| Variable Name | Variable Label | Type | Controlled Terms, Codelist or Format1 | 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 | Unique subject identifier within the submission. | Req |
| PPSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| PPGRPID | Group ID | Char |
| Identifier | Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. | Perm |
| PPTESTCD | Parameter Short Name | Char | (PKPARMCD) | Topic | Short name of the pharmacokinetic parameter. 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: "AUCALL", "TMAX", "CMAX". | Req |
| PPTEST | Parameter Name | Char | (PKPARM) | Synonym Qualifier | Name of the pharmacokinetic parameter. The value in PPTEST cannot be longer than 40 characters. Examples: "AUC All", "Time of CMAX", "Max Conc". | Req |
| PPCAT | Parameter Category | Char | * | Grouping Qualifier | Used to define a category of related records. For PP, this should be the name of 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 PK parameters. Examples: "COMPARTMENTAL", "NON-COMPARTMENTAL". | Perm |
| PPORRES | Result or Finding in Original Units | Char |
| Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp |
| PPORRESU | Original Units | Char | (PKUNIT)
(PKUWG)
(PKUWKG)
(PKUDMG)
(PKUDUG) | Variable Qualifier | Original units in which the data were collected. The unit for PPORRES. Example: "ng/L". See PP Assumption 3. | Exp |
| PPSTRESC | Character Result/Finding in Std 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. | Exp |
| PPSTRESN | Numeric Result/Finding in Standard Units | Num |
| Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from PPSTRESC. PPSTRESN should store all numeric test results or findings. | Exp |
| PPSTRESU | Standard Units | Char | (PKUNIT)
(PKUWG)
(PKUWKG)
(PKUDMG)
(PKUDUG) | Variable Qualifier | Standardized unit used for PPSTRESC and PPSTRESN. See PP Assumption 3 . | 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 Parameter Not Calculated | Char |
| Record Qualifier | Describes why a parameter was not calculated, such as "INSUFFICIENT DATA". Used in conjunction with PPSTAT when value is "NOT DONE". | Perm |
| PPSPEC | Specimen Material Type | Char | (SPECTYPE) | Record Qualifier | Defines the type of specimen used for a measurement. If multiple specimen types are used for a calculation (e.g., serum and urine for renal clearance), then this field should be left blank. Examples: "SERUM", "PLASMA", "URINE". | Exp |
| TAETORD | Planned Order of Element within Arm | Num |
| Timing | Number that gives the planned order of the Element within the Arm. | Perm |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. | Perm |
| PPDTC | Date/Time of Parameter Calculations | Char | ISO 8601 | Timing | Nominal date/time of parameter calculations. | Perm |
| PPDY | Study Day of Parameter Calculations | Num |
| Timing | Study day of the collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| PPRFTDTC | Date/Time of Reference Point | Char | ISO 8601 | Timing | Date/time of the reference time point from the PC records used to calculate a parameter record. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records. | Exp |
| PPSTINT | Planned Start of Assessment Interval | Char | ISO 8601 | Timing | The start of a planned evaluation or assessment interval relative to the Time Point Reference. | Perm |
| PPENINT | Planned End of Assessment Interval | Char | ISO 8601 | Timing | The end of a planned evaluation or assessment interval relative to the Time Point Reference. | Perm |