Public review comments for etmf-v1.0-csprd01: 5.1 Classification Categorization

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

Comment type [technical]

Impact [major]

The proposed classification schema, including content entities, hierarchy and numbering system are all helpful to promote and facilitate standardization of content across eTMF technologies. However, this level of complexity is unnecessary SOLELY for interoperability and data exchange, which is the remit of this OASIS Technical Committee and specification. The specification provides for a unique Category Code, representing an artifact, document, record or data item described in the NCI Thesaurus Enterprise Vocabulary Services. The inclusion of Primary Category, Subcategory and Content Type – whilst giving semblance of alignment with the TMF Reference Model and encouraging standardization of indexing – is unnecessary for interoperability and content exchange and adds unnecessary complication. Furthermore, it may prevent vendors that currently have an eTMF data model that does not include this approach from adopting the standard i.e. it introduced an unnecessary barrier.

For example:

A “Trial Team Member CV” needs only to be characterized using the classification code C115489. The category code T100.11.11 is not necessary for data exchange, neither is the Primary Category (Trial Management), Subcategory (Trial Team) or Content Type (Trial Team Member CV). If an artifact with classification code C115489 is exported from System A to System B, the import API of System B will know how to manage the object by virtue of the fact that it has classification code C115489 i.e. it will be handled as a Trial Team Member CV. This allows for complete flexibility of eTMF taxonomy by allowing vendors to choose any approach for content entities and hierarchy.

Implementation of the full proposed content entities, hierarchy and numbering system could present a significant barrier to adoption for many eTMF solution and should therefore be avoided in a global standard unless it is critical to the objective of the specification (interoperability and exchange). Only a unique content identifier is critical for interoperability and exchange, together with a standard interpretation of the identifier, as provided for by NCI.

Eldin Rammell.

Principal Consultant, Rammell Consulting Ltd.