Clinical trials incorporate a number of processes to ensure high-quality data collection. During one key process known as Source Document Verification (SDV), clinical trial monitors check source documents from a trial site against the data collected in Electronic Data Capture Systems to ensure accuracy.
Typically, SDV takes place at the trial site in order to protect patient privacy and limit the opportunity for sensitive Patient Health Information (PHI) to be viewed outside the trial. However, with the onset of COVID-19, the ability of trial monitors to visit trial sites was greatly restricted, which meant a new SDV approach was needed.
That's why Unqork created its integrated Secure Document Exchange and Verification solution, which allows clinical research organizations and clinical trial sponsors to conduct SDV remotely, while maintaining patient privacy.
The solution includes strict role-based access control, so documents can be securely reviewed by the relevant trial monitor (and only the relevant trial monitor) before they are purged from the system.
Watch the above demonstration of the solution to see Unqork's SDV process in action from document requests to document submission to document review.