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rSDV offers the best alternative option to altogether reduce onsite monitoring activities, how to maintain subject privacy in the process of collecting source documents and what 21 CFR Part 11 requires, strategies for remote review of source documents at

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Presentation on theme: "rSDV offers the best alternative option to altogether reduce onsite monitoring activities, how to maintain subject privacy in the process of collecting source documents and what 21 CFR Part 11 requires, strategies for remote review of source documents at "— Presentation transcript:

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2 Explore rSDV for Clin Ops efficiency & Cost Saving While on-site monitoring is one of the biggest cost drivers of clinical trial operations, Remote Source Document Verification (rSDV) offers the best alternative to significantly reduce onsite monitoring activities to build efficiencies, data quality and assure human subject protection. This webinar will explore the differences between rSDV and other monitoring methods, how to maintain subject privacy in the process of collecting source documents and what 21 CFR Part 11 requires, strategies for remote review of source documents at sites that do not utilize electronic medical records. Explore the great benefits of rSDV and for the types of studies it can be leveraged in a big way. This webinar covers: Remote Source Document Verification (rSDV) process Strategies & challenges in implementing rSDV Benefits of rSDV Subject confidentiality & 21 CFR Part 11 requirements CRA compliance in remote setting

3 About Our Speaker Laura LaRosa, RN MS Quality Management Strategist & Investigative Compliance specialist Date & Time: Tuesday, 27th June 2017, 11 AM -12 Noon EST | 5 PM - 6 PM CET Register here: https://www.makrocare.com/webinar-registration-on- explore-rsdv-for-clin-ops-efficiency-cost-saving


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