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Collection of Ethnicity and Race

Race and ethnicity will be collected per regulatory requirements.

Collect race if required for the protocol and not prohibited by local laws and regulations. The CDASH Model provides only 1 variable for Race. Applicants wishing to capture more than 1 race will need to create nonstandard variables to store the collection of the multiple races and map appropriately to the tabulation DM domain. Race Other has been included as a free-text field to capture responses. The use of this variable is optional. RACE is Recommended/Conditional (R/C) because some applicants prefer to derive values that are compliant with the codelist RACE (e.g., as derived from values collected in CRACE). For the collection of such added detail or granularity, as the applicant may require, CDASH Model provides the variables CRACE and CETHNIC, respectively.

Collection of Special Optional Fields in Demographics

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