Compliance In Focus

What is the ultimate goal for every clinical trial?  High-Quality Data that proves safety and/or efficacy endpoints while safeguarding clinical trial participants. How can data integrity be ensured? This requires a combination of a few key players during the course of a study.

In the world of clinical research, many of us have heard of Bristol-Myers Squibb (BMS), a well-known global biopharmaceutical company.  In a recent article online at Applied Clinical Trials, Thomas Verish, Group Director of Data Operations Services, discusses the risk-based monitoring (RBM) strategy that Bristol-Myers Squibb has begun using.

In a recent blog post, we provided an overview of the “Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” that the FDA released this past August.  Risk-based monitoring continues to remain a hot topic as the industry navigates its comfort level with this new approach.

IMARC Research will be participating in BioOhio’s Regulatory Forum on October 3rd from 9:00 a.m. – 5:30 p.m. BioOhio has partnered with REU Associates to discuss regulatory issues that impact Ohio’s medical products industry. 

This month, FDA officially released the new Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.  The draft guidance was originally released in August 2011, and has been a popular topic of conversation over the two year period before becoming final.  You may recall a recent blog we posted about the concept of Risk-Based Monitoring and how it seems to be met with some skepticism and confusion amongst the clinical research community.  Hopefully now, with FDA’s “current thinking” on the topic becoming official, we can all review what exactly FDA’s vision for the future of monitoring entails.

Recently, my inbox has been inundated with training opportunities for Risk-Based Monitoring.  Since the FDA’s release of its latest guidance on monitoring in August 2011, the pharmaceutical and device industries have made this a hot topic of discussion.  It seems the term, Risk-Based Monitoring, in spite of the guidance, has become an obstacle.  What is Risk-Based Monitoring?  And what is causing the confusion?  Perhaps the clearest definition for Risk-Based Monitoring was given by a presenter at the Global ACRP Conference this year in Tampa.  She referred to it as “Intelligent Monitoring”.  That says it all, doesn’t it?  Visually, I see the AT&T Commercial (It’s Not Complicated “Infinity”) with all the kids sitting around a table discussing big numbers with a grown-up.  When a little girl responds “Infinity times infinity” the grown man responds by motioning that his head just burst.

Following the release of the 2011 draft Guidance for Industry Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring, sponsors are looking for more ways to implement this approach that will mutually benefit the sites and sponsors without jeopardizing the safety of the subjects and the quality of the data. One suggestion that has been noted in the field leans toward hospitals allowing monitors access to electronic medical records (EMR) to monitor remotely.

In August 2011, FDA released a draft guidance document recommending a Risk-Based approach to monitoring. Risk- Based Monitoring combines the vigilance and data surveillance (key features of Electronic Data Capture systems) with traditional on-site data verification targeting critical data points. Rather than a standardized monitoring plan, Risk-Based Monitoring aims to adapt the monitoring plan to the changing needs of the Study, Site and Investigational Product.