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 | PP | 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. Either USUBJID or POOLID must be populated. | Exp |
POOLID | Pool Identifier | Char |
| Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm |
PPSEQ | Sequence Number | Num |
| Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req |
PPGRPID | Group Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment dosing group number. | Perm |
PPTESTCD | Parameter Short Name | Char | (PKPARMCD) | Topic | Short name of the measurement, test, or examination described in PPTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PPTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: AUCINT, TMAX, CMAX. | Req |
PPTEST | Parameter Name | Char | (PKPARM) | Synonym Qualifier | Long name for PPTESTCD. The value in PPTEST cannot be longer than 40 characters. Examples: AUC from T1 to T2, Time of CMAX, Max Conc. | Req |
PPCAT | Parameter Category | Char |
| Grouping Qualifier | Used to define a category of parameters associated with a specific analyte. This must be the analyte in PCTEST whose profile the parameter is associated with. | Exp |
PPSCAT | Parameter Subcategory | Char |
| Grouping Qualifier | Categorization of the model type used to calculate the pharmacokinetic parameters. Examples include COMPARTMENTAL, NON-COMPARTMENTAL. | Perm |
PPORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the measurement or finding as calculated. | Exp |
PPORRESU | Unit of the Original Result | Char | (PKUNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the CDISC Controlled Terminology list. | Exp |
PPSTRESC | Standardized Result in Character Format | Char |
| Result Qualifier | Contains the result value for all findings, copied or derived from PPORRES in a standard format or standard units. PPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PPSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in PPORRES and these results effectively have the same meaning, they could be represented in standard format in PPSTRESC as NEGATIVE. For other examples, see general assumptions. | Exp |
PPSTRESN | Standardized Result in Numeric Format | Num |
| Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of PPSTRESC. PPSTRESN should store all numeric test results or findings. | Exp |
PPSTRESU | Unit of the Standardized Result | Char | (PKUNIT) | Variable Qualifier | Standardized unit used for PPSTRESC and PPSTRESN. | Exp |
PPSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES. | Perm |
PPREASND | Reason Not Done | Char |
| Record Qualifier | Describes why a parameter was not performed, such as INSUFFICIENT DATA. Used in conjunction with PPSTAT when value is NOT DONE. | Perm |
PPSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine clearance), refer to TIG guidance on how to populate. | Exp |
VISITDY | Planned Study Day of Collection | Num |
| Timing | Planned study day of collection. Should be an integer. | Perm |
PPNOMDY | Nominal Study Day for Tabulations | Num |
| Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp |
PPNOMLBL | Label for Nominal Study Day | Char |
| Timing | A label for a given value of PPNOMDY as presented in the study report. Examples: "Week 4", "Day 28". | Perm |
PPTPTREF | Time Point Reference | Char |
| Timing | Name of the fixed reference point used as a basis for PPRFTDTC. | Exp |
PPRFTDTC | Date/Time of Reference Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, PPTPTREF. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records. | Exp |
PPSTINT | Start of Assessment Interval | Char | ISO 8601 duration | Timing | Start of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT12H. | Perm |
PPENINT | End of Assessment Interval | Char | ISO 8601 duration | Timing | End of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT24H. | Perm |