Like many other industries, clinical research has been impacted with sites needing to adapt their processes nimbly to accommodate the disruptions to “business as usual” brought on by the pandemic. Ordinarily, our site would have never considered a shift to remote monitoring, but in order to continue offering trial options to our patients and to continue to receive funding for our operations, developing this process was our only option to move forward.
It is a challenge to appease all stakeholders when developing a remote monitoring process – one has to find the right balance of accommodating differing sponsors’ needs with infrastructure capacity and maintaining operational efficiency despite the added workload. Leveraging input from your research, IT and privacy teams is an important part of developing this process – often, staff who will be executing the process are not involved in the planning stages and this can lead to challenges or failure once the process is launched. So, make sure the right input and people are involved from the start!
Sponsors are looking for a convenient, secure, and reliable method to access medical records and unredacted site data. This sensitive information must be shared securely in compliance with your site’s privacy requirements. Many sponsors will also ask for certified copies of documents, and additional documentation on system validation of your platform. Along the way we learned that many of the cloud-based platforms cannot be validated, but the majority of our sponsors have accepted this method.
Will remote monitoring continue in the future? Many of us are accommodating this as part of the extenuating circumstances of COVID-19, but if this is going to be part of the permanent landscape, additional measures such as developing appropriate SOPs or work instructions, and adding this as a line items in budgets are part of the changes to consider adopting as well.
About the author
Janice Jansen-Pereira is the Interim Director of Research at Lakeridge Health. She is responsible for oversight of research infrastructure and operations, including the clinical trials teams, fostering collaborations and advancement, and oversight of the local REB. Prior to this interim role, Janice was the Research Manager at Lakeridge Health for 4 years and brings almost 15 years of experience in Clinical Research including previous positions at St. Michael’s Applied Health Research Centre and Princess Margaret Cancer Centre.