Public review comments for etmf-v1.0-csprd01: 5.1.1.4 Rules to Modify/Create Classification Categories Entities

["Eldin Rammell, Rammell Consulting" <eldin.rammell@rammell.com>]

Comment type [technical]

Impact [major]

It is not understood from the text provided how allowing Organization 1 and Organization 2 to add their own organization-specific Categories, Subcategories and Content Types, each with completely numbers to identify them, will facilitate interoperability between those 2 organizations. Interoperability, in this scenario, would only be possible after a manual mapping of the content types between the two organizations…. a scenario that this specification is aiming to avoid.

Given that the taxonomy and vocabulary is based upon international, published regulatory requirements for clinical trial master file content, uses the NCI vocabulary, AND provides for the use of optional labels and other metadata to describe documents and records, the ability for an organization to add their own Categories, Subcategories and Content Types is considered unnecessary, undesirable and contrary to the objectives of an interoperability standard. Where a gap in the Categories, Subcategories and Content Types provided within the specification is identified by industry over time, the specification/standard should be revised accordingly to bridge the gap and so ensure ongoing interoperability and standardization. This is the approach adopted successfully by the TMF Reference Model where multiple individual organization-specific documents can be mapped to entities within the TMF Reference Model (artifacts) but the underlying taxonomy remains constant.

Eldin Rammell.

Principal Consultant, Rammell Consulting Ltd.