Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Include Page
StudyEventDef Element
StudyEventDef Element

Include Page
StudyEventDef Attributes
StudyEventDef Attributes

Body:

...

Attributes:

...

Contained in:

...

A StudyEventDef represents the definition of an activity in a study where data is collected. For example, a study event may represent a set of item groups that represent data collection instruments to be completed for a subject during a visit in a study. The visit occurs as part of a study workflow, and the workflow is referenced in the study event.

Scheduled Study Events correspond to sets of data collection instruments that are expected to be completed for each subject as part of the planned visit sequence for the study. Unscheduled Study Events are designed to collect data that may or may not occur for any particular subject such as data collected for an early termination due to a serious adverse event. A common Study Event is a collection of data collection instruments that are used at several different data collection events such as an Adverse Event or Concomitant Medications log.

...