SDTM 3.2

Variable

Description

Class* 

DOMAIN

Set to “PC” for the PC domain, or “PP” for the PP domain.

R

PCCAT

Set to “ANALYTE”.

P

PCDRVFL

Empty column.

P

PCDTC

Reports the SamplingDateTime value in the MasterConcentration worksheet.

E

PCDY

Empty column.

P

PCELTM

Reports the AnalysisNominalTime value in the MasterConcentration worksheet, if this is a Point sample. If this is an Interval sample, PCELTM reports the IntervalEndTime.

P

PCENDTC

Empty column.

P

PCEVLINT

Reports IntervalEndTime - IntervalStartTime.

P

PCFAST

Set to “Y” if FastedFed = Fasted in the MasterConcentration worksheet. Otherwise, PCFAST is empty.

P

PCGRPID

Concatenation of the NCA sort keys, separated by dashes (e.g., Analyte-TreatmentA-Female-Day).

P

PCLLOQ

The LLOQ value in the MasterConcentration worksheet.

E

PCMETHOD

The AssayType value in the MasterConcentration worksheet.

P

PCNAM

Empty column.

E

PCORRES

The Concentration value in the MasterConcentration worksheet.

E

PCORRESU

The ConcentrationUnits mapped to controlled terminology.

E

PCREASND

Empty unless a user-provided description concerning why PCSTAT is NOT DONE or PCORRES is not valued exists, such as SPECIMEN LOST.

P

PCREFID

Empty column.

P

PCRFTDTC

The DoseDateTime value (from the MasterConcentration worksheet).

P

PCSCAT

Empty column.

P

PCSEQ

Unique sequential number identifying records within a dataset.

R

PCSPCCND

Empty column.

P

PCSPEC

The Matrix mapped to controlled terminology.

E

PCSPID

Empty column.

P

PCSTAT

Set to “NOT DONE” if PCORRES is empty, otherwise PCSTAT is empty.

P

PCSTRESC

Copy of PCORRES.

E

PCSTRESN

Reports the numeric equivalent when PCSTRESC contains a numeric result.

E

PCSTRESU

Reports PCORRESU when PCSTRESC contains a numeric result.

E

PCTEST

The Analyte value in the MasterConcentration worksheet (limit of 40 characters).

R

PCTESTCD

Set to “ANALYTEn”, where n is the value assigned to each unique analyte in the study (ANALYTE1-9).

R

PCTPT

Set to “PREDOSE” if AnalysisNominalTime = 0 in the MasterConcentration worksheet. Otherwise, PCTPT = AnalysisNominalTime + TimeUnit + “POSTDOSE”.

P

PCTPTNUM

Reports the AnalysisNominalTime value in the MasterConcentration worksheet if this is a Point sample. If this is an Interval sample, PCTPTNUM reports the IntervalEndTime.

P

PCTPTREF

Set to “Day” + VISITDY “Dose” (from the MasterConcentration worksheet).

P

PCULOQ

The ULOQ value in the MasterConcentration worksheet.

P

PPCAT

Reports the Analyte value in the FinalPKParameters worksheet.

E

PPDTC

Reports the SamplingDateTime value in the FinalPKParameters worksheet.

P

PPENINT

The End Time for the partial area.

P

PPGRPID

Concatenation of the NCA sort keys, separated by dashes (e.g., Analyte-TreatmentA-Female-Day).

P

PPORRES

Empty if EXCLUDE_FLAG = REPORT. Otherwise, PPORRES reports the Estimate value in the FinalPKParameters worksheet.

E

PPORRESU

The Units mapped to controlled terminology.

E

PPREASND

Blank unless a user-provides a description concerning why PPSTAT is NOT DONE or PPORRES is not valued exists, such as SPECIMEN LOST.

P

PPRFTDTC

The DoseDateTime value (from the FinalPKParameter worksheet).

E

PPSCAT

Set to “NON-COMPARTMENTAL”.

P

PPSEQ

Unique sequential number identifying records within a dataset.

R

PPSPEC

The Matrix mapped to controlled terminology.

E

PPSTAT

Set to “NOT DONE” if PPORRES is empty. Otherwise, PPSTAT is empty.

P

PPSTINT

The Start Time for the partial area.

P

PPSTRESC

Copy of PPORRES.

E

PPSTRESN

Reports the numeric equivalent when PPSTRESC contains a numeric result.

E

PPSTRESU

Reports PPORRESU when PPSTRESC contains a numeric result.

E

PPTEST

Copy of PPTESTCD.

R

PPTESTCD

The Parameter mapped to controlled terminology.

R

STUDYID

The StudyID value in the MasterConcentration worksheet.

R

USUBJID

Used if the Subject does not contain the StudyID and is the concatenation of STUDYID-SUBJID.

R

VISIT

Protocol-defined description of clinical encounter (e.g., DAY 1).

P

VISITDY

VisitDay

P

VISITNUM

Numeric version of VISIT

E

SDTM 3.3

All variables in SDTM 3.2, plus:

Variable

Description

Class* 

EPOCH

Empty column.

P

PCENDY

Empty column.

P

PPDY

Reports the AnalysisDay value in the MasterConcentration worksheet.

P

TAETORD

Empty column.

P

SDTM 3.4

All variables in SDTM 3.3, plus:

Variable

Description

Class* 

PPANMETH

Empty column.

P

PPTPTREF

Copy of PCTPTREF.

P


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