DOMAIN

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

R

PCBLFL

Set to “Y” if Period = 0 (zero) or is empty, AnalysisDay = 1, AnalysisNominalTime = 0 (zero), and EXCLUDE_REASON is empty (in the MasterConcentration worksheet). Otherwise, PCBLFL is empty.

E

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

PCENDY

Empty column.

P

PCEVLINT

Empty column.

P

PCEXCLFL

Set to “Y” if, in the MasterConcentration worksheet, EXCLUDE_REASON has a value and “Include Flag in the PC Domain” = Y. Otherwise, PCEXCLFL is empty.

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

Empty column.

P

PCNAM

Empty column.

P

PCORRES

The Concentration value in the MasterConcentration worksheet.

E

PCORRESU

The ConcentrationUnits mapped to controlled terminology.

E

PCREASEX

Set to “EXCLUDE_REASON” if, in the MasterConcentration worksheet, EXCLUDE_REASON has a value and “Include Flag in the PC Domain” = Y. Otherwise, PCREASEX is empty.

P

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).

E

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.

R

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

POOLID

Used instead of USUBJID for Sparse study data and is a concatenation of all NCA sort keys, separated by dashes.

P

PPCAT

Reports the Analyte value in the FinalPKParameters worksheet.

E

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

Empty column.

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

PPTPTREF

Copy of PCTPTREF.

P

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.

E

VISITDY

Reports the Day value in the MasterConcentration worksheet (PC Domain) or in the FinalPKParameters worksheet (PP Domain).

E

PCNOMDY

Reports the AnalysisDay value in the MasterConcentration worksheet.

E

PCNOMLBL

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

P

PCSPCUFL

Empty column.

P

PPNOMDY

Copy of PCNOMDY.

E

PPNOMLBL

Copy of PCNOMLBL.

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.

E (was P in 3.1)

PCTPTREF

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

E (was P in 3.1)

PCUSCHFL

Empty.

P