Typically, different
people own different tasks in the workflow. However, ownership can
vary depending on the company, and a person might perform tasks in
more than one capacity. The following user definitions explain the
typical owners and their tasks in the workflow.
Clinical administrator
defines and manages
data standards. Analyzes how data standards are implemented by programmers.
Data standards administrators can view trends about how a domain is
used by programmers. These trends might identify a new column to add
to a domain, or point to a custom domain that you should promote into
the standards.
Trial manager
defines studies and
submissions, defines authorization, and sets the defaults that programmers
use when defining content. Setting defaults ensures that programmers
use the correct version of the data standards.
Clinical programmer and data manager
creates standard and
custom domains, writes jobs to extract and transform data into domains,
and writes jobs to validate compliance of domains to a data standard.
For tasks that are typically
performed by clinical programmers or data managers, see SDTM Domains.