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I was recently asked whether it is possible to add text formatting information in ODM. The person who asked me wanted to have underlining and bold support on question texts in the CRFs. Something like: “Is your quick brown fox jumping over the lazy dog?”
Now, CDISC ODM does not suppport text formatting out of the box, as it is an exchange and archival format, and was not meant for text formatting. However, as ODM is very often the source for automated CRF creation, the question makes sense.
Also, we see that other standards in the medical world, like HL7-v3 and HL7-FHIR, do have partial support for text formatting, so it is surely we need to think about for a next version of CDISC ODM.
The first way you can add text formatting information is by using a vendor extension. This time, this is not so straightforward, as usually the text you will want to format is in a “TranslatedText” element, which is of type “simpleType” in the XML-Schema, so that you cannot add child elements to it (“simpleType” means “text content only”).
But you could for example, do something like:
<TranslatedText xml:lang="en">Is your quick brown fox jumping over the lazy dog?</TranslatedText> <my:FormattedTranslatedText xml:lang="en">Is your <b>quick</b> <i>brown</i> jumping over the <b>lazy</b> dog?</my:FormattedTranslatedText>