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Description

The CDASHIG Demographics (DM) is a special-purpose domain that includes essential data collection fields a set of essential standard variables that describe each subject in a clinical study.  The 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 collection 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 tabulation variable BRTHDTC.  This 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 applicants may collect the age or date of birth of the subject. In multiregional studiesmultiregional studies, sponsors 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 When only age is collected, the sponsor 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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