Validation of PP domain creation

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

POOLID values match entries in the Pool Definition dataset (POOLDEF).

PPTESTCD is no longer than 8 characters and does not start with a number.

PPTEST is no longer than 40 characters.

The combination of PPTESTCD and PPTEST for each unique parameter name is unique.

PPORRESU and PPSTRESCU are defined in the PKUNIT code list.

When PPORRES is blank, PPSTAT is set to “NOT DONE”.

When PPSTAT=NOT DONE, PPREASND is populated.

When PCSTAT=NOT DONE, the following variables are null: PPORRES, PPSTRESC, PPORRESU, PPSTRESCU, PPSTRESN.

PPRFTDTC is in a valid format.

PPSPEC contains a value in the controlled terminology code list “Specimen Type”.

PPSTINT and PPENINT are in ISO format.

The SEND/SDTM and dataset variable type match.

The following variables are populated: SEND: STUDYID, DOMAIN, USUBJID, PPSEQ, PPTESTCD, PPTEST, PPCAT, PPORRES, PPORRESU, PPSTRESC, PPSTRESN, PPSTRESU, PPSPEC, PPNOMDY (SEND only), PPRFTDTC.

Variables conform with their controlled terms in the code list for SEND or SDTM.

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