ODM-58 - Getting issue details... STATUS
Since ODM v1.3.0, there have been 2 forms of the ItemData element (the element used by the ODM for transmitting clinical data item values): untyped and typed forms. The ItemData element, present in all previous ODM versions, is the form used for untyped data transmissions. The ItemData[TYPE] elements are the form used for typed data transmission.
The ODM schema for Version v1.3.2 includes the following ItemData[TYPE] elements:
| ItemDataAny |
| ItemDataString |
| ItemDataInteger |
| ItemDataFloat |
| ItemDataDate |
| ItemDataTime |
| ItemDataDatetime |
| ItemDataBoolean |
| ItemDataDouble |
| ItemDataHexBinary |
| ItemDataBase64Binary |
| ItemDataHexFloat |
| ItemDataBase64Float |
| ItemDataPartialDate |
| ItemDataPartialTime |
| ItemDataPartialDatetime |
| ItemDataDurationDatetime |
| ItemDataIntervalDatetime |
| ItemDataIncompleteDatetime |
| ItemDataIncompleteDate |
| ItemDataIncompleteTime |
| ItemDataURI |
All typed data value elements carry their data value as the element's PCDATA content. For example, an ItemDataInteger element would appear as:
<ItemDataInteger ItemOID="ID.114">100</ItemDataInteger>
Use of the ItemData[TYPE] element form permits the application receiving the ODM XML file to validate the ClinicalData when parsing the ODM file.
The ItemDataAny element is provided as an escape mechanism for transmitting clinical data values that do not have the correct DataType for the corresponding ItemDef. Receiving applications are not required to load the data values transmitted using ItemDataAny elements into the corresponding database field.
Typed and untyped data must not both be used within a single ODM file.
Note: In untyped data transmission, special characters such as ' , " , < , > , & have to be escaped. In the typed data transmission form, these can be transmitted either within a CDATA block, or escaped.
<ItemDataString ItemOID="ID.115">
<![CDATA[
The five special characters that must normally be escaped are ' , " , < , > , &
]]>
</ItemDataString>
Systems that generate or receive ODM files are encouraged to provide typed data transmission.
Systems that receive ODM clinical data files but do not normally support 1 or more of the datatypes listed in this section should accept clinical data of the unsupported types as text. In cases where these systems transmit clinical data by generating a new ODM file with the unsupported type, the generated file must include the original datatype information.
For example, if a system that does not normally support hexBinary or hexFloat datatypes receives an ODM XML file containing data for an Item defined as having datatype "hexFloat", the clinical data for the Item may be stored as Text. If that system generates an ODM file that includes data for that item, the ItemDef must still define the datatype as hexFloat.