SDTM.PP

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	PP	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	PP	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	PP	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Unique subject identifier within the submission.
4	PP	PPSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	PP	PPGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain to support relationships within the domain and between domains.
6	PP	PPTESTCD	Parameter Short Name	Char	C85839	Topic	Req	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".
7	PP	PPTEST	Parameter Name	Char	C85493	Synonym Qualifier	Req	Name of the pharmacokinetic parameter. The value in PPTEST cannot be longer than 40 characters. Examples: "AUC All", "Time of CMAX", "Max Conc".
8	PP	PPCAT	Parameter Category	Char		Grouping Qualifier	Exp	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.
9	PP	PPSCAT	Parameter Subcategory	Char		Grouping Qualifier	Perm	Categorization of the model type used to calculate the PK parameters. Examples: "COMPARTMENTAL", "NON-COMPARTMENTAL".
10	PP	PPORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the measurement or finding as originally received or collected.
11	PP	PPORRESU	Original Units	Char	C85494 C128686 C128683 C128685 C128684	Variable Qualifier	Exp	Original units in which the data were collected. The unit for PPORRES. Example: "ng/L". See PP Assumption 3.
12	PP	PPSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	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.
13	PP	PPSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Exp	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.
14	PP	PPSTRESU	Standard Units	Char	C85494 C128686 C128683 C128685 C128684	Variable Qualifier	Exp	Standardized unit used for PPSTRESC and PPSTRESN. See PP Assumption 3 .
15	PP	PPSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES.
16	PP	PPREASND	Reason Parameter Not Calculated	Char		Record Qualifier	Perm	Describes why a parameter was not calculated, such as "INSUFFICIENT DATA". Used in conjunction with PPSTAT when value is "NOT DONE".
17	PP	PPSPEC	Specimen Material Type	Char	C78734	Record Qualifier	Exp	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".
18	PP	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the Element within the Arm.
19	PP	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.
20	PP	PPDTC	Date/Time of Parameter Calculations	Char	ISO 8601	Timing	Perm	Nominal date/time of parameter calculations.
21	PP	PPDY	Study Day of Parameter Calculations	Num		Timing	Perm	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.
22	PP	PPRFTDTC	Date/Time of Reference Point	Char	ISO 8601	Timing	Exp	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.
23	PP	PPSTINT	Planned Start of Assessment Interval	Char	ISO 8601	Timing	Perm	The start of a planned evaluation or assessment interval relative to the Time Point Reference.
24	PP	PPENINT	Planned End of Assessment Interval	Char	ISO 8601	Timing	Perm	The end of a planned evaluation or assessment interval relative to the Time Point Reference.