The clinical monitor, nowadays also called Clinical Research Associate or CRA, is an important function mentioned in Good Clinical Practice guidelines, primarily ICH E6 and DIN EN ISO 14155. For me personally, it still is of utmost importance that the monitor serves as the main line of communication between the sponsor and the investigator. While sometimes the monitor’s work is reduced to executing quality checks, the real value of clinical monitoring in a study is definitely broader and the challenges for a CRA are complex. Keeping this in mind, you as a sponsor should consider the following:
Key Considerations for Sponsors
Based on my last blog Planning the Clinical Monitoring Approach, the complexity of the monitoring strategy will be based on and related to risk assessment aspects. Furthermore, the operational details and complexity of the study protocol and its stipulations will affect your monitoring strategy.
Involve monitors early into operational considerations.
The clinical monitor is an important member of your study team and should be involved by Project Management in the operational planning at an early stage. E.g., monitors know very well whether site personnel will cope with the digital systems and procedures that you plan to implement.
Have experienced monitors qualify the investigational sites.
The qualification of a potential investigational site is one of the most critical steps in the process. Skilled and experienced monitors will be your best choice in selecting suitable investigator teams. In addition to checking formal and GCP-relevant requirements, the monitor will be able to understand and assess whether the site is fit for your clinical study.
Establish a good communication plan considering the interfaces monitor-sponsor and monitor-site.
Again, planning is key. Make use of the monitors being the main line of communication between investigators and you as a sponsor. Train your monitors on the study-specific communication lines and contact partners, oversee the process, and implement regular lesson-learned meetings for successful study conduct.
Thank you for taking the time to read about optimizing the clinical monitoring approach. If you haven’t yet explored our insights on planning the clinical monitoring approach, filled with valuable advice, we invite you to read it here.
Clinical monitoring is key in quality control for clinical trials. Our experienced monitors ensure patient rights, data integrity, and regulatory compliance. We offer on-site and remote monitoring for all sizes of studies. Our CRAs see and serve the needs of both the sponsor and the trial team, ensuring the quality of your clinical trial. Learn more about our services here.
Autor: Dr. Christoph Ortland, December 2023
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