Public review comments for etmf-v1.0-Metadata Vocabulary: Category 104

The classification of content within category 104 is inconsistent. Subcategory 104.11 includes content which is pertinent to a specific site ad yet content in other subcategories is also pertinent to a specific site only e.g. trial initiation monitoring report, investigator confidentiality agreement, approved consent forms.

Subcategory 104.11 includes 39 individual content types. Although it is understood that the classification schema is a technical classification and not necessarily an end-user interface classification, it would make sense to use a subdivision that resulted in smaller groupings of content, as the TMF Reference Model has done.

The classification of IRB/IEC-approved documents separately from the unapproved “master” documents is not consistent with industry practice for managing these documents. In addition, the approval of a document by an IRB/IEC is a business process which can be captured using metadata….. as defined elsewhere in the OASIS draft specification. It is not common practice to manage IRB/IEC-approved documents as a document set separately from the core original documents.

It is noted that whilst the specification and vocabulary allows for trial-level documents and site-level documents, there is no provision for country-level documents other than using the “country” metadata attribute. In other words there is inconsistency within the specification; country-level documents are classified using “country” metadata whilst site-level documents have their own subcategory (104.11).

Subcategory 104.13 is named “IRB/IEC Documents”, with an equivalent definition. However, it includes 2 documents (104.13.22 and 104.13.23) that are not IRB/IEC documents. This is inconsistent. Either the subcategory should be renamed or an additional subcategory should be created.

Eldin Rammell

Managing Director, Rammell Consulting Ltd.

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