Versions Compared

Old Version 2

changes.mady.by.user Sally Cassells

Saved on

compared with

New Version 3

changes.mady.by.user Jozef Aerts

Saved on

Key

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

Body:

EMPTY
(Description?, FormRef, WorkflowRef*, Alias*)


Attributes:

StudyEventOID
OID
oidrefReference to the StudyEventDef.OrderNumberinteger(optional)Mandatory(Yes | No)CollectionExceptionConditionOIDoidref(optional)Reference to a ConditionDef

Contained in:

...

oid

Namename


Contained in:

MetaDataVersion


TODO

A reference to a StudyEventDef as it occurs within a specific version of a Study. The list of StudyEventRefs identifies the types of study events that are allowed to occur within the study. The StudyEventRefs within a Protocol must not have duplicate StudyEventOIDs nor duplicate OrderNumbers.

The OrderNumbers provide an ordering on the StudyEventDefs for use whenever a list of StudyEventDefs is presented to a user. They do not imply anything about event scheduling, time ordering, or data correctness.

The Mandatory flag indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.

If the CollectionExceptionConditionOID attribute is provided, it references a ConditionDef that describes the circumstances under which data for this Study Event should not be collected.


Pagenav2