Re: [etmf] TC Admin comments on Electronic Trial Master File (eTMF) Spec

Subject: Re: [etmf] TC Admin comments on Electronic Trial Master File (eTMF) Specification Version 1.0 csprd02

Dear OASIS eTMF Standard TC members,

Per the request of OASIS staff, we have completed the Committee Specification Draft formatting edits for the OASIS Electronic Trial Master File (eTMF) Specification Version 1.0.

Tomorrow we'll have a special vote at 9am-9.30am PDT on the spec. Voting members should call-in to participate.

Call in details:

https://join.me/etmfstandard, +1.415.655.0381 Access Code: 544-009-631#

Text of resolution for TC special vote:

"I move to approve the Chair requesting that TC Administration hold a Special Majority Vote to approve Electronic Trial Master File (eTMF) Specification Version 1.0 contained in <https://www.oasis-open.org/committees/document.php?document_id=59146&wg_abbrev=etmf> as a Committee Specification. I further move that the TC affirm that changes have been made since the last public review, that the changes made are documented in <https://www.oasis-open.org/committees/document.php?document_id=59147&wg_abbrev=etmf> and that the TC judges these changes to be Non-Material in accordance with the definition in the OASIS TC Process (http://www.oasis-open.org/policies-guidelines/tc-process#dNonmaterialChange)."

For those of you who wish to review the spec package online, it can be found at:

https://www.oasis-open.org/committees/document.php?document_id=59146&wg_abbrev=etmf

The .zip package posted on OASIS at the link above will be used for our vote tomorrow. The .zip package contains the spec redline Word doc, a clean PDF version, the OASIS eTMF schema spreadsheet and the National Cancer Institute eTMF controlled vocabulary terms. I've also attached the PDF version to this email for your convenience.

The list of changes made to the spec as requested by OASIS is shown below:

Members of the eTMF TC,

TC Administration provides the following comments for the public review of the above Committee Specification Drafts. These are editorial / production items we noted during publication.

1. For section 1.1 Terminology, we added "RFC2119" to the end of the sentence as it was missing. Please include the reference to RFC2119 as a normative reference next time as well next time. Also, we didn't see that the capitalized key words were used in the spec. [Done]

2. The final two references in sect. 1.2 ([19] and [20]) are formatted differently from the first 18, leading to misalignment in both the text and HTML versions. [Done]

3. In Appendix B.2 Content Item Numbering, there is a reference to C93816. Given the way it is used it can probably be listed as a non-normative reference. In any case though, any references made should be listed in section 1.2 References. [Done]

4. Likewise please make sure that all the references in Appendix C. Glossary are listed in section 1.2

5. Appendix D uses "Oasis" in place of "OASIS" in titles and captions. [Done]

6. The captions for Figures 1, 12 and 13 are handled differently from the others. The captions themselves seem to be actual graphic elements, instead of being linked to their diagrams normally. This causes their numbering to come out wrong in the HTML. E.g. Figures 12 and 13 show up as "Figure 1" in the HTML version. [Done]

7. Figures 12 and 13 are very done in a way such that they become corrupted when we save the document as HTML. They seem to consist of multiple graphic elements overlaid. It would help if they can be done as single images that can be inserted into the doucment. [Done]

8. The "schema" spreadsheets are named with "V3". That seems confusing when the spec itself is version 1.0. We suggest using "wd03" for the working draft number instead or even just drop the version number. [Done]

Please let us know if you have any questions on any of these items.

/chet
----------------
Chet Ensign
Director of Standards Development and TC Administration
OASIS: Advancing open standards for the information society
http://www.oasis-open.org

Best,

Zack Schmidt, OASIS eTMF Standard TC Chair

On Thu, Sep 15, 2016 at 3:06 PM, Chet Ensign <chet.ensign@oasis-open.org> wrote:

Members of the eTMF TC,

TC Administration provides the following comments for the public review of the above Committee Specification Drafts. These are editorial / production items we noted during publication.

1. For section 1.1 Terminology, we added "RFC2119" to the end of the sentence as it was missing. Please include the reference to RFC2119 as a normative reference next time as well next time. Also, we didn't see that the capitalized key words were used in the spec.

2. The final two references in sect. 1.2 ([19] and [20]) are formatted differently from the first 18, leading to misalignment in both the text and HTML versions.

3. In Appendix B.2 Content Item Numbering, there is a reference to C93816. Given the way it is used it can probably be listed as a non-normative reference. In any case though, any references made should be listed in section 1.2 References.

4. Likewise please make sure that all the references in Appendix C. Glossary are listed in section 1.2

5. Appendix D uses "Oasis" in place of "OASIS" in titles and captions.

6. The captions for Figures 1, 12 and 13 are handled differently from the others. The captions themselves seem to be actual graphic elements, instead of being linked to their diagrams normally. This causes their numbering to come out wrong in the HTML. E.g. Figures 12 and 13 show up as "Figure 1" in the HTML version.

7. Figures 12 and 13 are very done in a way such that they become corrupted when we save the document as HTML. They seem to consist of multiple graphic elements overlaid. It would help if they can be done as single images that can be inserted into the doucment.

8. The "schema" spreadsheets are named with "V3". That seems confusing when the spec itself is version 1.0. We suggest using "wd03" for the working draft number instead or even just drop the version number.

Please let us know if you have any questions on any of these items.

/chet
----------------
Chet Ensign
Director of Standards Development and TC Administration
OASIS: Advancing open standards for the information society
http://www.oasis-open.org

Primary: +1 973-996-2298
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Zack Schmidt
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zs@SureClinical.net

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