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/lesion 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/Lesion 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", "LESSCIND", "LESRVIND". See TR Assumption 3.
11	TR	TRTEST	Tumor/Lesion 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", "Volume", "Lesion Success Indicator", "Lesion Revascularization Indicator". See TR Assumption 3.
12	TR	TRORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the tumor/lesion 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	C124309	Result 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	Record Qualifier	Perm	Used to indicate a scan/image/physical exam was not performed or a tumor/lesion measurement was not taken. Should be null if a result exists in TRORRES.
18	TR	TRREASND	Reason Not Done	Char		Record Qualifier	Perm	Describes why a scan/image/physical exam was not performed or a tumor/lesion 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	Laboratory/Vendor Name	Char		Record Qualifier	Perm	The name or identifier of the vendor that performed the tumor/lesion 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/Lesion	Char	C85492	Record Qualifier	Exp	Method used to measure the tumor/lesion. Examples: "MRI", "CT SCAN", "Coronary Angiography".
21	TR	TRLOBXFL	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.
22	TR	TRBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	Indicator used to identify a baseline value. Should be "Y" or null. Note that TRBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset.
23	TR	TREVAL	Evaluator	Char	C78735	Record Qualifier	Exp	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".
24	TR	TREVALID	Evaluator Identifier	Char	C96777	Variable Qualifier	Perm	Used to distinguish multiple evaluators with the same role recorded in TREVAL. Examples:" RADIOLOGIST1", "RADIOLOGIST2". See TR Assumption 6.
25	TR	TRACPTFL	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.
26	TR	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
27	TR	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of a clinical encounter.
28	TR	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
29	TR	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Epoch associated with the date/time at which the assessment was made.
30	TR	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the Element in the planned sequence of Elements for the Arm to which the subject was assigned.
31	TR	TRDTC	Date/Time of Tumor/Lesion Measurement	Char	ISO 8601	Timing	Exp	The date of the scan/image/physical exam. TRDTC does not represent the date that the image was read to identify tumors/lesions. TRDTC also does not represent the VISIT date.
32	TR	TRDY	Study Day of Tumor/Lesion Measurement	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.