myCSG © |Area: SDTM| Concept: PC : Pharmacokinetics Concentrations | Lesson: L101 : Pharmacokinetics Concentrations - Drug in plasma |

  • Basic programming of SDTM PC dataset
  • PK sampling is done on Day 1 and Day 11 of dosing
  • One predose sample and 3 postdose samples are collected on both the above mentioned days
  • Concentration will generally be not captured on CRF but for sake of simplicity added it on CRF

 


PCON : Pharamcokinetic concentrations
Question Response
Dosing day
[GRPID]

Day 1
Day 11
Date/time of dosing
[DOSING_TIME]
Planned Timepoint
[PCTPT]

PREDOSE
1H30MIN
6H
24H
Date of collection
[PCDAT_RAW]
Time of collection
[PCTIM]
Specimen
[SPEC]

Plasma
Analyte
[ANALYTE]

Drug A
Unit
[UNIT]

ng/mL
Concentration
[RESULT]




PPARAM : Pharamcokinetic parameters (vendor)
Question Response
Dosing day
[GRPID]

Day 1_DrugA
Day 11_DrugA
Specimen
[SPEC]

Plasma
Parameter
[PARAM]

TMAX (H)
CMAX (ug/L)
AUCALL (h*mg/L)
LAMZHL (H)
VZO (L)
Result
[RESULT]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_PCON
_ STUDYID Study Identifier Char Populate as "statschoice"
_ DOMAIN Domain Abbreviation Char Populate as "PC"
_ USUBJID Unique Subject Identifier Char Populate by concatenating "statschoice-" as a prefix to SUBJECT variable.
_ PCSEQ Sequence Number Num Sort the records by USUBJID, PCTESTCD, PCDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject.

seq
_ PCGRPID Group ID Char Populate with the value from GRPID variable.
_ PCTESTCD Pharmacokinetic Test Short Name Char Populate as "DRUGA"
_ PCTEST Pharmacokinetic Test Name Char Populate as "Drug A"
_ PCORRES Result or Finding in Original Units Char Populate with the value from RESULT variable.
_ PCORRESU Original Units Char Populate with the value from UNIT variable.
_ PCSTRESC Character Result/Finding in Std Format Char Populate with the value from RESULT variable.
_ PCSTRESN Numeric Result/Finding in Standard Units Num Populate with the numeric value of PCSTRESC where applicable.
_ PCSTRESU Standard Units Char Populate with the value from UNIT variable.
_ PCSPEC Specimen Material Type Char Populate with the value from SPEC variable.
_ PCLLOQ Lower Limit of Quantitation Num Populate as "0.10".
_ PCULOQ Upper Limit of Quantitation Num Populate as "20"
_ VISITNUM Visit Number Num Populate with the value from FOLDERSEQ variable.
_ VISIT Visit Name Char Populate with the value from FOLDERNAME variable - use only the first word before hyphen.
_ PCDTC Date/Time of Specimen Collection Char Populate using PCDAT_RAW and PCTIM, after converting to ISO 8601 format.
_ PCTPT Planned Time Point Name Char Populate with the value from PCTPT variable.
_ PCTPTNUM Planned Time Point Number Num Set to 0 when PCTPT="PREDOSE".
Set to 1.5 when PCTPT="1H30MIN".
Set to 6 when PCTPT="6H".
Set to 24 when PCTPT="24H".
_ PCELTM Planned Elapsed Time from Time Point Ref Char Set to "-PT15M when PCTPT="PREDOSE".
Set to "PT1H30M" when PCTPT="1H30MIN".
Set to "PT6H" when PCTPT="6H".
Set to "PT24H when PCTPT="24H".
_ PCTPTREF Time Point Reference Char Concatenate the GRPID variable value with " Dose" as a suffix.
_ PCRFTDTC Date/Time of Reference Point Char Populate with the value from DOSING_TIME variable.
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