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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 TU STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 TU DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 TU 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 TU TUSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness within a dataset for a subject. May be any valid number.
5 TU TUGRPID Group ID Char Identifier Perm Used to link together a block of related records within a subject in a domain. Can be used to group split or merged tumors/lesions which have been identified.
6 TU TUREFID Reference ID Char Identifier Perm Internal or external identifier, such as a medical image ID number.
7 TU TUSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier.
8 TU TULNKID Link ID Char Identifier Exp Identifier used to link identified tumor/lesion to the assessment results (in TR domain) over the course of the study.
9 TU TULNKGRP Link Group ID Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
10 TU TUTESTCD Tumor/Lesion ID Short Name Char C96784 Topic Req Short name of the TEST in TUTEST. TUTESTCD cannot be longer than 8 characters nor can start with a number. TUTESTCD cannot contain characters other than letters, numbers, or underscores. Example: "TUMIDENT". See TU Assumption 3.
11 TU TUTEST Tumor/Lesion ID Test Name Char C96783 Synonym Qualifier Req Verbatim name of the test for the tumor/lesion identification. The value in TUTEST cannot be longer than 40 characters. Example: "Tumor Identification". See TU Assumption 3.
12 TU TUORRES Tumor/Lesion ID Result Char Result Qualifier Exp Result of the tumor/lesion identification. The result of tumor/lesion identification is a classification of the identified tumor/lesion. Examples: When TUTESTCD = "TUMIDENT", values of TUORRES might be "TARGET", "NON-TARGET", "NEW", or "BENIGN ABNORMALITY".
13 TU TUSTRESC Tumor/Lesion ID Result Std. Format Char C123650 Result Qualifier Exp Contains the result value for all findings copied or derived from TUORRES in a standard format.
14 TU TUNAM Laboratory/Vendor Name Char Record Qualifier Perm The name or identifier of the vendor that performed the tumor/lesion Identification. This column can be left null when the investigator provides the complete set of data in the domain.
15 TU TULOC Location of the Tumor/Lesion Char C74456 Record Qualifier Exp Used to specify the anatomical location of the identified tumor/lesion, e.g., "LIVER" Note: When anatomical location is broken down and collected as distinct pieces of data that when combined provide the overall location information (e.g., laterality/directionality/distribution), then the additional anatomical location qualifiers should be used. See Assumption 3.
16 TU TULAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing laterality, for example, "LEFT", "RIGHT", "BILATERAL".
17 TU TUDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing directionality, for example, "UPPER", "INTERIOR".
18 TU TUPORTOT Portion or Totality Char C99075 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, or apportioning of. Examples: "ENTIRE", "SINGLE", "SEGMENT", "MULTIPLE".
19 TU TUMETHOD Method of Identification Char C85492 Record Qualifier Exp Method used to identify the tumor/lesion. Examples: "MRI", "CT SCAN".
20 TU TULOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Exp Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null.
21 TU TUBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. Should be "Y" or null. Note that TUBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset.
22 TU TUEVAL Evaluator Char C78735 Record Qualifier Exp Role of the person who provided the evaluation. Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR". This column can be left null when the investigator provides the complete set of data in the domain. However, the column should contain no null values when data from one or more independent assessors is included. For example, the rows attributed to the investigator should contain a value of "INVESTIGATOR".
23 TU TUEVALID Evaluator Identifier Char C96777 Variable Qualifier Perm Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: "RADIOLOGIST1", "RADIOLOGIST2". See TU Assumption 8.
24 TU TUACPTFL Accepted Record Flag Char C66742 Record Qualifier Perm In cases where more than one independent assessor (e.g., "RADIOLOGIST 1", "RADIOLOGIST 2", "ADJUDICATION COMMITTEE") provide independent assessments at the same time point, this flag identifies the record that is considered to be the accepted assessment.
25 TU VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
26 TU VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
27 TU VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics. Should be an integer.
28 TU 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.
29 TU EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the assessment was made.
30 TU TUDTC Date/Time of Tumor/Lesion Identification Char ISO 8601 Timing Exp TUDTC variable represents the date of the scan/image/physical exam. TUDTC does not represent the date that the image was read to identify tumors. TUDTC also does not represent the VISIT date.
31 TU TUDY Study Day of Tumor/Lesion Identification Num Timing Perm Study day of the scan/image/physical exam, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.