Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
DOMAIN | Domain Abbreviation | Char | TF | 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 within the submission | Req |
TFSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
TFGRPID | Group Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm |
TFREFID | Specimen Identifier | Char |
| Identifier | Internal or external specimen identifier. Example: Specimen barcode number. | Perm |
TFSPID | Mass Identifier | Char |
| Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Exp |
TFTESTCD | Tumor Examination Short Name | Char | (TFTESTCD) | Topic | Short name of the measurement, test, or examination described in TFTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in TFTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). TFTESTCD cannot contain characters other than letters, numbers, or underscores. Example: TUMEX. | Req |
TFTEST | Tumor Examination Name | Char | (TFTEST) | Synonym Qualifier | Long name for TFTESTCD. The value in TFTEST cannot be longer than 40 characters. Example: Tumor Examination. | Req |
TFORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the histopathological examination as originally received or collected. | Exp |
TFSTRESC | Standardized Result in Character Format | Char | (NEOPLASM) | Result Qualifier | Contains the tumor name mapped from TFORRES into a standard format from the controlled terms list. | Exp |
TFRESCAT | Tumor Malignancy Status | Char | (NEOSTAT) | Variable Qualifier | Used to record the malignancy of the tumor as determined by the pathologist. It may be copied or derived from a description in TFORRES. Examples: BENIGN, MALIGNANT, METASTATIC, and UNDETERMINED. | Req |
TFNAM | Laboratory Name | Char |
| Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm |
TFSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, organ, or fluid specimen examined. Examples: LIVER, HEART. | Req |
TFANTREG | Anatomical Region of Specimen | Char |
| Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the TFSPEC variable. If the anatomical region is not included in the specimen description TFSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm |
TFSPCCND | Specimen Condition | Char |
| Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Perm |
TFLAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm |
TFDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm |
TFMETHOD | Method of Test or Examination | Char |
| Record Qualifier | Method of the test or examination. This could be different types of staining used for the slides. Example: H&E. | Perm |
TFEVAL | Evaluator | Char |
| Record Qualifier | Role of the person who provided the evaluation. Example: TOX PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST. | Perm |
TFDTHREL | Relationship to Death | Char | (NY) | Record Qualifier | Describes the relationship of a particular finding to the death of a subject. Example: Y if the tumor was the cause of death, N if the tumor was not the cause of death, or U for Unknown. Null cannot be used because the variable is required. | Req |
TFDTC | Date/Time | Char | ISO 8601 | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format. | Perm |
TFDY | Study Day | Num |
| Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
TFDETECT | Time in Days to Detection of Tumor | Num |
| Timing | The number of days from the start of dosing to the earliest detection of the tumor in the experimental phase. This variable must be populated for every tumor discovered during the experimental phase. | Req |