Comments Electronic Trial Master File (eTMF) Specification Version 1.0

I note that the draft specification does not appear to include attributes that would assist in the long-term retention, preservation and ultimate disposal of the record. For example, the British Standard BS 23081 ‘Metadata for Records’, the UK National Archives ‘Records Management Metadata Standard’ and the Australian Government ‘Metadata Standard’ all include attributes for archiving, retention and disposal. Whilst there is not a global/international standard or vocabulary equivalent to NCI for such terms, I would suggest including some relevant attributes from PREMIS which is the nearest thing you can get to a standard. The PREMIS Data Dictionary for Preservation Metadata is “the international standard for metadata to support the preservation of digital objects and ensure their long-term usability” As an absolute minimum, the specification should include use of a hash sum to monitor record integrity!

The retention times themselves would not be appropriate to include but there should be mandatory attributes that support retention/disposal management as well as digital preservation.

It is noted that another respondent refers to ‘use cases’ for the eTMF Standard, including the exchange of eTMF content to a location for long-term archiving and preservation. Such a ‘use case’ would require retention, preservation and disposal-related attributes to be effective.

Eldin Rammell,

Managing Director, Rammell Consulting Ltd.

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