FDA: No Need to Re-Monitor Remote Clinical Trials
(Thursday, September 2, 2021)
Since the beginning of the pandemic, many clinical trials switched from conventional monitoring to remote monitoring for obvious reasons. Now that the pandemic related restrictions are easing, there is no need to re-monitor sites which had been remotely monitored according to the FDA. Remote monitoring or centralized monitoring has been a permitted format for monitoring the conduct of clinical investigators for the last decade. The FDA guidance on Risk-Based Monitoring published in 2013 describes FDA’s expectations from such centralized monitoring practices versus conventional on-site monitoring. Remote monitoring is facilitated by electronic case report forms and electronic medical records so long as the electronic records can be accessed remotely for review. The remote-monitoring plan should describe the processes and expectations for site record keeping, data entry, and reporting to ensure timely access to clinical trial data and supporting documentation. Criteria for risk-based on-site monitoring should be defined as well. Prior to the pandemic, studies with only remote monitoring practices were rare with most sponsors employing a hybrid model with a mix of remote and on-site monitoring. As on-site monitoring became impossible during the pandemic, sponsors were forced to revise monitoring plans to accommodate remote monitoring. The switch was not easy. It involved creating written plans and training project teams remotely, getting sites to allow remote sharing of patient medical records, and running data queries remotely. With the return to on-site travel, sponsors may be concerned about the acceptance of the quality of the remotely monitored clinical data and may consider re-monitoring on-site. FDA says, that’s not necessary. The need for re-monitoring depends on the risk-assessment by the sponsor of the monitored data. Re-monitoring may be needed only for sites with data quality issues such as suspicious data anomalies, a higher frequency of errors, unacceptable protocol violations, or higher than average dropouts. Absent these, there is no need for re-monitoring a site that has been remotely monitored so far.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC