Rule Description: Pool ID should match pool definition for nonclinical data.
Describe the problem
The FDAB054 rule can be broken down in multiple sub-rules, one of them being:
A same list of POOLDEF.USUBJID values should be unique to one POOLDEF.POOLID value
or in other words a POOLID is a list of USUBJIDs and there cannot be two lists identical in the POOLDEF dataset
Positive
|| POOLID || USUBJID ||
|| 0001 || B0001 ||
|| 0001 || B0003 ||
|| 0001 || B0005 ||
|| 0001 || B0006 ||
|| 0002 || B0001 ||
|| 0002 || B0002 ||
|| 0002 || B0003 ||
|| 0002 || B0005 ||
Negative
|| POOLID || USUBJID ||
|| 0001 || B0001 ||
|| 0001 || B0003 ||
|| 0001 || B0005 ||
|| 0001 || B0006 ||
|| 0002 || B0001 ||
|| 0002 || B0003 ||
|| 0002 || B0005 ||
|| 0002 || B0006 ||
Currently we do not have a way to compare two list of values in a specific subset of data.
Describe the solution
We would need to be able to retrieve the lists of USUBJIDs per POOLID and compare them to each other to make sure each list is unique
Links to related JIRA Tickets Not existing at the moment
Rule Information
Describe the problem The FDAB054 rule can be broken down in multiple sub-rules, one of them being: A same list of POOLDEF.USUBJID values should be unique to one POOLDEF.POOLID value or in other words a POOLID is a list of USUBJIDs and there cannot be two lists identical in the POOLDEF dataset Positive
|| POOLID || USUBJID ||
|| 0001 || B0001 || || 0001 || B0003 || || 0001 || B0005 || || 0001 || B0006 || || 0002 || B0001 ||
|| 0002 || B0002 ||
|| 0002 || B0003 || || 0002 || B0005 || Negative || POOLID || USUBJID ||
|| 0001 || B0001 || || 0001 || B0003 || || 0001 || B0005 || || 0001 || B0006 || || 0002 || B0001 || || 0002 || B0003 || || 0002 || B0005 || || 0002 || B0006 || Currently we do not have a way to compare two list of values in a specific subset of data.
Describe the solution We would need to be able to retrieve the lists of USUBJIDs per POOLID and compare them to each other to make sure each list is unique
Proposed rule logic