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Compliance In Focus
Posted by John Lehmann on Wed, May 9, 2012

Monitoring: A Risked-Based Approach Day-to-Day

A New Monitoring ApproachOftentimes when one thinks of clinical trial monitoring, he thinks of a monitor making periodic site visits to the hospital or institution where the trial is taking place.  During these visits, the monitor verifies the data collected with the site’s source data and study documentation, among other duties.  These periodic site visits are often scheduled and made on an elapsed duration.  For example, some sponsors/studies require a monitor to be on site every 4-6 weeks to keep tabs on the data.  Seems like a pretty straightforward, streamlined, routine process, right?

Albeit this approach may be “comfortable” for some in the industry, it may not be the most cost effective or efficient for all parties involved.   Depending on the site, complexity of the study, or patient enrollment, a monitor could make several trips to the site to do source verification.  With fuel and airline costs on the gradual incline, this may become very costly for a sponsor to send a monitor to a site every month.  In addition, near-constant periodic monitoring visits can be very disruptive and time consuming to the site personnel.  With my background as Clinical Research Coordinator (CRC), I can attest that it is never great to be on the receiving end of a periodic monitoring visit where query after query is issued due to mis-spelled medications or incorrect adverse event terminology used.  One periodic monitoring visit could result in hundreds of queries that perhaps could have been issued and resolved prior to the visit.   This is not an effective or efficient use of time for a coordinator or a monitor.

So, what is an effective monitoring method? How about one that is cost effective, best utilizes time, and allows as few interruptions to a CRC, PI, and monitor as possible?

In August 2011, the FDA replaced their 1988 Monitoring Guidance with a concept that fits this approach. The draft guidance is called A Risked-Based Approach to Monitoring.  If you haven’t read it, I highly recommend it as a great tool and resource for our industry. The draft guidance mentions a cost effective tactic of monitoring remotely and making site visits less frequently- unless of course there are potential risks identified. But, what does this mean on a day-to-day base for research teams?

  • Monitors can target on-site monitoring visits by identifying high risk sites
    • Make sites visits that consider the most risk (i.e. sites that enroll many subjects in a short amount of time, many non-compliance issues etc.).
  • Monitor data quality by routine review of data (i.e. check for mis-spellings or data entry quality) and issue queries in real-time
    • On-site visits would be more efficient for monitors and CRCs.  A decrease in time spent issuing and resolving the “dreaded” query!  A win-win for both.
  • Analyze site characteristics, performance metrics, and clinical data to identify sites with features correlated with non-compliances
    • Monitors can work with the sites remotely to address non-compliances found during remote review (i.e. noting study visits are not being done within the protocol defined window).   Another win-win.   Tackling an issue before it could become a consistent problem at the site.
  • On-site monitoring visits can be more efficient as the monitor would have time to follow-up/complete administrative and regulatory tasks
    • How many of us feel “there is never enough time on site” and frantically running out the door to catch our flight or train and not being able to address issues with regulatory?  More time could be spent addressing patient safety issues (what we are all here for) and ensure proper reporting. 

Over all this method can prove to be more cost effective for all parties involved, and can be less disruptive to the sites. This approach has already been adapted by others in the industry. The Risked-Based Approach is in line with IMARC’s goals for monitoring- providing cost effective services to ensure data has integrity, sites are compliant, and patients are protected.

What are your experiences in risked-based approach monitoring? Do you think this will eventually be adapted as an industry norm? Share your thoughts and experiences with us!

Photo Credit: Oberazzi

Topics: Clinical Research, Clinical Monitoring

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