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!