Amendment Document Content References

[BSnoeijerCD]

Study Changes may refer to one or more sections of the (protocol) document. These references are not handled by the DocumentContentReference class. However, we need to reconsider whether a direct to narrativeContent or another method of referencing would be better.

Item	Ticket
Model	#496
CT	#497
API	#498
Rules	#500
IG	#499
Test Data	#501

[BSnoeijerCD]

@dih-cdisc @ASL-rmarshall @EMuhlbradt @czwickl See below suggestion for change based on this issue:

[dih-cdisc]

Just thinking about pointing from the structured content to the document (StudyChange -> NarrativeContent). Currently we only point in to the structured content from the document.

Also pondering content shared across documents, so ...

If we reversed the direction of the relationship, so from NarrativeContentItem to StudyChange (this content was changed as a result of this change to the study definition) [the Blue Arrow] an application could navigate (the Red paths] to the respective sections impacted in multiple documents.

Have a think.

[BSnoeijerCD]

@dih-cdisc @ASL-rmarshall Options are: 1) from change perspective: ChangedSections will point to the corresponding sections in the NarrativeContent class. The context of this narrativeContent class then indicates the document we are looking at. So that also covers changes in different sections of different protocols. 2) from content perspective: NarrativeContentItem will point to StudyChange indicating when and why changed including the rationale. This is also within the context of the corresponding document. 3) Keep the DocumentContentReference class since it also documents changes to document sections that might not be included any more in the current version or section numbers are changed in the current version. Although this is more from a text perspective we still can link via the specified section numbers/titles. However, we are now lacking the specific document id here to identify the document that is changed. For this we could add (optionally) a reference to the document that is changed.

[BSnoeijerCD]

Hi @ASL-rmarshall @dih-cdisc @czwickl @EMuhlbradt As promised: see instance diagram below with corresponding discussion points included as comments.

[BSnoeijerCD]

[ASL-rmarshall]

Here's my attempt. I've worked on the assumption that each StudyChange references the section that is the result of the change ("the referenced section looks like it does because of the change that has been applied"), which is part of the document version that documents the StudyVersion that contains the amendment. The instance diagram shows three study versions (first version at the top, third at the bottom), with StudyVersion content on the left and corresponding documentation content on the right:

[BSnoeijerCD]

@EMuhlbradt @ASL-rmarshall @czwickl @dih-cdisc As discussed during scrum today: we will only add 1 relationship from the DocumentContentReference class to the StudyDefinitionDocument class named: appliesTo This will be a required 1 to 1 relationship.

[BSnoeijerCD]

Final UML view:

[EMuhlbradt]

@BSnoeijerCD @ASL-rmarshall @dih-cdisc: Relationship added in 3-8-0 release in github. @czwickl