COVID-19
for reporting adverse events, for example. Home visits have also been discussed for many years for national centres. This would have been a great solution for many studies, both enabling continuous oversight of patient’s safety, but also reducing risk for patients by not having to travel to the larger populated areas where Covid-19 cases were more common. Working with oncology studies, however, it might be more difficult due to the need for tumour assessment and correspondingly access of CTs and MRIs.
Proper implementation of risk assessment and taking action when it counts As
– a term that I have heard presented by contract research organisations for about ten years. However, when the situation of Covid-19 began, the processes were unclear and not ready to be implemented promptly. I would advocate a proactive set-up of remote versus on-site monitoring and also to assess the impact on other parties. Hospitals are often not allowed to send patient information outside the hospital and perform source data verification over the phone – this adds a high burden on site staff and with limited staff at site due to the pandemic, this is very difficult to resolve.
“Whether it is related to proactive actions mitigating a known risk, corrective actions to limit risk occurring or taking actions promptly when a risk turns into an issue, acting with a sense of urgency is of utter importance. ”
How can we resolve this moving forward? Access
to electronic patient journals should technically be possible to provide to external parties outside of hospitals. If complying with regulations related to access control (for example, 21 CFR Part 11), monitors should be able to perform this task outside the walls of the hospital. This, of course, is a political debate as well as a question about functionality of the system. It is also important to ensure compliance with GDPR. Another aspect for discussion is the possibility for the patient to have a phone call with hospital
82 | Outsourcing in Clinical Trials Handbook
briefly touched upon previously, risk assessment should not be about personality traits of a leader, nor about a one-time paper exercise in getting the risk log finalised for the first subject. The only way to ensure that this works for the entire team is to implement it properly across cross-functional plans, project management plans, communication/escalation plans (including appropriate escalation process of risk becoming an issue), monitoring plans (for example, remote monitoring, criteria and process), and data management plans. Some contract research organisations work actively with a solid template that list all the common risks seen in clinical trials. In these cases, the risk log becomes very long and leads to the need for a proper assessment of the risk score and prioritising adequately. Although I favour a solid template, it seems that this reduces proper discussions taking place – risk discussion meetings fail to be set-up and the risk log is not adapted to the specific study – cross-functional study-specific discussions are also crucial, even if templates are developed. Whether it is related to proactive actions mitigating a known risk, corrective actions to limit risks occurring or taking actions promptly when a risk turns into an issue, acting with a sense of urgency is of utter importance. To do this, it is key to understand the importance of your own role in the project and have a good knowledge of what other team members do, in order to quickly communicate to those affected. Teams that take the responsibility of dealing with an issue will be the most successful and, to do this, the entire team – not to mention the project management – needs to understand what is of the highest priority from a patient safety, financial and regulatory point of view at all times. ●
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