Final call before we close subscription!
Subscription to input data and programs (including SAS and R) for all the lessons is now offered at 7,500 INR for a few days.
Click here for more details.
Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 MB STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 MB DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 MB 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 MB MBSEQ Sequence Number Num Identifier Req Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 MB MBGRPID Group ID Char Identifier Exp Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. In MB, used to link to findings about organisms which are stored in MS.
6 MB MBREFID Reference ID Char Identifier Perm Internal or external specimen identifier. Example: Specimen ID
7 MB MBSPID 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. Example: ORGANISM IDENTIFIER. For organism identification, MBSPID would remain the same each time the same organism is identified in a new specimen.
8 MB MBTESTCD Microbiology Test or Finding Short Name Char Topic Req Short name of the measurement, test, or finding described in MBTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MBTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). MBTESTCD cannot contain characters other than letters, numbers, or underscores. Examples for GRAM STAIN findings: GMNROD, GMNCOC, GMSQEPCE, GMPMNLOW. Examples for CULTURE PLATE findings: ORGANISM.
9 MB MBTEST Microbiology Test or Finding Name Char Synonym Qualifier Req Verbatim name of the test or examination used to obtain the measurement or finding. The value in MBTEST cannot be longer than 40 characters. Examples: GRAM NEGATIVE RODS, GRAM NEGATIVE COCCI, SQUAMOUS EPITHELIAL CELLS, PMN PER FIELD LOW, ORGANISM PRESENT
10 MB MBCAT Category for Microbiology Finding Char Grouping Qualifier Perm Used to define a category of related records.
11 MB MBSCAT Subcategory for Microbiology Finding Char Grouping Qualifier Perm Used to define a further categorization of MBCAT.
12 MB MBORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the Microbiology measurement or finding as originally received or collected. Examples for GRAM STAIN findings: +3 MODERATE, +2 FEW, <10. Examples for CULTURE PLATE (ORGANISM) findings: KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PNEUMONIAE.
13 MB MBORRESU Original Units Char C71620 Variable Qualifier Perm Original unit for MBORRES. Example: mcg/mL
14 MB MBSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from MBORRES in a standard format or standard units. MBSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in MBSTRESN. For example, if a test has results "+3 MODERATE", "MOD", and "MODERATE" in MBORRES and these results effectively have the same meaning, they could be represented in standard format in MBSTRESC as "MODERATE".
15 MB MBSTRESN 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 MBSTRESC. MBSTRESN should store all numeric test results or findings.
16 MB MBSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized unit used for MBSTRESC and MBSTRESN.
17 MB MBRESCAT Result Category Char Variable Qualifier Exp Used to categorize the result of a finding in a standard format. Example for ORGANISM finding: INFECTING, COLONIZER, CONTAMINANT, or NORMAL FLORA.
18 MB MBSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate Microbiology was not done, or a test was not done. Should be null or have a value of NOT DONE.
19 MB MBREASND Reason Microbiology Not Performed Char Record Qualifier Perm Reason not done. Used in conjunction with MBSTAT when value is NOT DONE. Examples: BROKEN EQUIPMENT or SUBJECT REFUSED.
20 MB MBNAM Vendor Name Char Record Qualifier Perm Name or identifier of the laboratory or vendor who provides the test results.
21 MB MBLOINC LOINC Code Char Synonym Qualifier Perm 1. Dictionary-derived LOINC Code for MBTEST. 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 MB MBSPEC Specimen Type Char C78734 Record Qualifier Perm Defines the type of specimen used for a measurement. Examples: SPUTUM, BLOOD, PUS.
23 MB MBSPCCND Specimen Condition Char C78733 Record Qualifier Perm Free or standardized text describing the condition of the specimen. Example: CONTAMINATED.
24 MB MBLOC Specimen Collection Location Char C74456 Record Qualifier Perm Location relevant to the collection of the measurement. Examples: LUNG, VEIN, ARM, FOOT
25 MB MBMETHOD Method of Test or Examination Char C85492 Record Qualifier Exp Method of the test or examination. Example: GRAM STAIN, MACRO BROTH DILUTION, AGAR DILUTION
26 MB MBBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. The value should be "Y" or null.
27 MB MBDRVFL 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 MBDRVFL=Y, then MBORRES may be null with MBSTRESC and (if numeric) MBSTRESN having the derived value.
28 MB VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
29 MB VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
30 MB VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
31 MB MBDTC Date/Time of Specimen Collection Char ISO 8601 Timing Exp
32 MB MBDY Study Day of MB Specimen Collection Num Timing Perm 1. Study day of the specimen collection, 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.
33 MB MBTPT Planned Time Point Name Char Timing Perm 1. Text Description of time when specimen should be taken. 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See MBTPTNUM and MBTPTREF. Examples: Start, 5 min post.
34 MB MBTPTNUM Planned Time Point Number Num Timing Perm Numerical version of MBTPT to aid in sorting.
35 MB MBELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned elapsed time (in ISO 8601) relative to a planned fixed reference (MBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by MBTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by MBTPTREF.
36 MB MBTPTREF Time Point Reference Char Timing Perm Name of the fixed reference point referred to by MBELTM, MBTPTNUM, and MBTPT. Example: PREVIOUS DOSE.
37 MB MBRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time of the reference time point, MBTPTREF.