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:
For a same POOLDEF.POOLID, there should be more than one value for POOLDEF.USUBJID
Positive
|| POOLID || USUBJID ||
|| 0001 || B0001 ||
|| 0001 || B0003 ||
|| 0001 || B0005 ||
|| 0001 || B0006 ||
|| 0002 || B0001 ||
|| 0002 || B0002 ||
|| 0002 || B0003 ||
|| 0002 || B0005 ||
Negative
|| POOLID || USUBJID ||
|| 0001 || B0001 ||
|| 0002 || B0001 ||
|| 0002 || B0002 ||
|| 0002 || B0003 ||
|| 0002 || B0005 ||
Currently we do not have a way to count the number of distinct values in a specific subset of data.
Describe the solution
We would need to be able to retrieve a list of USUBJIDs per POOLID and count how many are present in each list
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: For a same POOLDEF.POOLID, there should be more than one value for POOLDEF.USUBJID Positive
|| POOLID || USUBJID ||
|| 0001 || B0001 || || 0001 || B0003 || || 0001 || B0005 || || 0001 || B0006 || || 0002 || B0001 ||
|| 0002 || B0002 ||
|| 0002 || B0003 || || 0002 || B0005 || Negative || POOLID || USUBJID ||
|| 0001 || B0001 || || 0002 || B0001 || || 0002 || B0002 || || 0002 || B0003 || || 0002 || B0005 || Currently we do not have a way to count the number of distinct values in a specific subset of data.
Describe the solution We would need to be able to retrieve a list of USUBJIDs per POOLID and count how many are present in each list
Proposed rule logic