Stream: Vulcan/RWD
Topic: CM SDTM In Prototype
Priya Gopal (Jan 13 2021 at 23:28):
In clinical research, usually WHODRUG dictionary coding is used . For RWD, I believe it is ICD. Are there any guidelines from FDA on how to provide coded values in SDTM ? can we leave the coding variables blank in case of a regulatory submission?
Geoff Low (Jan 14 2021 at 09:54):
I think ICD would map more directly to MEDDRA, rather than WHODrug. RxNorm would be a better match to WHODRUG (as an example). There are some mappings from ICD10 to MEDDRA (as an example which you can see on bioportal). What you would probably need to do is take the displayText for the coded value and recode that using the 'accepted' dictionary (there's still probaby going to be slots for terms LLT, PT, BODSYS in SDTM for the foreseeable).
Rebecca Baker (Jan 10 2022 at 16:19):
(deleted)
Mike Hamidi (Feb 01 2022 at 18:39):
image.png Source: OHDSI OMOP
Mike Hamidi (Feb 01 2022 at 18:42):
In the case of OMOP, there are concept mappings already available (i.e., concept_relationships). For the case of SDTM, it will require a similar concept mapping exercise. I'll leave the concept mapping itself to the terminology experts.
Last updated: Apr 12 2022 at 19:14 UTC
