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Collection of Age vs. Date of Birth
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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.
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Date of birth should be implemented such that incomplete dates may be entered, as allowed by the EDC system. Jira
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. Jira
Collection of Ethnicity and Race
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- 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.
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