| 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 |
| TUSEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness within a
dataset for a subject. May be any valid number. |
Req |
| TUGRPID |
Group ID |
Char |
Identifier |
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. |
Perm |
| TUREFID |
Reference ID |
Char |
Identifier |
Internal or external identifier. Example: Medical image ID
number. |
Perm |
| TUSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined identifier. |
Perm |
| TULNKID |
Link ID |
Char |
Identifier |
Identifier used to link identified tumors to the
assessment results (in TR domain) over the course of the study. |
Exp |
| TUTESTCD |
Tumor Identification Short Name |
Char |
Topic |
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. |
Req |
| TUTEST |
Tumor Identification Test Name |
Char |
Synonym Qualifier |
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. |
Req |
| TUORRES |
Tumor Identification Result |
Char |
Result Qualifier |
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. |
Exp |
| TUSTRESC |
Tumor Identification Result Std. Format |
Char |
Record Qualifier |
Contains the result value for all findings copied from
TUORRES. |
Exp |
| TUNAM |
Vendor Name |
Char |
Record Qualifier |
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. |
Perm |
| TULOC |
Location of the Tumor |
Char |
Record Qualifier |
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 locationinformation (e.g. laterality
/directionality / distribution) then the additional anatomical
location qualifiers should be used. See Assumption 3. |
Exp |
| TULAT |
Laterality |
Char |
Record Qualifier |
Qualifier for anatomical location or specimen further
detailing laterality, for example, LEFT, RIGHT, BILATERAL. |
Perm |
| TUDIR |
Directionality |
Char |
Record Qualifier |
Qualifier for anatomical location or specimen further
detailing directionality, for example, UPPER, INTERIOR. |
Perm |
| TUPORTOT |
Portion or Totality |
Char |
Record Qualifier |
Qualifier for anatomical location or specimen
further detailing the distribution which means arrangement of, or
apportioning of, for example, ENTIRE, SINGLE, SEGMENT, MULTIPLE.
|
Perm |
| TUMETHOD |
Method of Identification |
Char |
Record Qualifier |
Method used to identify the tumor. Examples: MRI, CT SCAN.
|
Exp |
| TUEVAL |
Evaluator |
Char |
Record Qualifier |
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 containno 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 |
| TUEVALID |
Evaluator Identifier |
Char |
Variable Qualifier |
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 thenames 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. |
Perm |
| TUACPTFL |
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 time point this flag
identifies the record that is considered to be the accepted
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 |
|
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 |
| TUDTC |
Date/Time of Tumor Identification |
Char |
Timing |
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. |
Exp |
| TUDY |
Study Day of Tumor Identification |
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 |