Adverse Event Subcategory

The Adverse Event sub-domain is intended for those involved in safety related activities; such as detection, evaluation, follow-up and reporting. This includes…

The time at which and adverse event starts.

The day of the week an adverse event began.

The date and time an adverse event began.

The calendar date on which an adverse event starts.

One or more sponsor defined characters used to identify, name, or characterize the adverse event.