Bryan McDowell,<\/strong> M.Sc., M.B.A.<\/strong><\/strong><\/strong> – VP, eCOA Science and Consulting at Clario<\/p>\n\n\n\n In a recent LinkedIn poll<\/a>, we asked our followers about their awareness of new eCOA-related regulatory guidance published this year. With over 140 responses, more than half indicated low to fairly low awareness. In a recent webinar<\/a>, Bryan McDowell, Clario\u2019s VP of eCOA Clinical Science and Consulting, delved into pivotal questions from clinical trial teams. Responses have been edited for clarity.<\/p>\n\n\n\n A:<\/strong> There has been a shift in mindset regarding the necessity of screenshots as we transition from paper to electronic records. While there was high demand for screenshots in the past, with various modalities and devices emerging, screenshots have become less important. The need for screenshots varies across countries and institutions. Regulatory authorities and ethics committees may review translations or IT implementations, but these processes shouldn’t rely solely on screenshots. Complex tools and devices make providing screenshots for all scenarios unrealistic. Instead, demonstrating proper implementation processes can alleviate the need for screenshots.<\/p>\n\n\n\nQ: Are screenshots for eCOA a critical part of IRB submission?<\/h2>\n\n\n\n
Q: How does the FDA’s Patient-Focused Drug Development guidance Part 4 address the issue of patient burden and how can we avoid missing data? What are the key differences between the FDA and the Patient Focused Guidance series and the FDA’s PRO guidance that came out in 2009?<\/h2>\n\n\n\n