We are currently conducting a clinical study that collects RACE on the CRF using the following terms: CAUCASIAN, BLACK, HISPANIC/LATINO, INDIAN, ASIAN/PACIFIC ISLANDER, and OTHER.
We understand that these race codes to not comply with the non-extensible CDISC SDTM Controlled Terminology for RACE, but we are stuck mapping these terms at this point. We have reviewed the FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials as well as the SDTM IG (v3.2).
For now, we have decided to deviate from the non-extensible RACE codelist (using a Sponsor defined codelist) which results in a WARNING after running the data through the OpenCDISC Validator.
Does anyone have any guidance or suggestions based on experience regarding SDTM mappings with noncompliant CRFs terms?
I think the best thing to do is to discuss this with the (reviewer at) the FDA. You are surely not the first one having this problem (we do not have many pacific islander here in Europe...)
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Hi all,
We are currently conducting a clinical study that collects RACE on the CRF using the following terms: CAUCASIAN, BLACK, HISPANIC/LATINO, INDIAN, ASIAN/PACIFIC ISLANDER, and OTHER.
We understand that these race codes to not comply with the non-extensible CDISC SDTM Controlled Terminology for RACE, but we are stuck mapping these terms at this point. We have reviewed the FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials as well as the SDTM IG (v3.2).
For now, we have decided to deviate from the non-extensible RACE codelist (using a Sponsor defined codelist) which results in a WARNING after running the data through the OpenCDISC Validator.
Does anyone have any guidance or suggestions based on experience regarding SDTM mappings with noncompliant CRFs terms?
Thank you,
Aaron