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An ItemDef describes a type of item that can occur within a study. Item properties include name, datatype, range, or codelist restrictions, and several other properties.
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Note: The DataType attribute specifies the allowable values and the intended use of the corresponding value elements, but not necessarily how systems will store them. The receiver is expected to preserve the value and precision of the data and can use the ODM-specified datatype to determine the best representation of the data in their system.
The Length attribute is optional for all datatypes.
Note: In ODM v1.3.2 the Length and SignificantDigits attributes were used to express the requirements for the receiving system. In ODM v2.0 the meaning of the Length attribute remains the same for the text and string datatypes, but has been changed for the numeric datatypes and is now optional for all datatypes. The SignificantDigits attribute has been removed. If DataType is text or a string and the Length attribute is provided, Length=N indicates that the receiving system be able to process and store all text string values of length less than or equal to N. All characters are allowed in text string values.
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Note: Data characters that are not included in the encoding character set for a particular ODM file must be represented using XML entities or character references. For example, Æ could be represented as "Æ".
The CommentOID attribute references a CommentDef element that may carry submission information as described in the SDTM (available at https://www.cdisc.org/standards/foundational/sdtm).
The ItemDef child element Alias may be added to represent an alternative name for the ItemDef, for example setting with Context="SASFieldName" for SAS dataset variable names.
Note: In the ODM model, all internal keys are assumed to be unchangeable. This was done to make the audit trail issues work: If the SubjectKey in the model were the actual external subject identifier (or randomization ID) of a patient, and that value is sent incorrectly in one ODM file, there would be no way to correct the mistake in a follow-up file. In doing this, we intend that the external subject keys (and other externally visible key variables) should be defined as Items in the metadata. Thus they can be modified through normal modify/audit mechanism. Although this solves the problem of supporting modification of study keys, it leaves the user without a way to identify which ItemDefs have special meaning or what the meaning is. The most obvious place where this is a problem is in matching up patients when loading data from an external source. If you cannot find the patient ID, how do you do the matching? The answer is to create an Alias child element of ItemDef to provide an alternative name by, for example, setting with Context="SDSVarName" and Name="USUBJID". Setting Context to SDSVarName is a convention that can be used to tag the Item with a business meaning. Rather than try to enumerate all possible meanings in the ODM model, the Data Exchange Standards Team thought it best to rely on the set of variable names defined in the CDISC SDTM; this list covers the core variables used in managing clinical data. Software that is processing an ODM-compliant XML instance can therefore use specific Names when Context="SDSVarName" to identify standard, frequently used variables. The use of this Context value is restricted to variables defined in the SDTM model. In tagging a variable, you are identifying it as matching the SDTM definition for that variable. A partial list of commonly used values includes:
See the SDTM and SDTMIG for more information about SDTM variables. |
The Question element contains the text shown to a human user when prompted to provide data for this Item.
The RangeChecks constrain the acceptable values for items of this type.
The CodeListRef (if present) constrains the acceptable values for items of this type to be members of the referenced codelist.
Note: Items do not repeat within an item group.
The Origin attribute in ODM v1.3 has been replaced by an Origin element attached to the ItemRef. This allows a different Origin to be specified depending on where the Item is used.
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