SDTM.TU

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 which have been identified.
6	TU	TUREFID	Reference ID	Char		Identifier	Perm	Internal or external identifier. Example: 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 tumors to the assessment results (in TR domain) over the course of the study.
9	TU	TUTESTCD	Tumor Identification 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 contain characters other than letters, numbers, or underscores. Example: TUMIDENT (Tumor Identification). See Assumption 2.
10	TU	TUTEST	Tumor Identification Test Name	Char	C96783	Synonym Qualifier	Req	Verbatim name of the test for the tumor identification. The value in TUTEST cannot be longer than 40 characters. Example: Tumor Identification. See Assumption 2.
11	TU	TUORRES	Tumor Identification Result	Char		Result Qualifier	Exp	Result of the Tumor identification. The result of tumor identification is a classification of identified tumor. Examples: When TUTESTCD=TUMIDENT (Tumor Identification), values of TUORRES might be: TARGET, NON-TARGET, or NEW. or BENIGN ABNORMALITY
12	TU	TUSTRESC	Tumor Identification Result Std. Format	Char	C96780	Record Qualifier	Exp	Contains the result value for all findings copied from TUORRES.
13	TU	TUNAM	Vendor Name	Char		Record Qualifier	Perm	The name or identifier of the vendor that performed the Tumor Identification. This column can be left Null when the Investigator provides the complete set of data in the domain.
14	TU	TULOC	Location of the Tumor	Char	C74456	Record Qualifier	Exp	Used to specify the anatomical location of the identified tumor. Example: 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.
15	TU	TULAT	Laterality	Char	C99073	Record Qualifier	Perm	Qualifier for anatomical location or specimen further detailing laterality, for example, LEFT, RIGHT, BILATERAL.
16	TU	TUDIR	Directionality	Char	C99074	Record Qualifier	Perm	Qualifier for anatomical location or specimen further detailing directionality, for example, UPPER, INTERIOR.
17	TU	TUPORTOT	Portion or Totality	Char	C99075	Record Qualifier	Perm	Qualifier for anatomical location or specimen further detailing the distribution which means arrangement of, or apportioning of, for example, ENTIRE, SINGLE, SEGMENT, MULTIPLE.
18	TU	TUMETHOD	Method of Identification	Char	C85492	Record Qualifier	Exp	Method used to identify the tumor. Examples: MRI, CT SCAN.
19	TU	TUEVAL	Evaluator	Char	C78735	Record Qualifier	Exp	Role of the person who provided the evaluation. Examples: INVESTIGATOR, INDEPENDNT 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 meaning that the rows attributed to the Investigator should contain a value of INVESTIGATOR.
20	TU	TUEVALID	Evaluator Identifier	Char	C96777	Variable Qualifier	Perm	The Evaluator Specified variable is used in conjunction with TUEVAL to provide an additional level of detail. When multiple assessors play the role identified in TUEVAL, values of TUEVALID will attribute a row of data to a particular assessor. TUEVALID should not contain the names of the assessors, or a code identifier for a specific assessor, but should contain values such as RADIOLOGIST, RADIOLOGIST 1 or RADIOLOGIST 2. The TUEVALID variable is subject to CDISC Controlled Terminology. See Assumption 7.
21	TU	TUACPTFL	Accepted Record Flag	Char	C66742	Record Qualifier	Perm	In cases where more than one independent assessor (e.g. RADIOLOGIST 1, RADIOLOGIST 2, ADJUDICATOR) provide independent assessments at the same time point this flag identifies the record that is considered to be the accepted assessment.
22	TU	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
23	TU	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
24	TU	VISITDY	Planned Study Day of Visit	Num		Timing	Perm
25	TU	EPOCH	Epoch	Char		Timing	Perm	Epoch associated with the Element in the planned sequence of Elements for the ARM to which the subject was assigned.
26	TU	TUDTC	Date/Time of Tumor Identification	Char	ISO 8601	Timing	Exp	TUDTC variable represents the date of the scan/image/physical exam not the date that the image was read to identify tumors. TUDTC variable does not represent the VISIT date.
27	TU	TUDY	Study Day of Tumor Identification	Num		Timing	Perm	1. Study day of the scan/image/physical exam, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.