| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
| 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 |
| TRSEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness within a
dataset for a subject. May be any valid number. |
Req |
| TRGRPID |
Group ID |
Char |
Identifier |
Used to link together a block of related records within a
subject in a domain. |
Perm |
| TRREFID |
Reference ID |
Char |
Identifier |
Internal or external identifier. |
Perm |
| TRSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined identifier. |
Perm |
| TRLNKID |
Link ID |
Char |
Identifier |
Identifier used to link the assessment result records to
the individual tumor identification record in TU domain. |
Exp |
| 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 |
| TRTESTCD |
Tumor Assessment Short Name |
Char |
Topic |
Short name of the TEST in TRTEST. TRTESTCD cannot contain
characters other than letters, numbers, or underscores. Examples:
TUMSTATE, DIAMETER. See Assumption 2. |
Req |
| TRTEST |
Tumor Assessment Test Name |
Char |
Synonym Qualifier |
Short name of the TEST in TRTEST. TRTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: TUMSTATE, DIAMETER. See Assumption 2. |
Req |
| TRORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the Tumor measurement/assessment as originally
received or collected. |
Exp |
| TRORRESU |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. The unit
for TRORRES. Example: mm |
Exp |
| TRSTRESC |
Character Result/Finding in Std Format |
Char |
Record 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 orfindings in character format;
if results are numeric, they should also be stored in numeric
format in TRSTRESN |
Exp |
| 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 |
| TRSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized unit used for TRSTRESN. |
Exp |
| TRSTAT |
Completion Status |
Char |
Result Qualifier |
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. |
Perm |
| TRREASND |
Reason Tumor Measurement Not Performed |
Char |
Record Qualifier |
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. |
Perm |
| TRNAM |
Vendor Name |
Char |
Record Qualifier |
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.
|
Perm |
| TRMETHOD |
Method used to Identify the Tumor |
Char |
Record Qualifier |
Method used to measure the tumor. Examples: MRI, CT SCAN.
|
Exp |
| TREVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. Examples:
INVESTIGATOR, INDEPENDENT ASSESSOR. This column can be left Null
when the Investigator provides the complete setof 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. |
Exp |
| TREVALID |
Evaluator Identifier |
Char |
Variable Qualifier |
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 toa 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. SeeAssumption
7. |
Perm |
| TRACPTFL |
Accepted Record Flag |
Char |
Record Qualifier |
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 theaccepted assessment. |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
1. Clinical encounter number. 2. Numeric version of VISIT,
used for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
1. Protocol-defined description of clinical encounter. 2.
May be used in addition to VISITNUM and/or VISITDY. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the Element in the planned sequence
of Elements for the ARM to which the subject was assigned |
Perm |
| TRDTC |
Date/Time of Tumor Measurement |
Char |
Timing |
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.
|
Exp |
| TRDY |
Study Day of Tumor Measurement |
Num |
Timing |
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. |
Perm |