View this recorded webinar to hear an overview of the Guidance Document on Electronic Source Data in Clinical Investigations and its practical implementation.

1. August 20, 2014
eSource: What You Need to
Know

2. Your Speakers
► Maura Bearden
• Maura is a graduate of the University of North Carolina at
Chapel Hill and has been with DATATRAK in a variety of
Clinical Data Management roles since 2012. Ms.
Bearden’s expertise is in the streamlining of study start-up
tactics, data management and customer service.
► Bill Gluck, Ph.D.
• Dr. Gluck has over 30 years of expertise in clinical
research, with experience in sponsors, CROs, and with
DATATRAK in a variety of roles. Dr. Gluck is also the
Program Director for the Clinical Trials Research and
Medical Product Safety/Pharmacoviligance programs at
Durham Technical Community College. Dr. Gluck earned
his Bachelor of Science Degree at the University of
Scranton and Master and Ph.D. degrees from North
Dakota State University.
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3. Agenda
► Key Dates in Time: eSource
► Overview of the Guidance Document on
Electronic Source Data in Clinical Investigations
► Why eSource?
► Practical Applications – eSource: A CDM’s Tale
of Three Studies
• Challenges of eSource Studies
• Benefits of eSource Studies
• Future of eSource
► Summary
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4. Dr. Bill Gluck
Vice President Clinical Knowledge
DATATRAK International
eSource: Guidance Overview

5. Genesis of eSource: Key Dates in
Time
► 1968 – LL Weed, New England Journal of
Medicine 278:593-600
► 1980’s-present – Evolution of IRT, EDC,
ePRO/eCOA technologies
► 1997 – Regulatory definitions begin to evolve
• CDISC and an industry-led standardization movement
begin
► September 2013 – Guidance for Industry on
Electronic Source Data in Clinical Investigations
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6. Guidance Document Addresses the
Following
► Identification and specification of authorized
source data originators
► Creation of data element identifiers to facilitate
examination of the audit trail by sponsors, FDA,
and other authorized parties
► Ways to capture source data into the eCRF
using either manual or electronic methods
► Clinical investigator(s) responsibilities with
respect to reviewing and retaining electronic
data
► Use and description of computerized systems in
clinical investigations
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7. eSource studies pertain to clinical trials where
direct data entry into an electronic data capture
system (EDC) is used in contrast to paper
source studies where data are transcribed from
a paper source into EDC.
Simply put (from the Guidance Document):
“Electronic source data are data initially recorded
in electronic format.”
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8. Data Capture: Electronic Source Data
Origination
► List of authorized source data originators should be
developed and maintained by the sponsor and
made available at each clinical site
► Examples of Data Originators:
• Clinical investigator(s) and delegated staff
• Clinical investigation subjects or their legally authorized
representatives
• Consulting services
• Medical devices
• Electronic Health Records
• Automated laboratory reporting systems
• Other technology
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9. Data Capture: Source Data Capture, Data
Element Identifiers, Modifications and
Corrections, and Use of Data Quality Checks
► Source Data Capture
• Direct entry of data into the eCRF
• Automatic transmission of data directly into the eCRF
• Transcription of data from paper or electronic sources
to the eCRF
• Direct transmission of data from the EHR to the eCRF
• Transmission of data from PRO instruments to the
eCRF
► Data Element Identifiers
► Modifications and Corrections
► Use of electronic prompts, flags, data quality
checks in the eCRF
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10. Data Review
► Clinical Investigators
• Clinical Investigator(s) review and electronic signature
• Data exempt from investigator(s) review
► Modifications and Corrections During Review of
the eCRF
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11. Retention of Records by Clinical
Investigator(s)
► Retain control of the records
• Completed and signed eCRF
• Certified copy of the eCRF
► Be able to provide inspectors with access to the
records that serve as electronic source data
► When transcription from paper occurs – the
paper is the source and must be retained
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12. Data Access
► Viewing Data
• Sponsors, CROs DSMBs and other authorized
personal can view data before and after the clinical
investigator has signed the completed eCRF
– Allow for early detection of study-related problems
– Missing data
– Data Discrepancies
► CDMP should list individuals with authorized
access to the eCRF
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13. Use and Description of Computerized
Systems
► Adequate controls must be in place
► Note: determination of whether a computer
system is suitable may not be under the control
of the clinical investigator or sponsor (EHRs for
example) – see 45 CRF Part 170
► Documentation – if computerized system are to
be used
• Protocol/CDMP/Investigational plan
• Description of security measures employed to protect
the data
• Description/Diagram of the electronic data flow
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14. Why eSource?
► Companies are reluctant to move away from
paper-based source documentation
• It is very familiar and is today’s standard
• It is well documented and has a clear audit trail
• It has well documented security measures
► eSource
• Higher data integrity = Streamlined Data Review
Process
• Real-time accessibility
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15. Maura Bearden
Clinical Data Manager
DATATRAK International
Practical Applications
eSource: A CDM’s Tale of Three
Studies

