| 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/lesions which have been identified. |
Perm |
| TUREFID |
Reference ID |
Char |
Identifier |
Internal or external identifier, such as a 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 tumor/lesion to the
assessment results (in TR domain) over the course of the study. |
Exp |
| TULNKGRP |
Link Group ID |
Char |
Identifier |
Identifier used to link related records across domains. This
will usually be a many-to-one relationship. |
Perm |
| TUTESTCD |
Tumor/Lesion ID 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 cannot
contain characters other than letters, numbers, or underscores.
Example: "TUMIDENT". See TU Assumption 3. |
Req |
| TUTEST |
Tumor/Lesion ID Test Name |
Char |
Synonym Qualifier |
Verbatim name of the test for the tumor/lesion
identification. The value in TUTEST cannot be longer than 40
characters. Example: "Tumor Identification". See TU Assumption 3. |
Req |
| TUORRES |
Tumor/Lesion ID Result |
Char |
Result Qualifier |
Result of the tumor/lesion identification. The result of
tumor/lesion identification is a classification of the identified
tumor/lesion. Examples: When TUTESTCD = "TUMIDENT", values of
TUORRES might be "TARGET", "NON-TARGET", "NEW", or "BENIGN
ABNORMALITY". |
Exp |
| TUSTRESC |
Tumor/Lesion ID Result Std. Format |
Char |
Result Qualifier |
Contains the result value for all findings copied or derived
from TUORRES in a standard format. |
Exp |
| TUNAM |
Laboratory/Vendor Name |
Char |
Record Qualifier |
The name or identifier of the vendor that performed the
tumor/lesion 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/Lesion |
Char |
Record Qualifier |
Used to specify the anatomical location of the identified
tumor/lesion, e.g., "LIVER" Note: When anatomical location is broken
down and collected as distinct pieces of data that when combined
provide the overall location information (e.g.,
laterality/directionality/distribution), then the additional
anatomical location qualifiers should be used. See Assumption 3. |
Exp |
| TULAT |
Laterality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing laterality, for example, "LEFT", "RIGHT", "BILATERAL". |
Perm |
| TUDIR |
Directionality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing directionality, for example, "UPPER", "INTERIOR". |
Perm |
| TUPORTOT |
Portion or Totality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing the distribution, which means arrangement of, or
apportioning of. Examples: "ENTIRE", "SINGLE", "SEGMENT",
"MULTIPLE". |
Perm |
| TUMETHOD |
Method of Identification |
Char |
Record Qualifier |
Method used to identify the tumor/lesion. Examples: "MRI",
"CT SCAN". |
Exp |
| TULOBXFL |
Last Observation Before Exposure Flag |
Char |
Record Qualifier |
Operationally-derived indicator used to identify the last
non-missing value prior to RFXSTDTC. Should be "Y" or null. |
Exp |
| TUBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. Should be "Y"
or null. Note that TUBLFL is retained for backward compatibility.
The authoritative baseline flag for statistical analysis is in an
ADaM dataset. |
Perm |
| TUEVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. Examples:
"ADJUDICATION COMMITTEE", "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. For
example, the rows attributed to the investigator should contain a
value of "INVESTIGATOR". |
Exp |
| TUEVALID |
Evaluator Identifier |
Char |
Variable Qualifier |
Used to distinguish multiple evaluators with the same role
recorded in --EVAL. Examples: "RADIOLOGIST1", "RADIOLOGIST2". See TU
Assumption 8. |
Perm |
| TUACPTFL |
Accepted Record Flag |
Char |
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 |
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
Protocol-defined description of a clinical encounter. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. Should be an integer. |
Perm |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm for the Element in which the assessment was made. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time at which the assessment
was made. |
Perm |
| TUDTC |
Date/Time of Tumor/Lesion Identification |
Char |
Timing |
TUDTC variable represents the date of the
scan/image/physical exam. TUDTC does not represent the date that the
image was read to identify tumors. TUDTC also does not represent the
VISIT date. |
Exp |
| TUDY |
Study Day of Tumor/Lesion Identification |
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 |