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Description

The CDASHIG Demographics (DM) domain includes essential data collection fields that describe each subject in a clinical study. The collection of some demographics data is useful to perform simple analyses based upon population stratification.

Privacy concerns surrounding the DM and Subject Characteristics (SC) data were taken into account when these domains were created. For example, there are optional CDASHIG variables to collect the components of birthdate (e.g., BRTHDD, BRTHMO, BRTHYY); therefore, limited elements of birth day may be collected and later mapped to the SDTMIG 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 sponsors may collect the age or date of birth of the subject. In multiregional studies, sponsors 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 sponsor 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.

Collect the date of birth to the extent that the local regulatory authorities will allow.

• The best method is to collect a complete date of birth, and derive age.
• When there are privacy concerns with collecting the complete date of birth, the recommendation is to collect year of birth at a minimum.
• In cases when neither of the above can be implemented (e.g., cultural or regional considerations) then age and age unit should be collected, and date of collection should be collected or derived from the visit date.
• Use the AGETXT/CAGETXT variable in very rare cases, when only an age range or age description can be determined.

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

See Section 3.6, Timing Variables: Collection, Conversion, and Imputation of Dates, for more information.

Collection of Sex

The collection of some demographics data is useful to perform simple analyses based upon population stratification.

Collection of Ethnicity and Race

The US Food and Drug Administration (FDA) requirement is to collect ethnicity before race. A secondary analysis is often made using the phenotypic race of the subject. Collect race if required for the protocol and not prohibited by local laws and regulations.

In 2016, the US Office of Management and Budget (OMB) revised its recommendations for the collection and use of race and ethnicity data by Federal agencies. The FDA follows this directive and 

recommends the use of the standardized OMB race and ethnicity categories for data collection in clinical trials for two reasons. The use of the recommended OMB categories will help ensure consistency in demographic subset analyses across studies used to support certain marketing applications to FDA and across data collected by other government agencies.

The Race values listed in the FDA guidance on collecting race and ethnicity data (available at https://www.fda.gov/) are:

• American Indian or Alaska Native
• Asian
• Black or African American
• Native Hawaiian or Other Pacific Islander
• White

Note: For studies where data are collected outside the US, the recommended categories are the same, except for “Black” instead of “Black or African American”.

CDASH provides only 1 variable for Race. Sponsors wishing to capture more than 1 race will need to create non-standard variables to store the collection of the multiple races and map appropriately to the SDTMIG DM domain.

Race Other has been included as a free-text field to capture responses. The use of this variable is optional and should be used with caution. When submitting data to the FDA, all races must be mapped to the 5 values recognized by the FDA; providing an Other, Specify field might lead to mapping errors or difficulties. RACE is Recommended/Conditional (R/C) because some sponsors prefer to derive values that are compliant with the codelist RACE (e.g., as derived from values collected in CRACE).

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.

Collection of Special Optional Fields in Demographics

CDASHIG allows for collection of the Date of Informed Consent using the variable RFICDAT. (If a sponsor 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 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 sponsor. The SDTMIG variables DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. The CDASH field Death Date may be mapped to other SDTMIG 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.

Data Collection Scenarios

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 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 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