Public review comments for etmf-v1.0-csprd01: B.2.1 Core Metadata

Comment type [technical]

Impact [major]

The meaning of the term “Country Code” is not understood. Does this relate to the sponsor of the clinical trial or the original of the content? Typically, country is not associated with all trial master file documents/records, but only content that is site-specific or country-specific. For example, a clinical trial protocol or investigator brochure would not have a country code associated with it. Please clarify why Country Code is core.

It is not understood why Business Process, together with the associated terms, is categorised as Core Metadata i.e. applicable to every content item. It is agreed that where Business Process is used, there needs to be a common standard to facilitate data exchange/interoperability but it is not clear that every content item has associated business process attributes, especially so for eTMF solutions that do not incorporate workflow functionality.

In addition, the inclusion of ‘Person Name’ and ‘Person Role’ as mandatory items could be problematic. These are typically free text fields, resulting in the potential for errors, duplication etc. Username is required as a term for Created By and Modified By; would this be a more acceptable term?

It is not understood why Subject Identifier is included as Core Metadata i.e. applicable to every content item. This term will only be applicable for subject-specific content e.g. case report forms, or AE reports.

The inclusion of a specific field ‘Digital Signature’ is not understood. If a document has been digitally signed, is the specification requiring that metadata about the digital certificate is manually entered into a digital signature field. The specification needs to provide extended text to explain how this term is to be used and what its purpose it.

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.

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