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The category of ethnicity is similar to race. Ethnicity, per the CDISC Glossary, "Denotes social groups with a shared history, sense of identity, geography, and cultural roots."  In a fairly heterogeneous country such as the United States, ethnicity data (e.g., "Hispanic or Latino" and "Not Hispanic or Latino")  might be useful to confirm that ethnic groups are not being discriminated against by being unfairly excluded from clinical research. In other countries, regulatory bodies (e.g., Japanese Ministry of Health, Labour and Welfare) may expect the reporting of ethnicity values which appropriately reflect the population of their areas. This information may be collected using the CETHNIC variable with its corresponding codelist, ETHNICC.

If more detailed information on race or ethnicity is required to further characterize study subjects, it is recommended that the presented choices be “collapsible” up to 1 of the 5 FDA designations for race, as well as the 2 categories for representing ethnicity, as needed for reporting to FDA. If more detailed categorizations are desired, the recommendation is to use the HL7 Reference Information Model's race and ethnicity vocabulary tables (available at https://www.hl7.org/ ), which are designed to collapse up in this manner. For the collection of such added detail or granularity, as the sponsor may require, CDASH provides the variables CRACE and CETHNIC, respectively.

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This section describes 2 different data collection scenarios for the demographics domain. It is up to the sponsor to determine which data collection scenario best meets the study needs:

• Scenario 1: Birth  Birth date collection using 3 date fields:  This scenario includes date of birth collected as 3  fields (i.e., month, day, year).
• Scenario 2: Birth date collection using a single date field: This  This scenario includes date of birth collected as a full date, in a single date field.  An example CRF is not shown for this scenario.

Specification

Assumptions