Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals. Studies have become more complex, creating more complicated study design, which can lead to making adherence more challenging for the study team and participants. The potential risk that some aspect of the study could be done incorrectly or not comply is inherent in all studies, but particularly present in complex research. In order to help mitigate risk, advances in technology and the tools available today provide ways for us to mitigate some of the risk introduced in our clinical trials. While the study protocol is a cornerstone for the clinical trial, electronic data capture (EDC) applications have evolved in the broadest sense into technology solutions that provide us with a variety of tools to help mitigate risk.

1. LeveragingYour EDC Application to
Mitigate Risk in ClinicalTrials
March 25, 2015

2. Confidential –
Your Speaker
► 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
DurhamTechnical 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. Confidential –
Our DiscussionTopics
• Definition and Perception of ‘Risk’
• Risk-Based Quality Management
• How Can We Mitigate Our Risk Profile
– Approaches to Reducing Risk
– Review, Report, Communicate
– Leveraging Technological Tools
• Summary

4. Confidential –
Every Clinical Trial Has Inherent Risk and
Every Risk Has aTolerance Limit
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5. Confidential –
Risk
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Risk is an uncertain event
or condition that, if it
occurs, has an effect on at
least one objective.

6. Confidential –
Mitigating Risk
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Taking steps to reduce adverse effects.

7. Confidential –
Tolerance
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There is no way a sponsor
can eliminate all risks of
doing clinical trials so
defining the amount and
identifying the type of risk
that a sponsor is willing to
accept helps them evaluate
where resources should
allocated to minimize the
most significant risks.

8. Confidential –
Perception of Risk
Role and Responsibilities
– Sponsor
– Investigator
– IRB/Ethics Committee Member
– Quality Representative
– Regulator

9. Confidential –
Risk-Based Quality Management
• Start with Quality – End with Quality
– A systematic process to identify, assess, control,
communicate, and review risks associated with the trial
throughout the life of the trial

10. Confidential –
One
Approach To
Risk
Mitigation
Identify &
Assess
Control
Review &
Communicate
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11. Confidential –
Identify and Assess Risk
• Privacy Protection of Study Participants
• Patient/Subject Safety
• Quality/Reliability of Study Data

12. Confidential –
Controlling Risk
• What decisions can be made to reduce and/or
accept risk?
• Where can we mitigate risk?
• How can we accomplish this?

13. Confidential –
Review and Communication
• Document your process
• Communicate the process
• Review results
• Incorporate new information
• Update and revise your plan as needed

14. Confidential –
Develop and Implement A Plan
• Building on the answers
– Develop a plan
– Implement action for high risk
– Understand there may be implications with low risk

15. Confidential –

16. Confidential –
How Do We Do This?
• Separate prioritization from risk mitigation
• Address each stage of the trial
• Stratify/Customize the plan

17. Confidential –
Setting Boundaries – Early and Often
• Trial Data
• Monitor Protocol Compliance/Deviations
• Establish Qualification Standards/Specifications
• Define Metrics to Allow Oversight
– Data Collection, Retrieval, and Reporting
– RBM
– Quality Measures

18. Confidential –
A Sample Template
Header Categories
Risk Area/Category
Potential Risk Assessed
Risk Examples/List study specific issues
Include in Monitoring Plan (Yes/No)
ToleranceThreshold
Mitigation Strategies/Tools to be Used
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19. Confidential –
Sample Template Header
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Risk Assessment
Worksheet
Risk Area/Category Potential Risk Assessed
Risk Examples (list study specific
issues)
Include in
Monitoring Plan
(Yes/No) Tolerance Threshhold
Mitigation Strategy/Tools to be
Used

20. Confidential – 20
Study Conduct
Quality Management System-Sponsor
Level
Is there a sponsor level QMS in place,
at the CRO/support company level, at
the site level?
Required Regulatory Reporting
Does the sponsor have the
infrastructure to support the required
regulatory reporting needed? Does the
supporting organization have the
infrastructure? Does the site have a
QMS or the essential quality controls in
place?
Specific Study Activities
Informed consent process, enforcement
of INC/EXC, handling protocol
deviations/violations, stopping rules,
SAE handling, dose modifications, etc.
Investigational Product
Is there investigational product in place
to conduct the study, is there a re-
supply process, is the supply chain
establsied, are there regulatory risks for
international studies/transport/storage
of the investigational product?
Safety Concerns
Study participant protection and well-
being processes/procedures in place,
safety monitoring, know adverse
evetns/reactions, process for
documetnation and reporting of
unexpected events and SAE's
Study specific tasks
Endpoints, complexity of the study,
stage of the study, number of potential
study participants and geographic
availability

21. Confidential –
Leverage Technological Tools – Focus on EDC
► CTMS Applications
► EDC Application
• Platform – Trial-by-Trial Reporting Tools
• Platform – Cross Study Managers/Filters/Reporting Tools
• Performance/QualityTools
► Safety Application
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22. Confidential –
Reporting Quality – Leverage Technology
Critical inToday’s Trials
• Trial Data
• Monitor Protocol Compliance/Deviations
• Establish Qualification Standards/Specifications
• Define Metrics to Allow Oversight
– RBM
• Frequency
• SDV
– Data Collection, Retrieval, and Reporting
– Performance/Quality Measures

23. Confidential –
Summary
• Risk based approach starts in planning the program
not the study
• Know, Understand, and Use AvailableTools
• Adapt protocol-by-protocol throughout the program
– Learn as you go
– Adapt as you go
– Improve as you go
• Communicate, communicate, communicate
– Allow for sponsor and regulatory interactions

24. Confidential –
Questions
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25. Confidential –
Contact Information
► 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 onTwitter
• https://www.linkedin.com/company/datatrak-international
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with DATATRAK ONE
DATATRAK International
Chicago, Illinois
Cleveland, Ohio
Bryan,Texas
Cary, North Carolina
United Kingdom
888.677.DATA (3282) Toll Free
www.datatrak.com
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