eSource: Unlocking the Efficiencies of Electronic Source Data Capture Ed Seguine, CEO, Clinical Ink April 15, 2014 Faculty Disclosure In compliance with ANCC Guidelines, I hereby declare: I do not have financial or other relationships with the manufacturer(s) of any commercial service(s) discussed in this educational activity. Ed Seguine CEO, Clinical Ink 2 Learning Objectives • • • • Understand current responsibility of sites for source data Differentiate the various forms of clinical data capture Distinguish the benefits of eSource for data capture Suggest site involvement with eClinical Forum eSRA tool FDA 2014: Promoting eSource No Paper: Direct Entry into eCRF Source: 2014 FDA “Promoting eSource Data Capture” Source Data: Site Responsibility Source data must be: Attributable Legible Contemporaneous Original Accurate Inadequate case history is 2nd most common site audit finding Clinical Research Today Day 0 Day 5-14+ Paper Process = Complexity, Errors, Cost Day 30-60+ Clinical Research Tomorrow Real-Time Data Availability: No Paper, No Errors, No Travel eSource vs Paper eSource Paper Original Record Secondary Copy Comprehensive Content Limited Dataset Clinical Focus (Workflow, Unstructured) Data Focus (Standardized) Investigator Control Sponsor Control REVIEWED for context, safety, trends, compliance VERIFIED for accuracy, validity, errors Sites choose how to capture Source Paper: Worst Case Scenario EDC: Rarely Used as eSource Inconsistent with site workflow Inability to work offline Restrictive Data Entry eSource: Best Case Scenario Tablet Portal Server Workflow Comparison Create Create eSource Source Today Create CRFs Create CRFs Capture Patient Source Data Capture Patient Source Data Enter Patient Data in CRF Enter Patient Data in CRF Onsite Validation Remote Monitoring SDV & Query CRF Review Source Review Source Onsite Validation SDV & Query CRF Review Source Site Activity Sponsor Activity Xfer to Data Management Clinical Ink Activity Xfer to Data Management Tomorrow Create Source Electronic Source Records Application: Portal Dashboard Copy, Export, Print Sortable Headers Search Clickable Links Application: Document View Interactive Document View Click field to add query Query List Form History Validations Benefits of eSource Source Data Verification Data Queries (60-70%) CRA Visits Fraudulent, Erroneous Data Remote Monitoring of Source Documents Site Interactions Site Productivity, Satisfaction Speed R&D Timelines, Dramatically Reduce Costs Case Study: Novartis 55 MINUTES Site Assessment to DV Visualization MONITORING TIME: -38% Source Data Reconciliation vs. Source Data Verification eSRA: eSource Readiness Assessment We need assessment tool that can evolve, adapt for future needs eClinical Forum: eSRA Tool ASSESSMENT QUESTION Site responsibilities for meeting these requirements Example for Site Vendor Response Does your site (system + processes) meet this requirement? AUDIT TRAIL 1) Does the system show the creation, alteration, or deletion of data/electronic health information with date, time, the patient identification, and the identification on the person who entered data? 4 20 Copyright eClinical Forum 2014 Site must ensure that audit trail (audit log)functionality has been installed and is working correctly. [Workaround: If an audit trail is not available additional process controls such as a signed and dated print out, will have to be introduced to maintain the information] Y - to be confirmed by Site IT Y N W 2014: eSRA Implementation Investigator Site eSource-Readiness Assessment Tool (eSRA) Thank You!