RE: [etmf] Groups - eTMF Std - Content Classification Layer Summary uplo

Eldin, Jamie, and Zack,

Thinking from a process POV. I have a question.

Is it important to consider the situation where the PI CV would be used across trials…and so either no Site ID or multiple Site ID might be needed?

Sorta like an IB which could go across many trials but more complicated since at the study AND site level.

Also applicable to Expedited SAE report, but in this case subject/patient ID required, right?

Or this a unique functionality for every system to figure out?

Lisa

From: etmf@lists.oasis-open.org [mailto:etmf@lists.oasis-open.org] On Behalf Of O'Keefe, James
Sent: Tuesday, February 11, 2014 5:58 AM
To: Eldin Rammell, Rammell Consulting; 'Zack Schmidt'
Cc: etmf@lists.oasis-open.org
Subject: RE: [etmf] Groups - eTMF Std - Content Classification Layer Summary uploaded

I agree this bears discussion. Though I also would want to discuss the secondary metadata categorization, if the thought is to not have it as core in an eTMF. For interoperability it is critical to have those elements replicated into eTMF, and not just reside in CTMS or other “master” systems.

Jamie O’Keefe | Director, Clinical & Regulatory Optimization Practice

Paragon Solutions | www.consultparagon.com

email: jokeefe@consultparagon.com | phone: 610-832-8110 | cell: 201-736-9443 | twitter: @jamieokeefe

From: etmf@lists.oasis-open.org [mailto:etmf@lists.oasis-open.org] On Behalf Of Eldin Rammell, Rammell Consulting
Sent: Tuesday, February 11, 2014 5:53 AM
To: 'Zack Schmidt'
Cc: etmf@lists.oasis-open.org
Subject: RE: [etmf] Groups - eTMF Std - Content Classification Layer Summary uploaded

Hi Zack,

Please include Site ID as a specific metadata discussion item for our next meeting too. Site ID is critical to data exchange for site-level documents as personnel at the site (including PI) can and do frequently change. Site ID is the one attribute that remains constant to ensure site-level documents get associated with the correct site within a TMF. This is also critical for data exchange/interoperability. The exchange of site-level TMF content from one eTMF to another eTMF only requires Site ID to ensure correct site association. For this reason, I think it should be included as core metadata. PI name, role and organization is secondary metadata that is typically maintained in a CTMS. It is only core when considering documents such as CVs, signature pages etc where you need to capture the identity of the person to whom the document relates.

Thanks.

Kind regards,

Eldin.

Eldin Rammell

Managing Director, RAMMELL Consulting Ltd

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

From: etmf@lists.oasis-open.org [mailto:etmf@lists.oasis-open.org] On Behalf Of Zack Schmidt
Sent: 11 February 2014 01:08
To: etmf@lists.oasis-open.org
Subject: [etmf] Groups - eTMF Std - Content Classification Layer Summary uploaded

Submitter's message
Slides for Mon Feb 17 9-10am PST TC meeting. Summary of content classification layer in architecture. Most of the content in the slides recaps our discussions/motions.

New items for continued discussion addresses TC comments re: Sponsor, Country, Created By terms and versioning. There are several metadata terms which we need to vote on: Clinical Trial Sponsor vs. Sponsor; Document Version vs. Content Item Version. We can cover this in the meeting.

Ideally we will be ready to make a motion to adopt the Content Classification Layer at the next meeting. Note that we can go back and make minor adjustments/fixes to the spec at a later time if needed.

Please review prior to our next meeting.

- Thanks, Zack Schmidt
-- Mr. Zack Schmidt

Document Name: eTMF Std - Content Classification Layer Summary

Description
Core Metadata, Content Model format/exchange
Download Latest Revision
Public Download Link

Submitter: Mr. Zack Schmidt
Group: OASIS Electronic Trial Master File (eTMF) Standard TC
Folder: Documents
Date submitted: 2014-02-10 17:08:05

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