eSource: Unlocking the Efficiencies of Electronic Source Data Capture Ed Seguine, CEO, Clinical Ink April 15, 2014

2 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

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 2 nd most common site audit finding

Clinical Research Today Paper Process = Complexity, Errors, Cost Day 0Day Day

Clinical Research Tomorrow Real-Time Data Availability: No Paper, No Errors, No Travel

eSource vs Paper eSourcePaper Original RecordSecondary Copy Comprehensive ContentLimited Dataset Clinical Focus (Workflow, Unstructured) Data Focus (Standardized) Investigator ControlSponsor 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 Restrictive Data Entry Inability to work offline

eSource: Best Case Scenario Tablet Portal Server

Create eSource Create Source Remote Monitoring Review Source Workflow Comparison Create CRFs Capture Patient Source Data Onsite Validation SDV & Query CRF Review Source Enter Patient Data in CRF Xfer to Data Management Create Source Create CRFs Onsite Validation SDV & Query CRF Review Source Capture Patient Source Data Enter Patient Data in CRF Xfer to Data Management Site Activity Sponsor Activity Today Tomorrow Clinical Ink Activity Create Source Create CRFs Capture Patient Source Data

Electronic Source Records

Application: Portal Dashboard Clickable Links Search Sortable Headers Copy, Export, Print

Query List Form History Validations Interactive Document View Click field to add query Application: Document View

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

AUDIT TRAIL eClinical Forum: eSRA Tool 20 Copyright eClinical Forum 2014 Example for Site

2014: eSRA Implementation Investigator Site eSource-Readiness Assessment Tool (eSRA)

Thank You!