The dabl ABPM system and ABPM device logistics service obviates hospital trial site visits during this COVID-19 pandemic resulting in uninterrupted workflow.
The FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic – updated April 2, 2020 – allows for changes to be made to the investigational plan or protocol without prior FDA review or approval, if the change is intended to eliminate an apparent immediate hazard or to protect the life and well-being of subjects. Therefore, changes in protocol conduct necessary to immediately assure patient safety, such as conducting telephone or video contact visits for safety monitoring rather than on-site visits, can be immediately implemented with subsequent review by the
IRB and notification to FDA.
Throughout the pandemic, dabl ABPM systems and ABPM device logistics service have continued to deliver results while ensuring patient safety and relief of pressure on clinicians and hospitals. The trial site investigators may work from home and, as per FDA guidelines, arrange for virtual visits via video conferencing or telephone calls and the delivery and collection next day of 24-hour ABPM devices to and from subjects’ homes via courier services. The investigators can then upload the recorded BP data via the dabl system. During this process the integrity of the trial remains solid, at no point is any trial subject’s anonymity compromised and all data remains blinded as per study protocol requirements.