PANEL SESSION
Risk Management Emerging
Practices and the Impact of
ICH E6 (R2) Updates
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The Panelists
Duncan Hall, CEO and Founder, Triumph Research Intelligence
Johann Proeve, Chief Scientific Officer, Cyntegrity
Oleg Shevaldyshev, Associate Director, Quality Assurance, PRA Health Sciences
Renee Ekeland, Senior Quality Compliance Manager, CSL Behring
©2018 Metrics Champion Consortium All rights reserved
• How should we identify high priority risks?
• What are the challenges with risk scores?
• Which studies are suitable for a risk-based approach?
• How does outsourcing impact the risk-based approach?
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2009 2011 2014 2015 2016
A Developing Landscape…
Redefining Quality: Errors that matter & Issues that matter –
Human Subject Protection & Reliability of Trial Results
4
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5.0.1 Critical Process &
Data Identification
5.0.2 Risk Identification
5.0.3 Risk Evaluation
5.0.4 Risk Control
5.18.3 Extent & Nature of
Monitoring
ICH E6 (R2)
5.0.5 Risk Communication
5.0.6 Risk Review
5.0.7 Risk Reporting
©2018 Metrics Champion Consortium All rights reserved
5.0.1 Critical Process &
Data Identification
5.0.2 Risk Identification
5.0.3 Risk Evaluation
5.0.4 Risk Control
5.0.5 Risk Communication
5.0.6 Risk Review
5.0.7 Risk Reporting
ICH E6 (R2) – It’s Not Linear!
5.18.3 Extent & Nature of
Monitoring
©2018 Metrics Champion Consortium All rights reserved
More than Numbers and Checkboxes:
Critical Data – Critical Process – Critical Thinking
5.0.1 Critical Process &
Data Identification
5.0.2 Risk Identification
5.0.3 Risk Evaluation
5.0.4 Risk Control
5.0.5 Risk Communication 5.0.6 Risk Review
5.0.7 Risk Reporting
5.18.3 Extent & Nature of
Monitoring
ICH E6 (R2)
©2018 Metrics Champion Consortium All rights reserved
More than Numbers and Checkboxes:
Critical Data – Critical Process – Critical Thinking
5.0.1 Critical Process &
Data Identification
5.0.2 Risk Identification
5.0.3 Risk Evaluation
5.0.4 Risk Control
5.0.5 Risk Communication 5.0.6 Risk Review
5.0.7 Risk Reporting
5.18.3 Extent & Nature of
Monitoring
ICH E6 (R2)
©2018 Metrics Champion Consortium All rights reserved
Redesigned to
improve
alignment with
ICHE6(R2)
5.0 (5.0.1-5.0.7)
Quality
Management
Risk Assessment & Mitigation Management
Tool v2.0 released 9/2018
MCC Risk
Management Training
Course available
12/2018
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What is the best way to identify high priority
risks?
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AUDIENCE POLLING QUESTION #1
What do you find is the best starting point for identifying high
priority risks? (select one)
A. Risks/issues from previous trials
B. Critical data & critical processes
C. Pre-existing list of potential risks (e.g. RACT)
D. Team experience
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What is the best way to identify high priority
risks?
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What are the challenges in determining risk
scores?
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AUDIENCE POLLING QUESTION #2
Which of the following is the most significant challenge with risk
scores? (select one)
A. Uncertainty in scoring of Likelihood, Impact and/or Detection
B. Consistent scoring within a trial
C. Consistent scoring across trials
D. Determining which risks to act on after scoring
E. Lack of critical thinking
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What are the challenges in determining risk
scores?
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Which studies are suitable for RBM or RBQM?
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AUDIENCE POLLING QUESTION #3
Which studies / phases do you think are candidates for the
implementation of RBM / RBQM? (select one)
A. Phase 3 only
B. Phase 2 & 3
C. Phase 3 & 4
D. All phases 2-4
E. All phases 1-4
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Which studies are suitable for RBM or RBQM?
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How should RBM / RBQM trials be handled
when outsourced?
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AUDIENCE POLLING QUESTION #4
In an outsourced setting, who should identify and assess the
risks? (select one)
A. Sponsor company
B. CRO
C. Sponsor and CRO jointly
D. Sponsor first and then CRO adds operational risks
E. CRO first and then sponsor adds oversight risks
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How should RBM / RBQM trials be handled
when outsourced?
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Wrap-Up
• How should we identify high priority risks?
– Critical data, critical process, critical thinking
– Knowing when to stop
• What are the challenges with risk scores?
– Managing the uncertainty
– More people involved leads to more challenges with scoring
• Which studies are suitable for a risk-based approach?
– All according to ICH E6 (R2)
– Thinking beyond RBM and reduced SDV
• How does outsourcing impact the risk-based approach?
– Should have at least some joint element
©2018 Metrics Champion Consortium All rights reserved
Thank you!
Duncan Hall, CEO and Founder, Triumph Research Intelligence
Johann Proeve, Chief Scientific Officer, Cyntegrity
Oleg Shevaldyshev, Associate Director, Quality Assurance, PRA Health Sciences
Renee Ekeland, Senior Quality Compliance Manager, CSL Behring