ItemRef

Body:

Attributes:

Contained in:

A reference to an ItemDef as it occurs within a specific ItemGroupDef. The list of ItemRefs identifies the types of items that are allowed to occur within this type of item group.

The ItemRefs within a single ItemGroupDef must not have duplicate ItemOIDs nor OrderNumbers.

The OrderNumbers provide an ordering on the Items (within a containing Item Group) for use whenever a list of Items 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 an instance of the containing item group would be incomplete without an instance of this type of item. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.

The KeySequence (if present) indicates that this item is a key for the enclosing item group. It also provides an ordering for the keys.

The MethodOID references a MethodDef used to derive the value of this item.

The UnitsItemOID references an ItemDef that defines the associated units variable.

The Role attribute provides a single role name describing the use of this data item.

If the Role is defined by a standard terminology, RoleCodeListOID may be used to reference a CodeList that defines the full set roles from which the Role attribute value is to be taken. This attribute should not be present unless the Role attribute is defined. If Role is defined, RoleCodeListOID is still optional.

If the CollectionExceptionConditionOID is provided, it references a ConditionDef that defines the circumstances under which collection of the Item may be omitted, i.e. when the FormalExpression evaluates to True. For example, a data collection instrument designed to collect data for an item 'IsPregnant' for an item group 'InclusionCriteria' may be omitted for male subjects. The referenced ConditionDef would be defined as illustrated below. When the FormalExpression evaluates to True, the Item with OID IG.ISPREG need not be collected.

<ItemGroupDef OID="INCLUSION" Name="Inclusion Criteria" >
		   ...
		   <ItemRef ItemOID="IDef.GENDER" Mandatory="Yes"/>
		   <ItemRef ItemOID="IDef.ISPREG" Mandatory="Yes" CollectionExceptionConditionOID="CECID.ISMALE"/>
</ItemGroupDef>

<ConditionDef OID="CECID.ISMALE">
     <TranslatedText xml:lang="en">Do not collect data for Male subjects </TranslatedText>
	 <FormalExpression context="PL/SQL">
	 	  INCLUSION.IDef.GENDER = 'Male'
	 </FormalExpression>
</ConditionDef>