Validation of PC domain creation

Once Submit is clicked in the wizard, PK Submit performs numerous checks, including the following:

•STUDYID is unique for the PC domain.

•The following variables are “Y” or “null”: PCFAST, PCSPCUFL, PCBLFL, and PCEXCLFL.

•PCTEST is less than 40 characters.

•The combinations of PCTEST and PCTESTCD are unique. Every PCTEST value should only have one PCTESTCD.

•The contents of PCORRESU and PCSTRESU are defined in the PKUNIT code list.

•When PCBLFL=Y, PCSTRESC and PCSTRESU are populated.

•PCTPTNUM and PCTPT are the same.

•PCTPTNUM and PCELTM are the same.

•PCRFTDTC, PCDTC and PCENDTC are in a valid format.

•When PCENDTC is populated, PCENDY is populated as well.

•When PCRFTDTC is populated, PCTPTREF is populated as well.

•Proper order of columns and the type for each variable.

•The following variables are populated: STUDYID, DOMAIN, USUBJID, PCSEQ, PCTESTCD, PCTEST, PCORRES, PCORRESU, PCSTRESC, PCSTRESN, PCSTRESU, PCNAM (SDTM only), PCSPEC, PCBLFL (SEND only), PCLLOQ, VISITNUM (SDTM only), PCDTC, PCNOMDY (SEND only), PCRFTDTC (SEND only).

•Variables conform with their controlled terms in the code list.

A failure results in a displayed warning message and/or a message written to the Validation Report in the created Phoenix project Documents folder.