Tenders Are Invited For 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 Study Closure The Files Are Sent To An Off-Site Storage Facility For Periods Ranging From Five To 25 Years Depending On The Nature Of The Study.≪Br/≫≪Br/≫The Directorate Wishes To Implement A Fully Electronic Site File For Each Study That Will Vastly Reduce The Use Of Paper Documents, Reduce The Amount Of Staff Time Spent On Printing And Filing And Eliminate The Requirement To Use An Off-Site Storage Facility To Archive The Documents Of Studies That Have Closed.≪Br/≫The System Must Have The Facility To:≪Br/≫≪Br/≫A.Store And Version-Control Documents≪Br/≫B.Allow Electronic Signature Of Documents≪Br/≫C.Be Accessed And Viewed Remotely By Non-Trust Employees With Appropriate Access Controls≪Br/≫D.Be Aligned With Good Clinical Practice (Gcp) Expectations Around Controls, Security, Training And Validation (Section 10.5.3 In The Grey Guide)≪Br/≫E.Comply With Medicines & Healthcare Products Regulatory Agency (Mrha) Regulatory Requirements≪Br/≫F.Create An Audit Trail For All Activities In The System.≪Br/≫G.Create A Comprehensive Folder Structure With Sub-Folders To Facilitate Storage And Easy Retrieval Of Documents≪Br/≫H.Be Configurable To Organisational Requirements≪Br/≫J.Have Search Functionality For The Location Of Documents With Multiple Options Including Pdf ≪Br/≫J.Exchange Regulatory And Source Documentation With Sponsor/Ctu≪Br/≫K.Manage Study Timelines Via Alerts E.G. Submission Of Annual Reports≪Br/≫L.Manage “Live Documents” E.G. Amendment Logs, Delegation Logs, Ae/Sae Logs