We have just witnessed some of the greatest performances of the Sochi Winter Olympics. In the first-ever Olympic men’s slopestyle ski competition the US team swept gold, silver and bronze medals capped by Joss Christensen’s stunning switch right triple cork 1260. Another great moment came in the games when Yuzuru Hanyu won Japan’s first men’s gold medal in figure skating after setting a world record with 101.45 points in the short program. Then there was skater Jeremy Abbott, who after falling and crashing into the wall, got up and finished his program with courage and grace, spurring an outbreak of spirited applause.
Behind such epic Olympic moments is a great deal of preparation. Just like an athlete, data managers need the right preparation to reach peak performance. This includes understanding new FDA regulations around Part 11 electronic records and signatures as well as the latest guidance that embodies the agency’s current thinking and clarifications ─ all of this impacts what we do as data managers and how we do it. Nowhere is this more evident than with FDA’s guidance on risk-based monitoring finalized last August. In it the agency’s preferred monitoring approaches are explained with a case made for an upfront assessment of risks and a solid monitoring plan to support it.
When considering the implications for data managers, it becomes clear that making the move to risk-based monitoring can elevate the role to new heights. Risk-based monitoring with reduced Source Document Verification (SDV) and central monitoring puts greater emphasis on the use of study data to inform researchers’ actions. Analytics reveal how well sites are performing and point where to focus your efforts. With industry groups and the FDA backing a smart approach to monitoring along with increased reliance on data analytics – this is truly monumental!
FDA’s Guidance for Industry: Electronic Source Data in Clinical Investigations
Then there is FDA’s Guidance for Industry: Electronic Source Data in Clinical Investigations, finalized last September. From this we learn what constitutes a source data originator; how data managers can support the audit trail, and ways source data can be captured in an electronic case report form (eCRF). This guidance also outlines the responsibilities of clinical investigators in regard to reviewing and retaining electronic data. It also presents important information about the use and description of eClinical systems in clinical trials.
To help data managers understand recent regulatory changes and the eClinical innovations that support them, I am holding a live webinar, Primer for Data Managers on 2013 FDA Guidance and Regulations in an Age of eClinical Innovation, on March 18th. We will take a close look at the latest guidance and regulations and explore the implications on the data management role. We will even learn what old habits to kick (100 percent SDV) and some new ones to adopt such as getting involved in the authoring of joint monitoring/data management plans. We will also look at the changing skill set of data managers and see what is most in demand (spoiler alert: skills are both task-driven and strategy-driven). We’ll touch on some of the hottest trends driving change such as complex study designs, eClinical systems that allow direct entry into eCRFs, communciation methods that help to keep trials on track, and eSource including apps on tablets, iPads and other devices used by research sites for data collection. I confess that I am a data management nerd – I love these topics! But I will also try to leave time for you to ask your own questions.
Please join me for this informative webinar and prepare for success in our rapidly evolving field.