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 | 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 |