Public review comments for etmf-v1.0-csprd01: 3.1 OASIS eTMF Standard Benefits

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

Comment type [editorial]

Impact [minor]

Please change “The high level benefits of a standard for interoperable clinical trial information exchange…” to “The high level benefits of a standard for interoperable clinical trial master file content and metadata exchange…..”. The scope of the standard is limited to the trial master file and not all clinical trial data. The original statement is ambiguous.

The TC should reconsider including as a specific benefit of this standard “Streamline agency compliance with standards-based exports and eSubmissions”. In a global environment, it is a potentially a dangerous statement that agency compliance will follow adoption of this standard for eTMFs.

Eldin Rammell.

Principal Consultant, Rammell Consulting Ltd.