Variable | Description | |
---|---|---|
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 |
All variables in SDTM 3.2, plus:
Variable | Description | |
---|---|---|
EPOCH | Empty column. | P |
PCENDY | Empty column. | P |
PPDY | Reports the AnalysisDay value in the MasterConcentration worksheet. | P |
TAETORD | Empty column. | P |
All variables in SDTM 3.3, plus:
Variable | Description | |
---|---|---|
PPANMETH | Empty column. | P |
PPTPTREF | Copy of PCTPTREF. | P |
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