We have a situation in the study we are working on and would like to get pointers as to how to go about it.
We are creating SDTM datasets for a study where the mothers get enrolled in the second/third trimester of their pregnancy and the babies get the investigational product after birth. Here, the babies get the same SUBJID as the mother. In case of multiple births, one baby will get the mother's SUBJID and the other babies will be assigned new SUBJIDs (and these babies will have the same mother screening number)
In this study, demographic data of the mothers is not being collected, and only data points regarding delivery route, single/multiple birth and preliminary consent date are being captured. Now, can these be mapped to APSC?
Also, we would like to know how to present the RSUBJID in the AP domains, where one APID is related to multiple babies. In the web, we can find articles providing example for creating the POOLDEF dataset where two APIDs are related to a single SUBJID. We would like to know if the reverse scenario is acceptable, where a POOLDEF is created to derive one POOLID for one APID with relationship to multiple RSUBJIDs. Can we create the POOLID for the multiple birth babies and populate the POOLID in RSUBJID for records in AP domains?
It would be great to get opinions on the above queries. Thanks!
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We have a situation in the study we are working on and would like to get pointers as to how to go about it.
We are creating SDTM datasets for a study where the mothers get enrolled in the second/third trimester of their pregnancy and the babies get the investigational product after birth. Here, the babies get the same SUBJID as the mother. In case of multiple births, one baby will get the mother's SUBJID and the other babies will be assigned new SUBJIDs (and these babies will have the same mother screening number)
In this study, demographic data of the mothers is not being collected, and only data points regarding delivery route, single/multiple birth and preliminary consent date are being captured. Now, can these be mapped to APSC?
Also, we would like to know how to present the RSUBJID in the AP domains, where one APID is related to multiple babies. In the web, we can find articles providing example for creating the POOLDEF dataset where two APIDs are related to a single SUBJID. We would like to know if the reverse scenario is acceptable, where a POOLDEF is created to derive one POOLID for one APID with relationship to multiple RSUBJIDs. Can we create the POOLID for the multiple birth babies and populate the POOLID in RSUBJID for records in AP domains?
It would be great to get opinions on the above queries. Thanks!