Contract for a Digital Site File Application

The Clinical Research Directorate of the Newcastle upon Tyne NHS Foundation Trust currently maintains a large number of paper site files relating to study governance. Each site file contains documents such as study protocols, ethics regulatory approvals, delegation logs, training logs, consent forms and email correspondence. Each study will have between three and ten large lever arch site files and there are currently 1,400 studies in progress.<br/><br/>The Trust is to implement a fully electronic site file for each new study going forward and brings with it numerous benefits.