Page History

• Must match the OID attribute for an ItemDef in the Study/MetaDataVersion.
• The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate ItemOID values.

Indicator of whether this ItemGroup must appear in the study clinical data for each subject per the study protocol.

The Mandatory flag indicates that the clinical data for an instance of the containing element 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.

• When the value is "Yes", the data for each subject in the study must include an ItemData element with this ItemOID

• .

CDASH, ADaM, SDTM, and CDASH SEND Core designations. 

• Reference the appropriate specifications for

• complete

• requirements.
  • Example: CDASH: "HR", "R/C", "O"; SDTM: "Req", "Exp", "Perm".

Indicates the order in which this ItemRef appears in Metadata displays or data entry applications.

The OrderNumbers provide an ordering on the Items (within a containing element) 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.

OrderNumber must be a positive integer.

• The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate OrderNumber values.

KeySequence must be a positive integer.

• The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate KeySequence values.

A non-standard variable is one that is not defined in the SDTMIG or the underlying SDTM model of a standard referenced within the ODM document.

Permitted for any ItemRef that represents a non-standard variable in an SDTM or SEND dataset when the ODM Context attribute value is "Other"

Is not used with an ItemRef that represents a value level metadata for an SDTMIG SUPPQUAL dataset

Has no meaning for ADaM, so shall not be used for ADaM variables

• Used to indicate that an ItemRef that represent a dataset's variable has no data. Note that variables refer to both standard and non-standard/ supplemental qualifiers variables (/ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef or /ODM/Study/MetaDataVersion/ValueListDef/ItemRef). 

• A comment must be included to explain why no data is present for dataset's variables that were planned for use in the study.

• The MethodOID value must match the OID attribute for a MethodDef in this Study/MetaDataVersion.

Reference to a sibling ItemRef element that represents the unit specification for this ItemRef (defines the associated units variable).

• The sibling ItemRef element will have ItemOID=UnitsItemOID and the UnitsItemOID value must match the OID attribute for the ItemDef

• that defines the units for this Item.

Prefill value or a default value for a field that is automatically populated.

• The corresponding ItemDef must have an associated CodeList containing the items over which the repeat is to be performed.
  There may only be one ItemRef within the ItemGroupDef with Repeat="Yes".

The Role for the referenced ItemDef.

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

• must not be present unless the Role attribute is defined.

• The RoleCodelistOID must match the OID attribute for a CodeList within the Study/MetaDataVersion.
• If Role is defined, RoleCodeListOID is still optional.

• The CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion.