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Subject: RE: [etmf] Groups - eTMF Std - Content Classification Layer Summary uploaded
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 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 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 Submitter's message
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