What does "remote monitoring" in clinical trials refer to?

Remote monitoring in clinical trials refers to a strategy to oversee trial activities using technology. This approach utilizes various digital tools and systems to collect, manage, and review data without requiring direct, in-person oversight at the trial sites. It enables clinical research organizations to monitor patient progress, ensure compliance with the trial protocol, and evaluate data quality in real-time, thereby improving overall efficiency and reducing the need for frequent site visits.

The ability to utilize technology for monitoring is particularly important in today's clinical research environment, where geographic diversity of study sites and participant convenience are essential for enhancing enrollment and retention. By employing remote monitoring, trial sponsors can maintain oversight of various trial activities, including participant safety, data integrity, and adherence to Good Clinical Practices.

Other options do not align with the concept of remote monitoring. Conducting in-person visits does not leverage technology for distance oversight. Reviewing data only at trial completion suggests a more traditional approach that misses the real-time benefits of remote monitoring. Auditing trial sites annually focuses on compliance checks that are too infrequent and does not utilize technology effectively for ongoing monitoring.