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Subject: Public review comments for etmf-v1.0-csprd01: 2 Problem Definition
Comment type [editorial ] Impact [minor] The abbreviation EDMS is more commonly used for “Electronic Document Management System” and not “Enterprise Document Management System”. The problem that this specification addresses is not limited to those with ENTERPRISE Document Management Systems. The problem affects any organization using an ELECTRONIC record-keeping, ELECTRONIC records management or ELECTRONIC document management system for clinical trial documents or records. The examples chosen to demonstrate the problem do not include the most common and most problematic issue facing the clinical trial domain, namely exchange of content between systems e.g. from CRO to sponsor. The ability to conduct searches across distributed sets of trial data is not the principal problem that stakeholders align themselves with. Eldin Rammell Principal Consultant, Rammell Consulting Ltd. |
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