Public review comments for etmf-v1.0-csprd01: 6.1 OASIS eTMF Data Model

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

Comment type [editorial]

Impact [minor]

From the first sentence “The OASIS eTMF data model represents a single instance of an eTMF content model for a single clinical trial.”, it is not clear whether there can only exist one content model for a single clinical trial. On any given clinical trial – especially long-term trials – it may be necessary to revise the content model, for example, to change an object label. There would therefore exist more than one content model for a given clinical trial.

 

This section (4^th sentence) implies that export to XML and PDF is required for 21CFR11 compliance. My understanding is that the requirement from the FDA is not a requirement contained within the Code of Federal Regulations Chapter 21, part 11. Furthermore, the requirement pertains ONLY to content that is required to be submitted to the FDA electronically as part of a submission. The statement is therefore misleading. In addition, it is not understood why requirements of the FDA are specifically cited within this draft specification when it is intended to be a global standard.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.