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CDISC Pharmacogenomic Variables not recognized by P21E
SergiyOfficially, there is no CDISC standard for PGx domains
Hi Shay,
Officially, there is no CDISC standard for Pharmacogenomics domains. CDISC PGx implementation guide was published in 2015 as "Provisional". This means that this document includes many new variables and special domains which are not supported by CDISC SDTM Model.
The intention was to include these new variables and domains in the next release of SDTM Model. After that CDISC PGx IG would be promoted to official CDISC standard. Until then a "Provisional" version is still a draft version with many expected changes. The CDISC team was planning to add new PGx variables into SDTM Model but then pulled them back because it was decided that they were not well-defined.
To be CDISC compliant, if you want to use new PGx variables you should add them as SUPPQUAL variables (note today there is no CDISC-compliant solution for use of RELSPEC dataset). However, we do not think that this is a good implementation in terms of data usability.
Our advice is to contact FDA eData team and ask them and the reviewers assigned to your application.
Note that eData team email may be different depends on FDA Division you are filing to. E.g., edata@fda.hhs.gov or cder-edata@fda.hhs.gov See more details on https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources
Kind Regards,
Sergiy
We have recently mapped Pharmacogenomic data to PF domain, when validating the data we get error SD0058: Variable appears in dataset, but is not in SDTM model, although, the variables PFGENTYP and PFGENRI are part of PF according to CDISC implementation guide for Pharmacogenomics and Pharmacogenetics.