Page History

STUDYID

Study Identifier

Char

Identifier

Unique identifier for a study.

Req

DOMAIN

Domain Abbreviation

Char

PM

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

PMSEQ

Sequence Number

Num

Identifier

Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.

Req

PMGRPID

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

PMSPID

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

PMTESTCD

Test Short Name

Char

(PHSPRPCD)

Topic

Short name of the measurement, test, or examination described in PMTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PMTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PMTESTCD cannot contain characters other than letters, numbers, or underscores.

Req

PMTEST

Test Name

Char

(PHSPRP)

Synonym Qualifier

Long name for PMTESTCD. The value in PMTEST cannot be longer than 40 characters.

Req

PMORRES

Result or Findings as Collected

Char

Variable Qualifier

Text description of findings as originally received or collected. If the examination was not performed, then the value should be null, and NOT DONE should appear in PMSTAT.

Exp

PMORRESU

Unit of the Original Result

Char

(UNIT)

Variable Qualifier

Units for PMORRES, if available (e.g., for length, width, or depth findings). The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list.

Exp

PMSTRESC

Standardized Result in Character Format

Char

Result Qualifier

Contains the result value for all findings, copied, or derived from PMORRES in a standard format or standard units. PMSTRESC should store all results or findings (without location of finding) in character format; if results are numeric, they should also be submitted in numeric format in PMSTRESN.

Exp

PMSTRESN

Standardized Result in Numeric Format

Num

Result Qualifier

Used for numeric results or findings in standard format; contains the numeric form of PMSTRESC. PMSTRESN should store all numeric test results or findings.

Exp

PMSTRESU

Unit of the Standardized Result

Char

(UNIT)

Variable Qualifier

Standardized unit used for PMSTRESC and PMSTRESN.

Exp

PMSTAT

Completion Status

Char

(ND)

Record Qualifier

Used to indicate when a test is not done or result is missing. Should be null if a result exists in PMORRES.

Perm

PMREASND

Reason Not Done

Char

Record Qualifier

Describes why PMSTAT is NOT DONE, such as MEASUREMENT IMPOSSIBLE DUE TO EXCESSIVE ULCERATION OF MASS.

Perm

PMLOC

Location of a Finding

Char

Record Qualifier

Specifies the location of the palpable mass finding. Example: LEFT SHOULDER.

Exp

PMEVAL

Evaluator

Char

Record Qualifier

Role of the person who provided the evaluation. Example: TECHNICIAN.

Perm

PMUSCHFL

Unscheduled Flag

Char

(NY)

Record Qualifier

Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null.

Perm

VISITDY

Planned Study Day of Collection

Num

Timing

Planned study day of collection. Should be an integer.

Perm

PMDTC

Date/Time of Observation

Char

ISO 8601 datetime or interval

Timing

Date/Time of the observation in ISO 8601 format.

Exp

PMDY

Study Day of Observation

Num

Timing

Study day of the observation, measured as integer days. The algorithm for calculations must be relative to the

applicant-defined RFSTDTC variable in the Demographics (DM) domain.

Perm

PMNOMDY

Nominal Study Day for Tabulations

Num

Timing

Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer.

Exp

PMNOMLBL

Label for Nominal Study Day

Char

Timing

A label for a given value of PMNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac".

Perm