[Date Prev] | [Thread Prev] | [Thread Next] | [Date Next] -- [Date Index] | [Thread Index] | [List Home]
Subject: RE: [etmf] Groups - eTMF Std - Content Classification Layer Summary uploaded
In this context, what is the impact if a study has multiple sites? This seems very much a possibility. Mead 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
|
[Date Prev] | [Thread Prev] | [Thread Next] | [Date Next] -- [Date Index] | [Thread Index] | [List Home]