ACYCLE

Record-level identifier that reflects cycle; either both ACYCLE and ACYCLEC are present or set to NULL.

P

ACYCLEC

Record-level identifier that reflects cycle; either both ACYCLE and ACYCLEC are present or set to NULL.

P

ADOSEDUR

Difference between PCRFEDTM and PCRFDTM values.

C

ADT

Date derived from the PCDTC value in the PC worksheet.

P

ADTM

The PCDTC value in the PC worksheet. For duplicate samples, set to next day.

P

AEFRLT

ActualTime, associated with end of sampling interval (e.g., urine) from first exposure.

P

AENDT

For Interval Collection associated with AVAL.

P

AENDTM

For Interval Collection associated with AVAL.

P

AENTM

For Interval Collection associated with AVAL.

P

AERRLT

Actual time, associated with end of sampling interval (e.g., urine) from reference exposure.

P

AFRLT

ActualTime, associated with sample point (e.g., plasma) or start of sampling interval (e.g., urine) from first exposure. Based on cumulative time for a subject who has multiple profiles.

P

AGE

If DM is imported, it is the AGE value in the DM worksheet.

R

ALLOQ

The PCLLOQ value in the PC worksheet but could be overwritten if PCLLOQ does not support analysis needs.

C

APERIOD

Derived from VISIT or PCTPTREF values in the PC worksheet. For example:
If VISIT = Period 1, Day 1 then APERIOD = PERIOD 1
Or
If PCTPTREF = Period 1, Day 1 then APERIOD = PERIOD 1

P

APERIODC

Derived from VISIT or PCTPTREF values in the PC worksheet. For example:
If VISIT = Period 1, Day 1 then APERIODC = PERIOD 1
Or
If PCTPTREF = Period 1, Day 1 then APERIODC = PERIOD 1

P

ARRLT

ActualTime, associated with sample point (e.g., plasma) or start of sampling interval (e.g., urine) from reference exposure. Based on time per profile. For duplicate samples, set to next day.

R

ASEQ

Sequence number given to ensure uniqueness of subject records within an ADaM dataset.

P

ASTDT

For Interval Collection associated with AVAL.

P

ASTDTM

For Interval Collection associated with AVAL.

P

ASTTM

For Interval Collection associated with AVAL.

P

ATM

Time derived from PCDTC value in the PC worksheet.

P

ATPT

Reports the PCTPT value in the PC worksheet. For duplicate samples, set to Predose.

C

ATPTN

Reports the PCTPTNUM value in the PC worksheet.

P

ATPTREF

Reports PCTPTREF value in the PC worksheet. For duplicate samples, set to next day.

P

AVAL

Reports the PCSTRESN value in the PC worksheet.

C

AVALU

Units for AVAL.

R

AVISIT

Reports the VISIT value from the PC worksheet.

C

AVISITN

Reports the VISITNUM value from the PC worksheet.

P

COHORT

Relevant to trials where cohorts are defined. This could be another grouping not necessarily associated with ARM.

P

COHORTN

Numeric representation of the COHORT variable. There must be a one-to-one mapping between COHORT and COHORTN. When COHORT and COHORTN are present, then, on a given record, either both must be populated or both must be NULL.

P

DOSEA

Reports the EXDOSE value in the EX worksheet (or Dose entered by the user on the dosing screen).

P

DOSEDURU

Units associated with ADOSEDUR and NDOSEDUR. When ADOSEDUR is present, NDOSEDUR and/or DOSEDURU must also be included in the dataset.

P

DOSEFRQ

For multiple dose studies, the number of repeated administrations of DOSE within a subject’s profile.

C

DOSEP

Reports the EXDOSE value in the EX worksheet (or the Dose entered by the user on the dosing screen).

P

DOSEU

Reports the EXDOSU value in the EX worksheet (or the Unit entered by the user on the dosing screen).

P

DOSPCTDF

(100*(DOSEA-DOSEP)/(DOSEP)). This is a required variable if DOSEA and DOSEP are populated.

C

DTYPE

Set to COPY for any sample duplications. For all other imputed samples, codes from the C81224 codelist are used.

C

FANLDT

For multiple dose studies, the date of the first exposure to treatment associated with PARAM and ANALYTE for a subject.

P

FANLDTM

For multiple dose studies, the date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject.

P

FANLEDT

For multiple dose studies, the end date of first exposure to treatment associated with PARAM and ANALYTE for a subject.

P

FANLEDTM

For multiple dose studies, the end date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject.

P

FANLETM

For multiple dose studies, the end time of first exposure to treatment associated with PARAM and ANALYTE for a subject.

P

FANLTM

For multiple dose studies, the time of first exposure to treatment associated with PARAM and ANALYTE for a subject.

P

FRLTU

Unit for all elapsed times from first dose.

P

MERRLT

Based on AnalysisNominalTime. This variable could be used to modify the AERRLT variable based on analysis needs (e.g., setting negative values to zero or having a mix of nominal and actual time based on TMPCTDF).

P

METABFL

Set to “Y” if observations within a subject are associated with a metabolite. This is a required variable, if parent drug and metabolites are present in the dataset.

