Public review comments for etmf-v1.0-csprd01: 4.1 Description of the

Comment type [editorial]

Impact [minor]

The following statement is misleading: “healthcare and life sciences standards organizations such as HL7, CDISC, FDA, NIH and others”. FDA and NIH are not standards organizations. Please re-word. Suggestion: “healthcare and life sciences standards organizations such as HL7, CDISC and other healthcare/life sciences organization such as FDA, NIH and others”

“The DIA TMF RM provides a set of terms for the industry through its published spreadsheet.” The TMF RM is more than just a set of terms. Through its use of zone, section and artifact hierarchy, it provides a taxonomy for trial master file content. Suggestion: “The DIA TMF RM provides a set of terms and taxonomy for the industry through its published spreadsheet”.

“”…providing a path forward to a global ISO standard…”. The development of an OASIS standard to an ISO standard is outside the scope and remit of the OASIS TC and is not described within the scope and objectives of this draft specification. Please remove this reference to a global ISO standard for eTMF interoperability.

“This layer is based upon the W3C RDF/XML, which represents resources through the web, can be easily searchable, widely used, and allows sharing electronic information through the cloud.” This sentence does not make sense grammatically (e.g. “can be easily searchable”). In addition, adoption of the standard will not limit sharing electronic information vis “the cloud” only; this is confirmed in Section 2. Use of the term “the cloud” adds no value and introduced ambiguity.

Eldin Rammell.

Principal Consultant, Rammell Consulting Ltd.

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