Oasis eTMF Standard Metadata Vocabulary Spreadsheet

1. Inclusion of the source of definitions (column F) is unnecessary e.g. CareLex, adapted from TMF-RM. This information may be useful to help reviewers during the public review stage but adds no value to the final standard.

2. The suggestion of more than 1 abbreviation for content types (column E) is inconsistent with the objective of harmonization and is also considered unnecessary. I propose that only 1 abbreviation is included in the vocabulary.

3. In the definitions (column F) there should be consistency in terms of the phraseology used. For example, ‘a description of’, ‘a documented description of’.

4. Column A – It has proven difficult for reviewers to immediately differentiate category, subcategory and content types, as all three are identified with the code [C] for Category. It would have been easier to navigate the spreadsheet if three different codes were used.

5. To facilitate interoperability, a hierarchy of category, subcategory and content type is not necessary. A classification system is already available for industry to adopt, namely the TMF Reference Model. All that is needed for interoperability of content types is the use of a unique identifier for each content type with this identifier being used consistently by adopting systems. For example, code C115777 is a Quality Plan. So long as subscribing systems use the code C115777, the category and subcategory is irrelevant, as is the positioning of the content type within a classification hierarchy. The classification should be defined by each system.

Eldin Rammell.

Rammell Consulting Ltd.

etmf-comment message