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Privacy concerns surrounding the DM and Subject Characteristics (SC) data were taken into account when these domains were created. For example, there are optional collection variables to collect the components of birthdate (e.g., BRTHDD, BRTHMO, BRTHYY); therefore, limited elements of birth day birthday may be collected and later mapped to the tabulation variable BRTHDTC. This approach provides flexibility in categorizing some variables to facilitate compliance with local privacy issues.

Collection of Age vs. Date of Birth

It is recognized that applicants may typically collect the age or date of birth of the subject . In but may collect both if required by the study. In multiregional studies, applicants may need to enable the collection of either in order to comply with local regulations. But only one or the other should be collected for any given subject. When only age is collected, the applicant is left with a window of uncertainty of, at most, 365 days. Although knowing the precise date of birth provides the ability to calculate accurately an age for any date, a precise (and complete) date of birth may be considered personally identifying information for some privacy oversight boards or government regulators.

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Date of birth should be implemented such that incomplete dates may be entered, as allowed by the EDC system.

Collection of Sex

The collection of some demographics data Sex is the assemblage of properties or qualities by which male is distinguished from female. This is often collected as it is useful to perform simple analyses based upon population stratification.

Collection of Ethnicity and Race

Ethnicity Race and race 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 non-standard 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). 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 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 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 subject.

applicant.

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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