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/>Many of the above documents are dynamic and version-controlled and paper copies of all changes must be retained for audit purposes. After stu…