Re: [oasis-charter-discuss] Proposed Charter for OASIS Electronic Trial Master File (eTMF) Standard TC

[Chet Ensign <chet.ensign@oasis-open.org>]

Hi Eldin, 

One comment on your comment [7] about additional contributions. Section (2)(h) is for listing content 

In the context of work at OASIS, "contribution" has a specific meaning as laid out in our Intellectual Property Rights Policy (https://www.oasis-open.org/policies-guidelines/ipr). Specifically, when someone contributes a work to OASIS, they assert that they have rights to provide OASIS with a non-exclusive license to reuse the contribution in the work of the TC and, by contributing, that they are doing so. 

Within the TC, TC members can, for example, upload documents to the TC's document repository and, in so doing, contribute it. From outside the TC, parties can contribute work by sending it to the TC's -comment mailing list. 

I don't think you mean that these documents would be contributed in that sense, correct? Assuming not, I think the better place for them is (2)(a) Similar or applicable work. They are specific works the TC will pay attention to, take into account, etc. etc. - but not works that someone intends to contribute to OASIS. 

Does that make sense? 

Thanks, 

/chet 

On Fri, Nov 8, 2013 at 12:32 PM, Eldin Rammell, Rammell Consulting <eldin.rammell@rammell.com> wrote:

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

 

[1]      Problem to be solved. Insert before 2^nd sentence: “For those with access to CMS systems, a method to exchange content via cloud services is needed.”

 

[2]      (1)(c) Scope of work. Additional sentence at the end of point (1): “We will seek input during the initial stages of work from key industry groups including, but not limited to, CareLex, clinical trial sponsors, Document & Records Management DIA Community, NCI Thesaurus, SAFE-BioPharm, technology vendors, and TransCelerate BioPharma. Input will be incorporated into the general statement of need.”

 

[3]      (1)(c) Scope of work. Include “TMF Reference Model v2.0” in the list of published sources in (3). List sources in alphabetical order.

 

[4]      (2)(a) Similar or applicable Work. Number the listed works i.e. CareLex eTMF model is (i)

 

[5]      (2)(a) Similar or applicable Work. Item (ii) in the list is: “The TMF Reference Model contains a classification hierarchy of clinical trial artifacts which is based upon the principal regulatory requirements for trial master file content in the three ICH regions (USA, EU and Japan).”

 

[6]      (2)(h) Initial Contributions. Include URL for the TMF Reference Model i.e. http://www.diahome.org/en-GB/News-and-Publications/Publications-and-Research/EDM-Corner.aspx

 

[7]      (2)(h) Initial Contributions. Add the following to the list of initial contributions:

 

·         US Code of Federal Regulations, 21CFR11, Electronic Records, Electronic Signatures

·         ISO 32000 / PAdES specification

·         SAFE-BioPharma published standards for digital signatures

·         FDA guidelines for digital signatures (reference unknown)

·         European Commission Directive 2001/83

·         European Commission Directive 2005/28

·         EMA Reflection paper on GCP compliance in relation to trial master files, Feb 1, 2013

 

Regards,

Eldin.

 

 

 

 

 

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/chet 
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Chet Ensign
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