If all classifications are numbered in this way, the need for a standard vocabulary or text-based term seems only so that humans can discuss the classifications. If this is the case, why not use the TMF RM terms as the starting point?
Section 5.1.1.2 "Category Name, which is used...for compliance with other standards"
What other standards prescribe use of specific category names? Suggest adding a standards reference here.
Isn't the category name for this category code "Trial Operations"? Figure 6 does not match this text nor the vocabulary worksheet
Section 5.1.1.2 "Numbers for sub-categories start..."
I believe the nesting and division schemes requires further clarification. Its unclear to me why the example 142.23.67 is valid.
Section 5.1.1.4 "In the first case, the details of an Organization-specific..."
Is the creation of organization-specific categories or content types really necessary scope? It seems counter to the purpose of this specification.
Section 5.1.1.4 "In the second case, the Domain-specific..."
Explanation of new domain-specific categories or content types could use some clarification - particularly an example for what is referred to as a 'Content Model'.
Section 5.2.1 "In the context of a Content Management System.."
In the introductory section of this document, it was stated at EDMS systems were currently used. Suggest being consistent here, or updating the introductory section.
Section 5.2.1 "Every digital document..."
Is "digital content item" used interchangeably with "digital document" and "computer file" throughout? If this assumption is not explicitly stated anywhere, it would help to do so, or to use one consistent term throughout.
Section 5.2.1 (page 18) "Data Properties are...without explicit relationships defined"
Are metadata items precluded from having relationships to one another (such as Study & Study Site)?
Section 5.2.1.1 2nd paragraph, "...included with every entity term"
"entity term" is used here for the first time. It would help to define and/or provide example(s).
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