SEND TF specification

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 dosing 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.

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 datetime or interval

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 applicant-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