| 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 |
| 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 |
| 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 |
| 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 |
| MSREFID |
Reference ID |
Char |
Identifier |
Optional internal or external identifier such as an
identifier for the culture/isolate being tested for susceptibility.
|
Perm |
| 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 |
| MSLNKID |
Link ID |
Char |
Identifier |
Identifier used to link related records across domains. This
may be a one-to-one or a one- |
Perm |
| |
|
|
|
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. |
|
| MSTESTCD |
Short Name of Assessment |
Char |
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 |
| MSTEST |
Name of Assessment |
Char |
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 |
| MSTSTDTL |
Measurement, Test or Examination Detail |
Char |
Variable Qualifier |
Further description of MSTESTCD and MSTEST. |
Perm |
| 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 |
| MSMODIFY |
Modified Reported Name |
Char |
Synonym Qualifier |
If MSAGENT is modified to facilitate coding, then MSMODIFY
will contain the modified text. |
Perm |
| MSCONC |
Agent Concentration |
Num |
Variable Qualifier |
Numeric concentration of agent listed in MSAGENT. |
Perm |
| MSCONCU |
Agent Concentration Units |
Char |
Variable Qualifier |
Units for value of the agent concentration listed in MSCONC.
Example: "mg/L". |
Perm |
| MSCAT |
Category |
Char |
Grouping Qualifier |
Used to define a category of MSTEST values. |
Perm |
| MSSCAT |
Subcategory |
Char |
Grouping Qualifier |
Used to define a further categorization of MSCAT values. |
Perm |
| MSORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the measurement or finding as originally received
or collected. |
Exp |
| MSORRESU |
Original Units |
Char |
Variable Qualifier |
Unit for MSORRES. Examples: "ug/mL". |
Perm |
| 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 |
| 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 |
| MSSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized units used for MSSTRESC and MSSTRESN. Example:
"mol/L". |
Perm |
| MSNRIND |
Normal/Reference Range Indicator |
Char |
Variable Qualifier |
Used to indicate the value is outside the normal range or
reference range. May be |
Perm |
| |
|
|
|
defined by MSORNRLO and MSORNRHI or other objective
criteria. Examples: "Y", "N", "HIGH", "LOW", "NORMAL". "ABNORMAL". |
|
| MSRESCAT |
Result Category |
Char |
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 |
| MSSTAT |
Completion Status |
Char |
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 |
| MSREASND |
Reason Not Done |
Char |
Record Qualifier |
Reason not done. Used in conjunction with MSSTAT when value
is "NOT DONE". |
Perm |
| MSXFN |
External File Path |
Char |
Record Qualifier |
Filename for an external file. |
Perm |
| MSNAM |
Laboratory/Vendor Name |
Char |
Record Qualifier |
Name or identifier of the vendor (e.g., laboratory) that
provided the test results. |
Perm |
| MSLOINC |
LOINC Code |
Char |
Synonym Qualifier |
Logical Observation Identifiers Names and Codes (LOINC) code
for the topic variable such as a lab test. |
Perm |
| MSSPEC |
Specimen Material Type |
Char |
Record Qualifier |
Defines the type of specimen used for a measurement.
Examples: "SPUTUM". |
Perm |
| MSSPCCND |
Specimen Condition |
Char |
Record Qualifier |
Defines the condition of the specimen. Example: "CLOUDY". |
Perm |
| MSSPCUFL |
Specimen Usability for the Test |
Char |
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 |
| MSLOC |
Location Used for the Measurement |
Char |
Record Qualifier |
Anatomical location of the subject relevant to the
collection of the measurement. |
Perm |
| MSLAT |
Laterality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". |
Perm |
| MSDIR |
Directionality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
|
Perm |
| MSMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of the test or examination. Examples: "EPSILOMETER",
"MACRO BROTH DILUTION". |
Perm |
| 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 |
| MSLOBXFL |
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 |
| MSBLFL |
Baseline Flag |
Char |
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 |
| MSFAST |
Fasting Status |
Char |
Record Qualifier |
Indicator used to identify fasting status. Valid values
include "Y", "N", "U" or null if not relevant. |
Perm |
| MSDRVFL |
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 |
| MSEVAL |
Evaluator |
Char |
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 |
| MSEVALID |
Evaluator Identifier |
Char |
Variable Qualifier |
Used to distinguish multiple evaluators with the same role
recorded in MSEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". |
Perm |
| MSACPTFL |
Accepted Record Flag |
Char |
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 |
| 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 |
| 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 |
| 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 |
| 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 in which the specimen was collected. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time at which the specimen
was collected. |
Perm |
| MSDTC |
Date/Time of Collection |
Char |
Timing |
Collection date and time of an observation. |
Perm |
| MSENDTC |
End Date/Time of Observation |
Char |
Timing |
End date/time of the observation. |
Perm |
| 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 |
| 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 |
| MSDUR |
Duration |
Char |
Timing |
Collected duration of an event, intervention, or finding.
Used only if collected on the CRF and not derived. |
Perm |
| 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 |
| MSTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numeric version of planned time point used in sorting. |
Perm |
| MSELTM |
Planned Elapsed Time from Time Point Ref |
Char |
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 |
| MSTPTREF |
Time Point Reference |
Char |
Timing |
Description of the fixed reference point referred to by
MSELTM, MSTPTNUM, and MSTPT. Example: "PREVIOUS DOSE". |
Perm |
| MSRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time for a fixed reference time point defined by
MSTPTREF. |
Perm |
| MSSTRF |
Start Relative to Reference Period |
Char |
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 |
| MSENRF |
End Relative to Reference Period |
Char |
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 |
| MSEVLINT |
Evaluation Interval |
Char |
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 |
| 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 |
| MSSTRTPT |
Start Relative to Reference Time Point |
Char |
Timing |
Identifies the start of the observation as being before or
after the sponsor-defined reference time point defined by variable
MSSTTPT. |
Perm |
| 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 |
| MSENRTPT |
End Relative to Reference Time Point |
Char |
Timing |
Identifies the end of the observation as being before or
after the sponsor-defined reference time point defined by variable
MSENTPT. |
Perm |
| 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 |