9/02/2021
Photo by Amy Hirschi on Unsplash
The US Food and Drug Administration (FDA) released an updated guidance, “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”. As clinical research professionals navigate the long haul new normal, many are wondering if the remote monitoring that occurred during the pandemic shutdowns was adequate to meet regulatory requirements. The FDA continued to update the guidance as new questions arose. The new question added to the Questions and Answers section of the guidance is:
Question 28: “During the COVID-19 public health emergency some sponsors have used remote monitoring to oversee study conduct at clinical trial sites, including remote review of source data. Should data that have been remotely monitored be re-monitored during an on-site monitoring visit once pandemic-related restrictions that prevented on-site monitoring visits have been lifted?”
Summary of response: The FDA 2013 guidance on “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” clarifies that based on a risk-based assessment, sponsors can choose the method of monitoring clinical trials to meet their regulatory obligations. Continued risk assessment should be part of the monitoring plan and is needed for the sponsor’s Quality System. A decision to follow-up with onsite monitoring is linked to the risk assessment, such as a site having issues that matter (e.g., critical protocol violations). Any monitoring should focus on Critical to Quality data and processes (e.g., efficacy endpoints) and risk to human subject protections (e.g., safety assessments). Therefore, remote monitoring may remain adequate provided it is supported by the risk assessment and the monitoring plan, with both documented.
Additional clarifications may be required as the long haul normal evolves. Follow our blog to keep up to date on the latest.
-The Clinical Pathways Team
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