Description

A findings domain that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data.


Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharPPIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierUnique subject identifier within the submission.Req
PPSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
PPGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain to support relationships within the domain and between domains.Perm
PPTESTCDParameter Short NameChar(PKPARMCD)TopicShort 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
PPTESTParameter NameChar(PKPARM)Synonym QualifierName of the pharmacokinetic parameter. The value in PPTEST cannot be longer than 40 characters. Examples: "AUC All", "Time of CMAX", "Max Conc".Req
PPCATParameter CategoryChar
Grouping QualifierUsed 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
PPSCATParameter SubcategoryChar
Grouping QualifierCategorization of the model type used to calculate the PK parameters. Examples: "COMPARTMENTAL", "NON-COMPARTMENTAL".Perm
PPORRESResult or Finding in Original UnitsChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
PPORRESUOriginal UnitsChar(PKUNIT)
(PKUWG)
(PKUWKG)
(PKUDMG)
(PKUDUG)
Variable QualifierOriginal units in which the data were collected. The unit for PPORRES.Exp
PPSTRESCCharacter Result/Finding in Std FormatChar
Result QualifierContains 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
PPSTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed 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
PPSTRESUStandard UnitsChar(PKUNIT)
(PKUWG)
(PKUWKG)
(PKUDMG)
(PKUDUG)
Variable QualifierStandardized unit used for PPSTRESC and PPSTRESN.Exp
PPSTATCompletion StatusChar(ND)Record QualifierUsed to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES.Perm
PPREASNDReason Parameter Not CalculatedChar
Record QualifierDescribes why a parameter was not calculated, such as "INSUFFICIENT DATA". Used in conjunction with PPSTAT when value is "NOT DONE".Perm
PPSPECSpecimen Material TypeChar(SPECTYPE)Record QualifierDefines 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
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the Element within the Arm.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.Perm
PPDTCDate/Time of Parameter CalculationsCharISO 8601 datetime or intervalTimingNominal date/time of parameter calculations.Perm
PPDYStudy Day of Parameter CalculationsNum
TimingStudy day of the collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm
PPRFTDTCDate/Time of Reference PointCharISO 8601 datetime or intervalTimingDate/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
PPSTINTPlanned Start of Assessment IntervalCharISO 8601 durationTimingThe start of a planned evaluation or assessment interval relative to the Time Point Reference.Perm
PPENINTPlanned End of Assessment IntervalCharISO 8601 durationTimingThe end of a planned evaluation or assessment interval relative to the Time Point Reference.Perm


Assumptions

  1. It is recognized that PP is a derived dataset, and may be produced from an analysis dataset with a different structure.
  2. Information pertaining to all parameters (e.g., number of exponents, model weighting) should be submitted in the SUPPPP dataset.
  3. There are separate codelists used for PPORRESU/PPSTRESU where the choice depends on whether the value of the pharmacokinetic parameter is normalized.
    • Codelist “PKUNIT” is used for non-normalized parameters.
    • Codelists “PKUDMG” and “PKUDUG” are used when parameters are normalized by dose amount in milligrams or micrograms respectively.
    • Codelists “PKUWG” and “PKUWKG” are used when parameters are normalized by weight in grams or kilograms respectively.
    Multiple subset codelists were created for the unique unit expressions of the same concept across codelists, this approach allows study-context appropriate use of unit values for PK analysis subtypes.
  4. Any Identifiers, Timing variables, or Findings general observation class qualifiers may be added to the PP domain, but the following qualifiers would not generally be used in PP: --BODSYS, --SEV.

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