Public review comments for etmf-v1.0-csprd01: 6.1.2 OASIS eTMF Exchange Package

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

Comment type [technical]

Impact [major]

Whilst the exchange of content between systems as a collection of folders via a standard ZIP file may be appropriate in some use cases, the draft specification does not appear to accommodate the more usual use case required by industry, namely the on-going, real-time exchange of content between eTMF systems e.g. from CRO eTMF to sponsor eTMF, or from investigator site eTMF (eISF) to sponsor eTMF. Exchange via ZIP files in these scenarios is not a practical approach.

 

As a general comment, the draft specification does not appear to address anywhere the typical use cases that the standard is expected to operate within.

 

The use of ZIP compression software is not universally accepted in regulated environments as it is often very difficult to validate the end-to-end process (there being many different “flavours” of compression and decompression tools).

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.