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Collection of Ethnicity and RaceEthnicity

Race and

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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

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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

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)

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. For the collection of such added detail or granularity, as the

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applicant may require, CDASH Model provides the variables CRACE and CETHNIC, respectively.

Collection of Special Optional Fields in Demographics

CDASHIG allows TIG collection standards allow for collection of the Date of Informed Consent using the variable RFICDAT. (If a sponsor an applicant chooses to collect Informed Consent using this variable, the data should not also be collected using DSSTDAT from the Disposition (DS) Domain.) The data from RFICDAT would then be mapped to the SDTMIG tabulation variable DSSTDTC and the companion variables (e.g., DSTERM, DSDECOD) must be populated accordingly.

The CDASH Model also defines a field for death date (DTHDAT) as a timing variable. It may be collected on any CRF deemed appropriate by the sponsorapplicant. The SDTMIG  The tabulation variables DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. The CDASH collection field Death Date may be mapped to other SDTMIG domains tabulation domains (e.g., DS), as deemed appropriate by the sponsor.See Section 4.1, Best Practices for Creating Data Collection Instruments, Num 4 for additional guidance recommending that the same data not be collected more than 1 time per subjectapplicant.

Data Collection Scenarios

This section describes 2 different data collection scenarios for the demographics domain. It is up to the sponsor applicant 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  3 fields (i.e., month, day, year).
• Scenario 2: Birth date collection using a single date field: 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.

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