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cdisc-org / DDF-RA

This is the repository for all code and documentation for the DDF-RA project.
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Multiple Template Support [IG] #409

Closed BSnoeijerCD closed 15 hours ago

BSnoeijerCD commented 1 month ago

USDM would become more flexible if it could support multiple templates for a single study version. It might be that some documents are extracts of the protocol and not the full document => See feature ticket #354

BSnoeijerCD commented 2 weeks ago

@dih-cdisc : updated as follows (see text in bold). + added new UML view for Documents. Do you think we need to add an ordering example like we did for eligibility criteria?

Study protocols and other study definition documents include content that is best described as "unstructured content," granting the author considerable flexibility in determining what information to include, the level of detail it will contain, the order in which it is introduced and discussed, and how it will be presented. Blocks of unstructured content can range from short text statements to many paragraphs which may also contain figures and tables.

The Narrative Content class in the UML is modeled to contain such blocks of user-defined unstructured content using HTML format. The recursive nature of this class with its attribute children provides the user the ability to add multiple named blocks of unstructured content, allowing for a hierarchy of related information to be built up and ordered by the sectionNumber and/or the previous and next attributes. The actual blocks of unstructured content are stored in the NarrativeContentItem class allowing for reuse within and between documents.

The HTML format of the text attribute and the section ordering provides the capability for organizing the information in a way that is compatible with any required document structure such as ICH M11,[4] the TransCelerate CPT, or a sponsor's internally defined template. Structured elements stored elsewhere in the model can be included and reused at any desired place in the unstructured text using the format explained in Section 4.23, XHTML Attributes.

dih-cdisc commented 2 weeks ago

The recursive nature of this class with its attribute children provides the user

The recursive nature of this class, using the "children" attribute, provides the user?

I tend to put attribute name in quotes so it is obvious which is the actual attribute name. Most of time it is obvious but it just makes sure it is clear. Being lower case they tend to get lost in the text.

BSnoeijerCD commented 2 weeks ago

The recursive nature of this class with its attribute children provides the user

The recursive nature of this class, using the "children" attribute, provides the user?

I tend to put attribute name in quotes so it is obvious which is the actual attribute name. Most of time it is obvious but it just makes sure it is clear. Being lower case they tend to get lost in the text.

Ok. updated and applied to all other attributes in the text as well.