With the release of the ‘Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring’ in August 2011, a significant amount of industry buzz continues to surround this topic. The guidance encourages sponsors to tailor monitoring plans to meet the needs of the clinical trial in an effort to potentially eliminate the current industry standard of performing 100% source data verification at all clinical sites. The growing consensus is that risk based monitoring will allow sponsors to monitor clinical trials more effectively by focusing on the most significant critical data points. Study parameters, including but not limited to protocol size, phase, complexity, clinical complexity of the study population, geography and experience of clinical investigators, will be of the utmost importance when creating the monitoring plan for the trial to adapt to the new trend.

There are many different approaches to risk based monitoring; however, to proactively ensure overall quality, significant risk assessments will need to be made at the beginning of protocol development, including the determination of the complexity of the trial and the overall experience of the clinical team. This will require significant forethought, such as the experience of clinical monitors, who may require additional training as the direct line of communication to the clinical sites. Additionally, determination of what methodology will be used during the review process will be instrumental, as this will not only be used to assess the sites’ performance but also the monitors’ performance.

The overarching questions still remain for many sponsors. How do you know when risk based monitoring is right for your trial? Will it be effective and adequate to fit the needs of your clinical program? And how do you ensure quality, integrity and safety in doing so? Will the discovery of adequacy or failure of this monitoring approach occur in real time or at the time of conducting your routine GCP audits? Will that be too late?

Posted by Amy Hansen, Director, GCP Services. For more information, please contact Amy at amy.hansen@weinberggroup.com.