| 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 |
| MSSEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| MSGRPID | Group ID | Char | Identifier | 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. | Req |
| MSREFID |
Reference ID |
Char |
Identifier |
Internal or external specimen identifier. Example:
Specimen ID. |
Perm |
| MSSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. | Perm |
| MSTESTCD |
Microbiology Organism Finding Short Name |
Char |
Topic |
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. |
Req |
| MSTEST | Organism Test or Finding Name | Char | Synonym Qualifier | | Req |
| MSCAT |
Category for Organism Findings |
Char |
Grouping Qualifier |
Used to define a category of related records. Examples:
GROWTH, SUSCEPTIBILITY. |
Req |
| MSSCAT |
Subcategory for Organism Findings |
Char |
Grouping Qualifier |
A further categorization of a test category. Examples:
CULTURE, ISOLATE |
Perm |
| MSORRES | Result or Finding in Original Units | Char | Result Qualifier | 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 | Exp |
| MSORRESU |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. The unit
for MSORRES. Example: mcg/mL |
Exp |
| MSSTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
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”. |
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. | Exp |
| MSSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized unit used for MSSTRESC and MSSTRESN. |
Exp |
| MSRESCAT | Result Category | Char | Variable Qualifier | Used to categorize the result of a finding in a standard format. Example for SUSCEPTIBILITY finding: SUSCEPTIBLE, INTERMEDIATE, RESISTANT, or UNKNOWN. | Exp |
| MSSTAT | Completion Status | Char | Record Qualifier | 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. | Perm |
| MSREASND | Reason Test Not Done | Char | Record Qualifier | 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 | Perm |
| MSNAM |
Vendor Name |
Char |
Record Qualifier |
Name or identifier of the laboratory or vendor that
provided the test results. |
Perm |
| MSLOINC | LOINC Code | Char | Synonym Qualifier | 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 | Perm |
| MSMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of the test or examination. Example: GRAM STAIN,
MACRO BROTH DILUTION, AGAR DILUTION |
Exp |
| MSBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. The value
should be “Y” or null. |
Perm |
| MSDRVFL |
Derived Flag |
Char |
Record Qualifier |
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. |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
1. Clinical encounter number. 2. Numeric version of VISIT,
used for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
1. Protocol-defined description of clinical encounter. 2.
May be used in addition to VISITNUM and/or VISITDY. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. |
Perm |
| MSDTC |
Date/Time of Test |
Char |
Timing |
|
Perm |
| MSDY | Study Day of Test | Num | Timing | 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. | Perm |
| MSTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numerical version of MSTPT to aid in sorting. |
Perm |
| MSELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
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. |
Perm |
| MSTPTREF |
Time Point Reference |
Char |
Timing |
Name of the fixed reference point referred to by MSELTM,
MSTPTNUM, and MSTPT. Example: PREVIOUS DOSE. |
Perm |