16. eSource Case Studies
► Three Different eSource Studies
► Study 1:
• Phase 2, 160 subjects and 24 sites
► Study 2:
• Phase 3, 400 subjects and 31 sites
► Study 3:
• Phase 2, 210 subjects and 20 sites
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17. eSource Case Studies
► Analysis of three studies provides the
following information:
• Challenges of eSource Studies
• Benefits of eSource Studies
• Future of eSource
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18. Challenges of eSource Studies
► Workflow process between monitoring and
data management
► Protocol-Specific system checks
► FDA Guidelines pertaining to data
originator elements for transcribed
assessments
► Site Compliance of FDA Guidance of
electronic source data
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19. Challenge of Workflow Process
► Workflow process between
monitoring and data management
• Study: Cross-comparison of all three
studies
• Problem: How to document the review
between monitors and data
management
► Solution: Additional data review flag
19

20. Challenges of Protocol-Specific
Checks
► Protocol-Specific System Checks
• Study: Progression of all three studies
• Problem: Number of protocol-specific system
checks
► Solution: Identification of integral protocol
checks, help prompts and additional
electronic case report forms (eCRFs)
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21. Challenges of FDA Guidelines
► FDA Guidelines pertaining to data
originator elements for transcribed
assessments
• Study: Study 3
• Problem: Coordinator entering information
into eCRF that is being read off by PI and the
conflict with the data originator in EDC.
► Solution: additional review fields on eCRF
that correspond to authorized data
originator
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22. Challenges of FDA Guidance
► Site Compliance of FDA Guidance of
electronic source data
• Study: Study 1
• Problem: Sites writing study information on
paper
► Solution: Note-to-File regarding paper
sources and retraining of site
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23. Benefits of eSource Studies
► Higher Data Integrity
► Real-Time Data Availability
► Decreased Time for Data Management
Review
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24. Higher Data Integrity Benefit
► Higher Data Integrity
• No queries needed to correct transcription
errors between paper source and EDC
• Protocol-specific edit checks in the system
and eCRF prompts prevent subjects who are
not qualified from being randomized in the
study
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25. Real-Time Data Availability Benefit
► Real-Time Data Availability
• Allows for all information to be available at
any time
• Reduce review time querying site to enter
information
• Allows for real-time reports with all available
data
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26. Decreased Time for Data Mngt
Review
► Decreased Time for Data Management
Review
• Reduced number of confirmation queries
• Limits data management review to cross-
checks and traditional data management
reviews
• Remote monitoring (increased importance)
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27. The Future of eSource
► Familiarity and optimization of start-up and
workflow process of eSource studies
• Familiarity and optimization can be seen in an
analysis of study 2 and study 3.
–Decreased study deployment time
–Distinct data review responsibilities for data
managers and monitors
–Streamlining user errors
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28. Conclusions
► eSource has been recognized as an accepted
means of capturing clinical data during clinical
investigations by the FDA
► The FDA has provided guidance to industry for
its implementation and use
► Case studies demonstrate the benefits of
eSource trials:
• Higher data integrity
• Real-Time accessibility
• Streamlined Data Management Review Time
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29. Questions
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30. Contact Information
► Maura Bearden
• Maura.Bearden@DATATRAK.com
► Bill Gluck, Ph.D.
• Bill.Gluck@DATATRAK.com
► General Questions about DATATRAK
• Dorothy.Radke@DATATRAK.com
► Find Us Online
• www.DATATRAK.com
• http://www.slideshare.net/DATATRAK
• @DATATRAKinc on Twitter
• https://www.linkedin.com/company/datatrak-
international
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31. from Concept to Cure
with DATATRAK ONE
DATATRAK International
Cleveland, Ohio
Bryan, Texas
Cary, North Carolina
London, UK
888.677.DATA (3282) Toll Free
www.datatrak.com
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