ROWORDER | SUPP | VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT | FORM_PCON |
---|---|---|---|---|---|---|
001 | STUDYID | Study Identifier | Char | Populate as "MYCSG" | ||
002 | DOMAIN | Domain Abbreviation | Char | Populate as "PC" | ||
003 | USUBJID | Unique Subject Identifier | Char | Populate by concatenating "MYCSG-" as a prefix to SUBJECT variable. | ||
004 | 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. | ||
005 | PCGRPID | Group ID | Char | Populate with the value from GRPID variable. | ||
006 | PCTESTCD | Pharmacokinetic Test Short Name | Char | Populate as "DRUGA" | ||
007 | PCTEST | Pharmacokinetic Test Name | Char | Populate as "Drug A" | ||
008 | PCORRES | Result or Finding in Original Units | Char | Populate with the value from RESULT variable. | ||
009 | PCORRESU | Original Units | Char | Populate with the value from UNIT variable. | ||
010 | PCSTRESC | Character Result/Finding in Std Format | Char | Populate with the value from RESULT variable. | ||
011 | PCSTRESN | Numeric Result/Finding in Standard Units | Num | Populate with the numeric value of PCSTRESC where applicable. | ||
012 | PCSTRESU | Standard Units | Char | Populate with the value from UNIT variable. | ||
013 | PCSPEC | Specimen Material Type | Char | Populate with the value from SPEC variable. | ||
014 | PCLLOQ | Lower Limit of Quantitation | Num | Populate as "0.10". | ||
015 | PCULOQ | Upper Limit of Quantitation | Num | Populate as "20" | ||
016 | VISITNUM | Visit Number | Num | Populate with the value from FOLDERSEQ variable. | ||
017 | VISIT | Visit Name | Char | Populate with the value from FOLDERNAME variable - use only the first word before hyphen. | ||
018 | PCDTC | Date/Time of Specimen Collection | Char | Populate using PCDAT_RAW and PCTIM, after converting to ISO 8601 format. | ||
019 | PCTPT | Planned Time Point Name | Char | Populate with the value from PCTPT variable. | ||
020 | 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". |
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021 | 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". |
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022 | PCTPTREF | Time Point Reference | Char | Concatenate the GRPID variable value with " Dose" as a suffix. | ||
023 | PCRFTDTC | Date/Time of Reference Point | Char | Populate with the value from DOSING_TIME variable. |