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Subject: Proposed Charter for OASIS Electronic Trial Master File (eTMF) Standard TC

I would like to make the following comments on the proposed charter for the OASIS Electronic Trial Master File (eTMF) Standard TC:


1.    Statement of purpose – remove the term “BioPharma”. Inclusion of the term BioPharma would exclude non-commercial trials (i.e. investigator-sponsored & academic-sponsored trials) and would exclude the investigator site file.

2.    Problem to be solved – change “research” to “record-keeping”. It is not so much the research that is paper-based but record keeping systems.

3.    Scope of work – add TMF Reference Model to the list of published sources. The TMF Reference Model developed by the DIA Records & Document Management Community contains a published vocabulary which will be used as a reference point.

4.    Input – include TMF Reference Model v2.0 published June 25 2012 as an input source. To ensure alignment with this model widely used across industry, it will inevitably be used as an input.

5.    Scope of work – question the use of the term “technical refinements”. The implication is that the list of artifacts / scope of the CareLex Content Model is correct and aligned with the DIA Reference Model, for example. If this is not true, the charter as currently worded would not permit modifications to be made (only technical changes). Therefore, the scope should include validation of the scope of eTMF content model and level of granularity needed.

6.    Out of scope – remove “extending beyond the scope described above”. Unnecessary statement as this is a list of items out of scope!

7.    Anticipated audience – add the word “document” to 4th bullet. It needs to be made clear that the scope is clinical trial documents and not clinical trial electronic content in general (e.g. patient data, patient listings, etc).

8.    Anticipated audience– remove the term “BioPharma” (see item 1 for rationale).

9.    Initial contributions - include TMF Reference Model v2.0 published June 25 2012 as an initial contribution. Whilst it was used as a source for the CareLex model, it is also in itself an input for the OASIS TC.

10.  Initial contributions – remove CareLex eTMF Standards logo. I cannot see the relevance of this logo to the OASIS initiative; it is a CareLex developed and used logo, giving the impression that this is a CareLex initiative.





Eldin Rammell

Managing Director, RAMMELL Consulting Ltd

Office: +44 (0)844 8844926  Direct dial: +44 (0)1905 617 716  Mobile: +44 (0)7940 859721






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