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Subject: Comments Electronic Trial Master File (eTMF) Specification Version 1.0
Dear OASIS, I really think this model would benefit from defining detailed use cases. For example: · Ongoing / periodic transfer of documents from a CRO to a sponsor · Final transfer of documents from a CRO to a sponsor for a completed study · Transfer of documents originating at a sponsor to a CRO · Export of a final study for archiving in accordance with records management policies · Transfer of documents from a regulatory EDMS to an eTMF · Upload of site documents (or vendor documents, etc.) · Transfer of a paper TMF to an eTMF · Transfer of documents from a legacy eTMF to a new eTMF · Export of documents to support regulatory publishing · Etc. Regards, Kathie Kathie Clark | Director, Product Management
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