Remote monitoring in the spotlight
By Maria Paluselli, MS, Project Manager and Medical Writer, DZS Clinical Services
The COVID-19 pandemic has impacted nearly every facet of daily life, including conducting clinical research trials. Quarantines, site closures, travel limitations, supply chain for investigational product and necessary equipment, and the possibility of staff or study patients becoming infected can all lead to delays in study timelines and challenges in complying with the study protocol. Measures to minimize onsite exposure such as excluding external visitors have made us nostalgic for the days of on-site study monitoring visits.
However, the COVID-19 pandemic hasn’t changed sponsor obligations to ensure the rights and safety of patients are protected, trial data is complete, accurate and verifiable, and that study activities are compliant with the protocol, Good Clinical Practice, and regulatory requirements. The FDA has issued a Guidance for the Conduct of Clinical Trials during the COVID-19 Public Health Emergency (August 2021) which includes the recommendation to optimize use of central and monitoring programs to maintain oversight of clinical sites if on-site visits are not possible.
Key factors to successfully maintaining site oversight with remote monitoring include:
• Technology: Use of systems like electronic Trial Master Files (eTMF), electronic medical records (EMR), and electronic data capture (EDC) for study data facilitate remote monitoring. Some form of video conferencing can help you go on a ‘virtual tour’ during a pre-qualification or initiation visit, meet with study staff to resolve issues, and if needed, conduct an ‘over the shoulder’ review of items not available electronically such as informed consents, or do a virtual drug accountability. A secure File Transfer Protocol (FTP) site may be needed to safely upload redacted source documents for source document verification in a controlled environment where documents cannot be downloaded. Sites may have obstacles to connectivity and access, and digital solutions may need to be either sponsor-driven or site-procured depending on site needs and restrictions.
• Planning: Conducting a visit remotely may involve extra steps at the beginning of the study, for example to obtain remote access to source documentation, whether it be institutional approval for remote read-only EMR access, or setting the procedure for redacted source documents to be uploaded to an FTP. It will also require careful planning prior to each remote monitoring visit to ensure necessary documents are available and uploaded, and to schedule the necessary time with site staff needed to accomplish monitoring activities.
• Fostering Site Relationships: Recognize that the study staff may be stretched and stressed due to staff shortages, supply shortages, and the current environment. There may be a perception that remote visits require more time and effort from the study staff. In reality, it may be that remote visits require more concentrated blocks of time from the study staff rather than small blocks spaced through the day of an onsite monitoring visit, but the same amount of dedicated staff time overall. Be clear about the activities planned during the visit and the documents and site time needed to accomplish them. Encourage your site contacts to call you with questions between visits. If the Investigator is not available during the remote visit, follow-up by phone to check-in and discuss any issues identified.
Remote monitoring is here to stay; the FDA has been encouraging centralized monitoring since 2013 in their Guidance on A Risk-Based Approach to Monitoring. The recent public health emergency has accelerated the shift to remote monitoring, and has given sites and sponsors the opportunity to see the benefits of reduced costs and increased efficiency offered by remote monitoring.