Crf Adaptations during Covid-19 - Creative Solutions to Deliver Quality Clinical Research during a Pandemic

ABSTRACT

To highlight how we continued to carry out early phase clinical trials throughout the pandemic and found innovative ways to tackle a number of operational challenges we faced in the past year. The COVID-19 pandemic presented a unique set of challenges to continuing clinical research activity and providing quality care for our research patients. In order to keep essential research going the CRF adapted to new ways of working. The CRF implemented processes to deliver IMPs throughout the national lockdown methodologies to prioritise early phase clinical trials to remain open technological adaptations to our electronic patient record system to enable video appointments the introduction of remote monitoring visits via GOSHLink for secure off site access to study documentation, ensuring our young patients still had a high quality patient experience by introducing personalised play boxes as well as maintaining staff morale and a sense of team spirit. The CRF team also needed to introduce changes. Those staff not redeployed to the clinical service introduced a change to shift patterns incorporating long days to reduce exposure and to ensure adequate cover for the essential on-site visits. All staff trained to cross-cover all prioritised trials that needed on site dosing visits. We received positive feedback from families regarding remote visits as well as the changes within the unit which ensured a safe environment for our patients Despite the challenges faced our adapted way of working has had a number of benefits and will inform our process moving forward.