Versions Compared

Old Version 8

changes.mady.by.user Marcelina Hungria

Saved on

compared with

New Version Current

changes.mady.by.user Lex Jansen

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier for the StudyEventDef element.
  • The OID attribute value must be unique within the Study/MetaDataVersion.
NamenameRequiredHuman readable-name for the study event.
  • The Name attribute must be unique within StudyEventGroupDef and StudyEventDef elements within a Study/MetadataVersion.
Repeating(Yes,No)Required

The Repeating flag indicates when this type of study event can occur repeatedly within any given subject.

When Repeating is "Yes" multiple instances of StudyEventData for this StudyEventDef may be collected for a study subject.


Type(Scheduled,Unscheduled,Common)Required

Specifies the StudyEvent Type.

The study protocol document usually specifies the planned set of study subject encounters, as follows:

Scheduled -  StudyEvent is a planned study event

Unscheduled  - Unplanned study event (for example an unexpected adverse event that occurs between planned visits.

Common - A set of study activities that occur for as part of all subject encounters within a study.


CategorytextOptionalThe Category attribute is typically used to indicate the study phase appropriate to this type of study event. Examples might include screening, pretreatment, treatment, and follow-up.
CommentOIDoidrefOptionalReference to a sponsor comment or external document relevant to this StudyEvent definition.