SDTM.TR

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	TR	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	TR	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	TR	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	TR	TRSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness within a dataset for a subject. May be any valid number.
5	TR	TRGRPID	Group ID	Char		Identifier	Perm	Used to link together a block of related records within a subject in a domain.
6	TR	TRREFID	Reference ID	Char		Identifier	Perm	Internal or external identifier.
7	TR	TRSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined identifier.
8	TR	TRLNKID	Link ID	Char		Identifier	Exp	Identifier used to link the assessment result records to the individual tumor identification record in TU domain.
9	TR	TRLNKGRP	Link Group	Char		Identifier	Perm	Used to group and link all of the measurement/assessment records used in the assessment of the response record in the RS domain.
10	TR	TRTESTCD	Tumor Assessment Short Name	Char	C96779	Topic	Req	Short name of the TEST in TRTEST. TRTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: TUMSTATE, DIAMETER. See Assumption 2.
11	TR	TRTEST	Tumor Assessment Test Name	Char	C96778	Synonym Qualifier	Req	Verbatim name of the test or examination used to obtain the measurement or finding. The value in TRTEST cannot be longer than 40 characters. Examples: Tumor State, Diameter, Longest Perpendicular diameter, Volume, Area. See Assumption 2.
12	TR	TRORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the Tumor measurement/assessment as originally received or collected.
13	TR	TRORRESU	Original Units	Char	C71620	Variable Qualifier	Exp	Original units in which the data were collected. The unit for TRORRES. Example: mm
14	TR	TRSTRESC	Character Result/Finding in Std Format	Char		Record Qualifier	Exp	Contains the result value for all findings, copied or derived from TRORRES in a standard format or standard units. TRSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in TRSTRESN
15	TR	TRSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Exp	Used for continuous or numeric results or findings in standard format; copied in numeric format from TRSTRESC. TRSTRESN should store all numeric test results or findings.
16	TR	TRSTRESU	Standard Units	Char	C71620	Variable Qualifier	Exp	Standardized unit used for TRSTRESN.
17	TR	TRSTAT	Completion Status	Char	C66789	Result Qualifier	Perm	Used to indicate a scan/image/physical exam was not performed or a tumor measurement was not taken. Should be Null if a result exists in TRORRES.
18	TR	TRREASND	Reason Tumor Measurement Not Performed	Char		Record Qualifier	Perm	Describes why a scan/image/physical exam was not performed or a tumor measurement was not taken. Examples: SCAN NOT PERFORMED, NOT ASSESSABLE: Image obscured, TUMOR. Used in conjunction with TRSTAT when value is NOT DONE.
19	TR	TRNAM	Vendor Name	Char		Record Qualifier	Perm	The name or identifier of the vendor that performed the Tumor measurement or assessment. This column can be left Null when the Investigator provides the complete set of data in the domain.
20	TR	TRMETHOD	Method used to Identify the Tumor		C85492	Record Qualifier	Exp	Method used to measure the tumor. Examples: MRI, CT SCAN.
21	TR	TREVAL	Evaluator	Char	C78735	Record Qualifier	Exp	Role of the person who provided the evaluation. Examples: INVESTIGATOR, 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 meaning that the rows attributed to the Investigator should contain a value of INVESTIGATOR.
22	TR	TREVALID	Evaluator Identifier	Char	C96777	Variable Qualifier	Perm	The Evaluator Specified variable is used in conjunction with TREVAL to provide an additional level of detail. When multiple assessors play the role identified in TREVAL, values of TREVALID will attribute a row of data to a particular assessor. TREVALID 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 TREVALID variable is subject to CDISC Controlled Terminology. Note TREVAL must also be populated when TREVALID is populated. See Assumption 7.
23	TR	TRACPTFL	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 timepoint this flag identifies the record that is considered to be the accepted assessment.
24	TR	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
25	TR	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
26	TR	VISITDY	Planned Study Day of Visit	Num		Timing	Perm
27	TR	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
28	TR	TRDTC	Date/Time of Tumor Measurement	Char	ISO 8601	Timing	Exp	TRDTC variable represents the date of the scan/image/physical exam not the date that the image was read to identify tumors. TRDTC variable does not represent the VISIT date.
29	TR	TRDY	Study Day of Tumor Measurement	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.