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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 MO STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 MO DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 MO 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 MO MOSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 MO MOGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 MO MOREFID Reference ID Char Identifier Perm Internal or external procedure identifier.
7 MO MOSPID 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. Example: Line number from the procedure or test page.
8 MO MOLNKID Link ID Char Identifier Perm Identifier used to link results of a procedure to the procedure performed.
9 MO MOTESTCD Test or Examination Short Name Char Topic Req Short name of the measurement, test, or examination described in MOTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MOTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MOTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "VOLUME", "INTP".
10 MO MOTEST Test or Examination Name Char Synonym Qualifier Req Verbatim name of the test or examination used to obtain the measurement or finding. The value in MOTEST cannot be longer than 40 characters. Examples: "Volume", "Interpretation".
11 MO MOCAT Category for Test Char Grouping Qualifier Perm Used to categorize observations across subjects.
12 MO MOSCAT Subcategory for Test Char Grouping Qualifier Perm A further categorization.
13 MO MOPOS Position of Subject Char C71148 Record Qualifier Perm Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".
14 MO MOORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the procedure measurement or finding as originally received or collected.
15 MO MOORRESU Original Units Char C71620 Variable Qualifier Perm Original units in which the data were collected. The unit for MOORRES.
16 MO MOSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from MOORRES in a standard format or standard units. MOSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in MOSTRESN.
17 MO MOSTRESN 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 MOSTRESC. MOSTRESN should store all numeric test results or findings.
18 MO MOSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized unit used for MOSTRESC or MOSTRESN.
19 MO MOSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate a test was not done, or a measurement was not taken. Should be null if a result exists in MOORRES.
20 MO MOREASND Reason Test Not Performed Char Record Qualifier Perm Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT" or "SUBJECT REFUSED". Used in conjunction with MOSTAT when value is "NOT DONE".
21 MO MOXFN External File Path Char Record Qualifier Perm File path to the external file.
22 MO MONAM Vendor Name Char Record Qualifier Perm Name or identifier of the laboratory or vendor who provided the test results.
23 MO MOLOC Location Used for Measurement Char C74456 Record Qualifier Perm Location relevant to the collection of the measurement. Examples: "BRAIN", "KIDNEY", "LIVER", etc.
24 MO MOLAT Specimen Laterality within Subject Char C99073 Variable Qualifier Perm Qualifier for laterality of the specimen within the subject for paired specimens. Examples: "LEFT", "RIGHT", "BILATERAL".
25 MO MODIR Specimen Directionality within Subject Char C99074 Variable Qualifier Perm Qualifier for directionality of the specimen within the subject. Examples: "DORSAL", "PROXIMAL".
26 MO MOPORTOT Portion or Totality Char C99075 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing the portion of totality which means arrangement of, or apportioning of. Examples: "ENTIRE", "PARTIAL".
27 MO MOMETHOD Method of Procedure Test Char C85492 Record Qualifier Perm Method of the test or examination result.
28 MO MOANMETH Analysis Method Char Record Qualifier Perm Analysis method applied to obtain a summarized result. Example: "STEREOLOGY".
29 MO MOLOBXFL 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.
30 MO MOBLFL Baseline Flag Char C66742 Record Qualifier Exp Indicator used to identify a baseline value. The value should be "Y" or "null". Note that MOBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset.
31 MO MODRVFL 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 that do not come from the CRF, or are not as originally collected or received are examples of records that would be derived for the submission datasets. If MODRVFL = "Y", then MOORRES could be null, and (if numeric) MOSTRESN have the derived value.
32 MO MOEVAL 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). Should be null for records that contain collected or derived data. Examples: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR".
33 MO VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
34 MO VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
35 MO VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
36 MO 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 assessment was made.
37 MO EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the observation was made.
38 MO MODTC Date/Time of Test Char ISO 8601 Timing Exp Date of test.
39 MO MODY Study Day of Test Num Timing Perm 1. Study day of the procedure or test, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.
40 MO MOTPT Planned Time Point Name Char Timing Perm 1. Text Description of time when measurement 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 MOTPTNUM and MOTPTREF. Examples: "Start", "5 min post".
41 MO MOTPTNUM Planned Time Point Number Num Timing Perm Numerical version of MOTPT to aid in sorting.
42 MO MOELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned elapsed time (in ISO 8601) relative to a fixed time point reference (MOTPTREF). 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 MOTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by MOTPTREF.
43 MO MOTPTREF Time Point Reference Char Timing Perm Name of the fixed reference point referred to by MOELTM, MOTPTNUM, and MOTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
44 MO MORFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time of the reference time point, MOTPTREF.