code Char Synonym Qualifier Perm Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable such as a lab test.
31 MS MSSPEC Specimen Material Type Char C78734 Record Qualifier Perm Defines the type of specimen used for a measurement. Examples: "SPUTUM".
32 MS MSSPCCND Specimen Condition Char C78733 Record Qualifier Perm Defines the condition of the specimen. Example: "CLOUDY".
33 MS MSSPCUFL Specimen Usability for the Test Char C66742 Record Qualifier Perm 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.
34 MS MSLOC Location Used for the Measurement Char C74456 Record Qualifier Perm Anatomical location of the subject relevant to the collection of the measurement.
35 MS MSLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
36 MS MSDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
37 MS MSMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method of the test or examination. Examples: "EPSILOMETER", "MACRO BROTH DILUTION".
38 MS MSANMETH Analysis Method Char Record Qualifier Perm 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).
39 MS MSLOBXFL 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.
40 MS MSBLFL Baseline Flag Char C66742 Record Qualifier Perm 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.
41 MS MSFAST Fasting Status Char C66742 Record Qualifier Perm Indicator used to identify fasting status. Valid values include "Y", "N", "U" or null if not relevant.
42 MS MSDRVFL 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.
43 MS MSEVAL Evaluator Char C78735 Record Qualifier Perm 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".
44 MS MSEVALID Evaluator Identifier Char C96777 Variable Qualifier Perm Used to distinguish multiple evaluators with the same role recorded in MSEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2".
45 MS MSACPTFL Accepted Record Flag Char C66742 Record Qualifier Perm 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.
46 MS MSLLOQ Lower Limit of Quantitation Num Variable Qualifier Perm Indicates the lower limit of quantitation for an assay. Units will be those used for MSSTRESU.
47 MS MSULOQ Upper Limit of Quantitation Num Variable Qualifier Perm Indicates the upper limit of quantitation for an assay. Units will be those used for MSSTRESU.
48 MS MSREPNUM Repetition Number Num Record Qualifier Perm 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.
49 MS VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
50 MS VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
51 MS VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of VISIT. Should be an integer.
52 MS 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 in which the specimen was collected.
53 MS EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the specimen was collected.
54 MS MSDTC Date/Time of Collection Char ISO 8601 Timing Perm Collection date and time of an observation.
55 MS MSENDTC End Date/Time of Observation Char ISO 8601 Timing Perm End date/time of the observation.
56 MS MSDY Study Day of Visit/Collection/Exam Num Timing Perm Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
57 MS MSENDY Study Day of End of Observation Num Timing Perm Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
58 MS MSDUR Duration Char ISO 8601 Timing Perm Collected duration of an event, intervention, or finding. Used only if collected on the CRF and not derived.
59 MS MSTPT Planned Time Point Name Char Timing Perm 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.
60 MS MSTPTNUM Planned Time Point Number Num Timing Perm Numeric version of planned time point used in sorting.
61 MS MSELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm 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.
62 MS MSTPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by MSELTM, MSTPTNUM, and MSTPT. Example: "PREVIOUS DOSE".
63 MS MSRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time for a fixed reference time point defined by MSTPTREF.
64 MS MSSTRF Start Relative to Reference Period Char C66728 Timing Perm 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.
65 MS MSENRF End Relative to Reference Period Char C66728 Timing Perm 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.
66 MS MSEVLINT Evaluation Interval Char ISO 8601 Timing Perm 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.
67 MS MSEVINTX Evaluation Interval Text Char Timing Perm 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".
68 MS MSSTRTPT Start Relative to Reference Time Point Char C66728 Timing Perm Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable MSSTTPT.
69 MS MSSTTPT Start Reference Time Point Char Timing Perm 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".
70 MS MSENRTPT End Relative to Reference Time Point Char C66728 Timing Perm Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable MSENTPT.
71 MS MSENTPT End Reference Time Point Char Timing Perm 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".