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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 UR STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 UR DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 UR 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 UR URSEQ Sequence Number Num Identifier Req Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number (including decimals) and does not have to start at 1.
5 UR URGRPID Group ID Char Identifier Perm Optional group identifier, used to link together a block of related records within a subject in a domain.
6 UR URREFID Reference ID Char Identifier Perm Optional internal or external identifier (e.g., lab specimen ID, universally unique identifier (UUID) for a medical image).
7 UR URSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier. Example: Preprinted line identifier.
8 UR URLNKID Link ID Char Identifier Perm Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
9 UR URLNKGRP Link Group ID Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
10 UR URTESTCD Short Name of Urinary Test Char C129942 Topic Req Short character value for URTEST 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 URTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). URTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "COUNT", "LENGTH", "RBLDFLW".
11 UR URTEST Name of Urinary Test Char C129941 Synonym Qualifier Req Long name For URTESTCD. Examples: "Count", "Length", "Renal Blood Flow".
12 UR URTSTDTL Urinary Test Detail Char Variable Qualifier Perm Further description of URTESTCD and URTEST.
13 UR URCAT Category for Urinary Test Char Grouping Qualifier Perm Used to define a category of topic-variable values.
14 UR URSCAT Subcategory for Urinary Test Char Grouping Qualifier Perm Used to define a further categorization of URCAT values.
15 UR URORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected.
16 UR URORRESU Original Units Char C71620 Variable Qualifier Perm Unit for URORRES.
17 UR URSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings copied or derived from URORRES, in a standard format or in standard units. URSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in URSTRESN.
18 UR URSTRESN 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 URSTRESC. URSTRESN should store all numeric test results or findings.
19 UR URSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized units used for URSTRESC and URSTRESN.
20 UR URRESCAT Result Category Char Variable Qualifier Perm Used to categorize the result of a finding.
21 UR URSTAT Completion Status Char C66789 Record Qualifier Perm 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".
22 UR URREASND Reason Not Done Char Record Qualifier Perm Reason not done. Used in conjunction with URSTAT when value is "NOT DONE".
23 UR URLOC Location Used for the Measurement Char C74456 Record Qualifier Perm Anatomical location of the subject relevant to the collection of the measurement.
24 UR URLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
25 UR URDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
26 UR URMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method of the test or examination.
27 UR URLOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Exp Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
28 UR URBLFL Baseline Flag Char C66742 Record Qualifier Perm A baseline defined by the sponsor The value should be "Y" or null. Note that URBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset.
29 UR URDRVFL Derived Flag Char C66742 Record Qualifier Perm 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.
30 UR UREVAL 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). Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "RADIOLOGIST".
31 UR UREVALID Evaluator Identifier Char C96777 Variable Qualifier Perm Used to distinguish multiple evaluators with the same role recorded in UREVAL. Examples: "RADIOLOGIST1", "RADIOLOGIST2".
32 UR VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
33 UR VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
34 UR VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of VISIT. Should be an integer.
35 UR 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 observation was made.
36 UR EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the observation was made.
37 UR URDTC Date/Time of Collection Char ISO 8601 datetime or interval Timing Exp Collection date and time of an observation.
38 UR URDY Study Day of Visit/Collection/Exam Num Timing Perm Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
39 UR URTPT Planned Time Point Name Char Timing Perm 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 (e.g., time of last dose). See URTPTNUM and URTPTREF.
40 UR URTPTNUM Planned Time Point Number Num Timing Perm Numeric version of planned time point used in sorting.
41 UR URELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 duration Timing Perm Planned elapsed time relative to a planned fixed reference (URTPTREF; e.g., "PREVIOUS DOSE", "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.
42 UR URTPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by URELTM, URTPTNUM, and URTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
43 UR URRFTDTC Date/Time of Reference Time Point Char ISO 8601 datetime or interval Timing Perm Date/time for a fixed reference time point defined by URTPTREF.