|
SDTMIG 3.3 |
TR |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
TR |
2 |
DOMAIN |
Domain Abbreviation |
Char |
TR |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
SDTMIG 3.3 |
TR |
3 |
USUBJID |
Unique Subject Identifier |
Char |
|
Identifier |
Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. |
Req |
|
SDTMIG 3.3 |
TR |
4 |
TRSEQ |
Sequence Number |
Num |
|
Identifier |
Sequence number given to ensure uniqueness within a dataset for a subject. May be any valid number. |
Req |
|
SDTMIG 3.3 |
TR |
5 |
TRGRPID |
Group ID |
Char |
|
Identifier |
Used to link together a block of related records within a subject in a domain. |
Perm |
|
SDTMIG 3.3 |
TR |
6 |
TRREFID |
Reference ID |
Char |
|
Identifier |
Internal or external identifier. |
Perm |
|
SDTMIG 3.3 |
TR |
7 |
TRSPID |
Sponsor-Defined Identifier |
Char |
|
Identifier |
Sponsor-defined identifier. |
Perm |
|
SDTMIG 3.3 |
TR |
8 |
TRLNKID |
Link ID |
Char |
|
Identifier |
Identifier used to link the assessment result records to the individual tumor/lesion identification record in TU domain. |
Exp |
|
SDTMIG 3.3 |
TR |
9 |
TRLNKGRP |
Link Group |
Char |
|
Identifier |
Used to group and link all of the measurement/assessment records used in the assessment of the response record in the RS domain. |
Perm |
|
SDTMIG 3.3 |
TR |
10 |
TRTESTCD |
Tumor/Lesion Assessment Short Name |
Char |
(TRTESTCD) |
Topic |
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. |
Req |
|
SDTMIG 3.3 |
TR |
11 |
TRTEST |
Tumor/Lesion Assessment Test Name |
Char |
(TRTEST) |
Synonym Qualifier |
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. |
Req |
|
SDTMIG 3.3 |
TR |
12 |
TRORRES |
Result or Finding in Original Units |
Char |
|
Result Qualifier |
Result of the tumor/lesion measurement/assessment as originally received or collected. |
Exp |
|
SDTMIG 3.3 |
TR |
13 |
TRORRESU |
Original Units |
Char |
(UNIT) |
Variable Qualifier |
Original units in which the data were collected. The unit for TRORRES. Example: "mm". |
Exp |
|
SDTMIG 3.3 |
TR |
14 |
TRSTRESC |
Character Result/Finding in Std Format |
Char |
(TRPROPRS) |
Result Qualifier |
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. |
Exp |
|
SDTMIG 3.3 |
TR |
15 |
TRSTRESN |
Numeric Result/Finding in Standard Units |
Num |
|
Result Qualifier |
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. |
Exp |
|
SDTMIG 3.3 |
TR |
16 |
TRSTRESU |
Standard Units |
Char |
(UNIT) |
Variable Qualifier |
Standardized unit used for TRSTRESN. |
Exp |
|
SDTMIG 3.3 |
TR |
17 |
TRSTAT |
Completion Status |
Char |
(ND) |
Record Qualifier |
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. |
Perm |
|
SDTMIG 3.3 |
TR |
18 |
TRREASND |
Reason Not Done |
Char |
|
Record Qualifier |
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". |
Perm |
|
SDTMIG 3.3 |
TR |
19 |
TRNAM |
Laboratory/Vendor Name |
Char |
|
Record Qualifier |
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. |
Perm |
|
SDTMIG 3.3 |
TR |
20 |
TRMETHOD |
Method Used to Identify the Tumor/Lesion |
Char |
(METHOD) |
Record Qualifier |
Method used to measure the tumor/lesion. Examples: "MRI", "CT SCAN", "Coronary Angiography". |
Exp |
|
SDTMIG 3.3 |
TR |
21 |
TRLOBXFL |
Last Observation Before Exposure Flag |
Char |
(NY) |
Record Qualifier |
Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null. |
Exp |
|
SDTMIG 3.3 |
TR |
22 |
TRBLFL |
Baseline Flag |
Char |
(NY) |
Record Qualifier |
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. |
Perm |
|
SDTMIG 3.3 |
TR |
23 |
TREVAL |
Evaluator |
Char |
(EVAL) |
Record Qualifier |
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". |
Exp |
|
SDTMIG 3.3 |
TR |
24 |
TREVALID |
Evaluator Identifier |
Char |
(MEDEVAL) |
Variable Qualifier |
Used to distinguish multiple evaluators with the same role recorded in TREVAL. Examples:" RADIOLOGIST1", "RADIOLOGIST2". See TR Assumption 6. |
Perm |
|
SDTMIG 3.3 |
TR |
25 |
TRACPTFL |
Accepted Record Flag |
Char |
(NY) |
Record Qualifier |
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. |
Perm |
|
SDTMIG 3.3 |
TR |
26 |
VISITNUM |
Visit Number |
Num |
|
Timing |
Clinical encounter number. Numeric version of VISIT, used for sorting. |
Exp |
|
SDTMIG 3.3 |
TR |
27 |
VISIT |
Visit Name |
Char |
|
Timing |
Protocol-defined description of a clinical encounter. |
Perm |
|
SDTMIG 3.3 |
TR |
28 |
VISITDY |
Planned Study Day of Visit |
Num |
|
Timing |
Planned study day of the visit based upon RFSTDTC in Demographics. |
Perm |
|
SDTMIG 3.3 |
TR |
29 |
TAETORD |
Planned Order of Element within Arm |
Num |
|
Timing |
Epoch associated with the date/time at which the assessment was made. |
Perm |
|
SDTMIG 3.3 |
TR |
30 |
EPOCH |
Epoch |
Char |
(EPOCH) |
Timing |
Epoch associated with the Element in the planned sequence of Elements for the Arm to which the subject was assigned. |
Perm |
|
SDTMIG 3.3 |
TR |
31 |
TRDTC |
Date/Time of Tumor/Lesion Measurement |
Char |
ISO 8601 |
Timing |
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. |
Exp |
|
SDTMIG 3.3 |
TR |
32 |
TRDY |
Study Day of Tumor/Lesion Measurement |
Num |
|
Timing |
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. |
Perm |