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Subject: OASIS Staff comments to proposed eTMF TC charter.

OASIS staff offers the following comments to the proposed charter for the OASIS Electronic Trial Master File (eTMF) Standard TC, as posted to:
While we may post major substantive comments here, the staff's right to offer comment and adjustments consistent with our rules, typo correction and otherwise does continue after the end of the member charter review period.

As always, we wish to thank the proposers and advocates of this project, for their work in bringing a potentially very useful and important open standards project into being, for the benefit of the communities of technologists and end-user stakeholders.

Comment 1.  References to contributions.  We note that there are three artifacts, from CareLex, already listed in the draft charter's scope section 1c (and mirrored in section 2h).  The proposers may wish to confirm whether any other related or similar work also can be secured as an initial contribution.

Comment 2.  Non-normative references to similar or applicable work.  Section 2a of the draft charter should include as much "landscape" information about the field into which the proposed work will be done as is possible to permit readers to contextualize these plans, and also to identify additional worker stakeholders it may be useful technical contributors to this open standards process. Thus:

(A)  As posted, this draft charter takes the position that the only relevant existing work, out in open standardization or widespread use for the functions contemplated herein is CareLex' own eTMF model.  We understand from other member comments that there may be other relevant, comparable or influential specifications that should be mentioned here, including the DIA's TMF reference model.  Listing of other specifications in this section 2a is informative, not evaluative, so we encourage the proposers to consider whether there any other additional artifacts (regardless of their merit) that should be mentioned here. The point of section 2a is to note uncritically the presence of other possible communities of stakeholders.

(B)  The draft current text describes four external specifications which he proposed CareLex contribution "utilizes" (such as RDF).  We believe this means that eTMF makes normative references to those specifications, as opposed to incorporating them within itself.  If that is the case, we suggest that the draft use the phrase "normative reference" explicitly, so as  to make that clear.  (This will help the casual reader understand that the project does not encompass rework of those other named external specifications.)

(C)  We suggest that, for convenience, external references are accompanied by a relevant URL. These charters, once published, become important persistent metadata for the project -- as well as a key marketing document for soliciting additional stakeholders -- so user-friendly pointers to various relevant artifacts are a good practice.

Comment 3.   Effect of named contributions on TC scope.   We note the following sentence in the draft charter scope section: "The scope of the TC's work is limited to technical refinements to the features defined in the input contributions and the following features and capabilities,"   By including the 3 CareLex contributions in the scope section, and adding the foregoing statement, the draft appears to be an attempt to refuse any additional functionality or improvements to the TC's output, other than as already are embodied in three named contributions from one source, plus the additions explicitly named that follow.  In layman's terms, this is a narrow approach that might be read to seek to keep the TC's output as close as possible to the CareLex inputs.  We caution that this approach is not always the best for encouraging broad stakeholder participation in open standards projects.  Alternative strategies available to the proposers include:

(A)   Including additional potential contributions within scope, if such exist, as noted in Comment 1.

(B)  Removing the phrase that seeks to bind the scope to the named inputs.

(C)  If a "quick turn" with limited functionality is deemed needed, then a more common OASIS approach is as follows:   (i) constrain the functionality of a first version by the TC, during which period only the restricted feature set is permitted, but then (ii) leave open the possibility of another future version from the same TC with greater range of scope and extensibility. That release-versioning approach can help projects avoid a "rubber-stamp" criticism.

Comment 4.  IPR, and related work versus contributions.  Please note the following matters regarding intellectual property rights:

(A)  Related to our comment 1(A) above:   we note Eldin Rammell's posted comment suggesting that some additional sources (including 21 CFR 11 and Directive EC/2001/83) also be added as "additional contributions."   We suggest that most of these probably instead belong in section 2a on "similar or applicable work."  Likely they are not "contributions," for which intellectual property rights to modify the works would be provided to the TC.

(B). Please note that, as drafted, the charter will require an irrevocable assignment of the "eTMF" name to OASIS, for purposes of its use with the future outputs of the proposed TC. 

(C)  As members are aware, under our policies, each contributor will be making certain assurances and warranties to OASIS, the proposed TC, and users of its outputs, regarding its rights to contribute each contribution, and any claims of rights against it.  The proposers may wish to prepare that information in advance, so it can be posted prior to the TC's first scheduled meeting.  We note that this proposed TC will operate under our "non-assertion" mode, which may require fairly robust licensing permissions from contribution sources.  OASIS staff is happy to help review these matters with potential contributors, if that assists a contribution.

Comment 5.  Timing.  OASIS staff generally recommends against holding the first meeting of a technical committee -- which are significant to the open membership and broad-based recruitment we pursue -- during holiday seasons.  Accordingly, we recommend that the proposed TC's first meeting date be adjusted.  This should be discussed at the upcoming conveners' meeting.

Cordially, JBC
James Bryce Clark, General Counsel
OASIS: Advancing open standards for the information society


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