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Description

Demographics (DM) is a special-purpose domain that includes a set of essential standard variables 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 collection variables to collect the components of birthdate (e.g., BRTHDD, BRTHMO, BRTHYY); therefore, limited elements of 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 typically collect the age or date of birth of the subject but may collect both if required by the study. In multiregional studies, applicants may need to comply with local regulations. 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.

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.

Collection of Sex

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

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

TIG collection standards allow for collection of the Date of Informed Consent using the variable RFICDAT. (If 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 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 applicant. The tabulation variables DTHDTC and DTHFL are mapped to the DM domain during the dataset creation process. The collection field Death Date may be mapped to other tabulation domains (e.g., DS), as deemed appropriate by the applicant.

Data Collection Scenarios

This section describes 2 different data collection scenarios for the demographics domain. It is up to the applicant 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