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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 MSSEQ Sequence Number Num Identifier Req Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 MS MSGRPID Group ID Char Identifier Req Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. In MS, used to link to organism in MB.
6 MS MSREFID Reference ID Char Identifier Perm Internal or external specimen identifier. Example: Specimen ID.
7 MS MSSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database.
8 MS MSTESTCD Microbiology Organism Finding Short Name Char Topic Req Short name of the measurement, test, or finding described in MSTEST. 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). MSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples for GROWTH findings: EXTGROW, COLCOUNT. For SUSCEPTIBILITY findings, the test is the drug the organism was tested with, i.e. PENICLLN, AMOXCLLN.
9 MS MSTEST Organism Test or Finding Name Char Synonym Qualifier Req Verbatim name of the test or examination used to obtain the measurement or finding. Examples for GROWTH findings: Extent of Growth, Colony Count. Examples for SUSCEPTIBILITY findings: Amoxicillin Susceptibility, Penicillin Susceptibility
10 MS MSCAT Category for Organism Findings Char Grouping Qualifier Req Used to define a category of related records. Examples: GROWTH, SUSCEPTIBILITY.
11 MS MSSCAT Subcategory for Organism Findings Char Grouping Qualifier Perm A further categorization of a test category. Examples: CULTURE, ISOLATE
12 MS MSORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the Microbiology Organism measurement or finding as originally received or collected. Examples for GROWTH findings: GROWTH INTO 3RD QUADRANT. Examples for SUSCEPTIBLITY findings:.0080,.0023
13 MS MSORRESU Original Units Char C71620 Variable Qualifier Exp Original units in which the data were collected. The unit for MSORRES. Example: mcg/mL
14 MS MSSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from MSORRES in a standard format or 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 a test has results "+3 MODERATE", "MOD", and "MODERATE", and in MSORRES and these results effectively have the same meaning, they could be represented in standard format in MSSTRESC as "MODERATE".
15 MS MSSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Exp 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.
16 MS MSSTRESU Standard Units Char C71620 Variable Qualifier Exp Standardized unit used for MSSTRESC and MSSTRESN.
17 MS MSRESCAT Result Category Char C85495 Variable Qualifier Exp Used to categorize the result of a finding in a standard format. Example for SUSCEPTIBILITY finding: SUSCEPTIBLE, INTERMEDIATE, RESISTANT, or UNKNOWN.
18 MS MSSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate a test on an organism was not done, or a test was not performed. Should be null if a result exists in MSORRES or have a value of NOT DONE.
19 MS MSREASND Reason Test Not Done Char Record Qualifier Perm Reason not done. Describes why a measurement or test was not performed. Used in conjunction with MSSTAT when value is NOT DONE. Example: SAMPLE LOST
20 MS MSNAM Vendor Name Char Record Qualifier Perm Name or identifier of the laboratory or vendor that provided the test results.
21 MS MSLOINC LOINC Code Char Synonym Qualifier Perm 1. Dictionary-derived LOINC Code for MSTEST. 2. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes
22 MS MSMETHOD Method of Test or Examination Char C85492 Record Qualifier Exp Method of the test or examination. Example: GRAM STAIN, MACRO BROTH DILUTION, AGAR DILUTION
23 MS MSBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. The value should be "Y" or null.
24 MS MSDRVFL Derived Flag Char C66742 Record Qualifier Perm Used to indicate a derived record. The value should be Y or null. Records that represent the average of other records or some other derivation, and those that do not come from the CRF, are examples of records that would be derived for the submission datasets. If MSDRVFL=Y, then MSORRES may be null, with MSSTRESC and (if numeric) MSSTRESN having the derived value.
25 MS VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
26 MS VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
27 MS VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
28 MS MSDTC Date/Time of Test Char ISO 8601 Timing Perm
29 MS MSDY Study Day of Test Num Timing Perm 1. Study day of the test, 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.
30 MS MSTPT Planned Time Point Name Char Timing Perm 1. Text Description of time when test should be done. 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See MSTPTNUM and MSTPTREF. Examples: Start, 5 min post.
31 MS MSTPTNUM Planned Time Point Number Num Timing Perm Numerical version of MSTPT to aid in sorting.
32 MS MSELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Elapsed time (in ISO 8601) relative to a planned fixed reference (MSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by MSTPTREF, or "P8H" to represent the period of 8 hours after the reference point indicated by MSTPTREF.
33 MS MSTPTREF Time Point Reference Char Timing Perm Name of the fixed reference point referred to by MSELTM, MSTPTNUM, and MSTPT. Example: PREVIOUS DOSE.