Create RELREC and POOLDEF Domains
When the PK Submit > Create RELREC and POOLDEF Domains menu item is selected, the RELREC and POOLDEF (Sparse analysis only) domains are immediately created and added to the Data folder.
POOLDEF is used to link multiple subjects to a single POOLID. The POOLID itself is created by concatenating the unique combination of all NCA sort variables (excluding the subject).
PK SUBMIT will create the RELREC domain using the many-to-many mapping method. This method links the PC.PCGRPID numbers with the PP.PPGRPID numbers by the RELID value. In the following image, the RELID=1 is used to link ALL records in the PC domain where PCGRPID= “Test Study1-1001A-ABC-111-1” to ALL records in the PP domain where PPGRPID=”Test Study1-1001A-ABC-111-1”.
Note:PK Submit will split all .xpt domains greater than 5 gigabytes (GB) in size into smaller datasets no larger than 5 GB.
Validation of POOLDEF domain creation
Once PK Submit > Create RELREC and POOLDEF Domains is selected from the main menu, PK Submit will perform the following checks:
Check that the POOLID values match between Pool Definition dataset (POOLDEF) and PP domain.
Check that the SEND and dataset variable type match.
Check that the following variables are populated: STUDYID, POOLID, USUBJID.
A failure results in a displayed warning message and/or a message written to the Validation Report in the Documents folder.
Validation of RELREC domain creation
Once PK Submit > Create RELREC and POOLDEF Domains is selected from the main menu, PK Submit will perform the following checks:
Check that the SEND/SDTM and dataset variable type match
Check that the following variables are populated: STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID, RELTYPE (SDTM only).
A failure results in a displayed warning message and/or a message written to the Validation Report in the Documents folder.