C

MRRLT

Based on AnalysisNominalTime. This variable could be used to modify the ARRLT variable based on analysis needs (e.g., setting negative values to zero or having a mix of nominal and actual time based on TMPCTDF). For duplicated samples, set to 0.

P

NCAwXRS

Exclusion reason.

P

NCAwXRSN

Exclusion Type Code.

P

NCAXFL

Y = exclusion; NULL = inclusion.

P

NCAXFN

1 = exclusion; NULL = inclusion. If NCAXFL is generated, must also generate NCAXFN.

P

NDOSEDUR

Infusion duration.

C

NEFRLT

NominalTime, associated with end of sampling interval (e.g., urine) from first exposure.

P

NERRLT

NominalTime, associated with end of sampling interval (e.g., urine) from reference exposure.

P

NFRLT

Planned time associated with sample point (e.g., plasma) or start of sampling interval (e.g., urine) from first exposure. Based on cumulative time for a subject who has multiple profiles.

P

NRRLT

NominalTime, associated with sample point (e.g., plasma) or start of sampling interval (e.g., urine) from reference exposure. Based on time per profile. For duplicated samples, set to 0.

P

PARAM

Reports the PCTEST value in the PC worksheet.

R

PARAMCD

Reports the PCTESTCD value in the PC worksheet.

R

PARAMN

Numeric representation of PARAM. Useful for ordering and programmatic manipulation. There must be a one-to-one mapping to PARAM within a dataset.

P

PCGRPID

Reports the PCGRPID value in the PC worksheet.

P

PCLLOQ

Reports the PCLLOQ value in the PC worksheet. This must be a direct copy of PC.PCLLOQ.

E

PCRFEDT

The end date of reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.

C

PCRFEDTM

The end date and time of the reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.

C

PCRFETM

The end time of the reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.

C

PCRFTDT

Reports the PCRFTDTC value in the PC worksheet.

R

PCRFTDTM

Reports the PCRFTDTC value in the PC worksheet. For duplicate samples, set to the next day.

R

PCRFTTM

Reports the PCRFTDTC value in the PC worksheet.

R

PCSEQ

The PCSEQ value in the PC worksheet associated with AVAL. For duplicate samples, set to the value of the original sample.

R

PCSPEC

Reports the PCSPEC value in the PC worksheet.

R

PCSTRESC

Reports the PCSTRESC value in the PC worksheet.

E

PCSTRESU

Reports the PCSTRESU value in the PC worksheet.

E

PKSUMXF

Y = exclusion; NULL = inclusion.

P

PKSUMXFN

1 = exclusion; NULL = inclusion. If PKSUMXF is generated, must also generate PKSUMXFN.

P

RACE

Reports the RACE value in the DM worksheet.

R

ROUTE

Reports the EXROUTE value in the EX worksheet.

P

RRLTU

Unit for all elapsed times from reference dose.

R

SEX

Reports the SEX value from the DM worksheet.

R

SITEID

If DM is imported, reports the SITEID value from the DM worksheet. If not, do not include.

P

SPWEIGHT

Reports the PCSTRESN value from the PC worksheet for a PC specimen weight record, adjustment based on LLOQ rules possible. This is the specimen weight associated with AVAL. Conditionally required if the sample is interval based collection, such as a potential non-fluid matrix (e.g., feces).

C

SPWEIGHU

Reports the PCSTRESU value from the PC worksheet for a PC weight record. Conditionally required if SPWEIGHT is present.

C

STUDYID

If DM is imported, reports the STUDYID value from the DM worksheet. If not, reports the STUDYID value from the PC worksheet.

R

SUBJID

If DM is imported, reports the SUBJID from the DM worksheet. If not, do not include.

P

TMPCTDF

100*(NRRLT - ARRLT)/(NRRLT).

P

TRTA

Reports the TRT0xA value in the ADSL worksheet, if ADSL is imported and if APERIOD = x. For example, if APERIOD = 1 then TRTA = TRT01A. If ADSL is not imported, this variable is not included.

C

TRTAN

Reports the TRT0xAN value in the ADSL worksheet, if ADSL is imported and if APERIOD = x. For example, if APERIOD = 1 then TRTAN = TRT01AN. If ADSL is not imported, this variable is not included.

P

TRTP

Reports the TRT0xP value in the ADSL worksheet, if ADSL is imported and if APERIOD = x. For example, if APERIOD = 1 then TRTP = TRT01P. If ADSL is not imported, this variable is not included.

C

TRTPN

Reports the TRT0xPN value in the ADSL worksheet, if ADSL is imported and if APERIOD= x. For example, if APERIOD = 1 then TRTPN = TRT01PN. If ADSL is not imported, this variable is not included.

P

TRTRINT

Set to Tau if entered by the user.

P

TRTRINTU

Based on Tau. Most likely set to the TimeUnits.

P

USUBJID

If DM is imported, reports the USUBJID value from the DM worksheet. If not, reports the USUBJID value from the PC worksheet.

R

VOLUME

Reports the PCSTRESN value from the PC worksheet for a PC Volume Record. This is required if VOLUME is present and if sample is based on interval collection (e.g., urine).

C

VOLUMEU

Reports the PCSTRESU value from the PC worksheet for a PC Volume Record. This is required if VOLUME is present and if sample is based on interval collection (e.g., urine).

C