Public review comments for etmf-v1.0-csprd01: Appendix C. Glossary

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

Comment type [editorial]

Impact [minor]

There does not appear to be any rationale for including a definition of EDMS that originates from the State of North Dakota. In addition, whilst they appear to have defined “Electronic” DMS, the web page cited is headed “Enterprise” DMS. This ambiguity is likely to cause confusion. It is recommended that a definition is included that originate from a source relevant to the topic, for example a Document Management ISO standard. The definition provides does not actually include the word “document”!

 

The definition of eTMF appears to limit the scope only to “pharmaceutical clinical trials”. Wikipedia is not a suitable source for an authoritative specification such as this. It is recommended that a definition be provided based on a specific regulatory agency definition.

 

The eCTD is not an FDA specification. The eCTD is a global specification produced by ICH, applicable to all ICH agencies. Please provide the ICH citation rather than a US-centric citation.

 

Please provide an alternative citation for NCO other than Wikipedia.

 

Please include ‘Trial Master File’ with the ICH definition.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.