2009 Web Seminar Series
Resolutions for
Unexpected
Site Challenges
An Introduction to Risk Management
Instructors: Charlotte Royer-Malvestuto, M.Ed., MBE
Jack Chally, M.B.A.
"This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse,
National Institutes of Health, Department of Health and Human Services, Under Contract No.HHSN271200522081C."
Training
Outline

Introduce Risk Management
 Risk
management recognizes and addresses
unexpected site challenges in a proactive manner
 Potential threats are embraced and addressed
instead of ignored or hidden

Case Study and Group Discussion
 Process
helps identify critical components for
continual, successful operations and the likelihood
of disruption and appropriate plan to mitigate
undesirable events
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http://www.darwinawards.com/
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Risk
Management

Risk
A
probability that some adverse circumstance will
occur

Risk Management
 Process
for risk identification and contingency plan
development to address risks



Done with each study section or overall
Assess probability of occurrence (80%)
Strategy or contingency plan for each risk
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Risk
Management
Process

Risk Management Process

Risk identification


Risk Assessment/Analysis


Assess likelihood and
consequences
Risk Planning


Identify project, product
and risks level
Develop plans to avoid or
minimise risk impact
Risk Monitoring/Controlling

Monitor and adjust plans
Risk Identification
• Brainstorm to identify
potential problems
Risk Assessment
•
•
•
•
Assess risk
Severity
Likelihood
Controllability
Risk Response Development
• Plan to reduce possible damage
• Make contingency plans
Risk Monitor/Control
• Implement risk strategy
• Monitor and adjust
• Change management
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Revealing & Planning
for Vulnerable Operations


Generate list of possible risks
Goal = Find potential problems before they happen




Break into task areas
Brainstorm
Past experience
Focus on events that could create unwanted outcome
Events
Shipping delays
Outcomes
Failure to meet schedule
Toy on stairs
Staff member breaks leg
Snow storm
Opened late
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Revealing & Planning
for Vulnerable Operations
Risk Log
Risk Event
Outcome
Impact
Likelihood
Staff turnover
CTP Buy-in
Miscommunication
Informed Consent Errors
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Minor
Risk
2
3
Moderate
Risk
4
5
Major
Risk
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Risk
Assessment
Process
Risk Log
Driving to Work in the Rain
Risk Event
Stuck in traffic
Outcome
Impact
Likelihood
Missed client
meeting
4
4
1
Minor
Risk
2
3
Moderate
Risk
4
5
Major
Risk
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Risk
Assessment
Process
Risk Severity Matrix
Driving to Work in the Rain
Likelihood
5
4
3
2
1
1
2
3
Impact
4
5
Minor
Risk
Moderate
Risk
Major
Risk
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Risk
Assessment
Process
Risk Response Matrix
Driving to Work in the Rain
Risk Event
Stuck in
traffic
Response to
Risk
Reduce, Share,
Transfer or Accept
risk
Contingency
Plan
Leave 30 minutes
early
Trigger
Weather
report
Person
Responsible
Jack
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Risk Assessment &
Management
CASE STUDY
Jane, a new RA, is conducting all scheduled study visits but is often unable to
complete and enter the CRFs within the required timeframe.
It is becoming increasingly difficult to remember visit specifics and she is
concerned about the quality of the data.
Risk Log
Risk Event
Lag in CRF
Completion
Outcome
Missed
data/increased
data queries
Impact
Likelihood
4
4
1
Minor
Risk
2
3
Moderate
Risk
4
5
Major
Risk
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Risk Assessment &
Management
Case Study
Risk Severity Matrix
Likelihood
5
4
3
2
1
1
2
3
Impact
4
5
Minor
Risk
Moderate
Risk
Major
Risk
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Risk Assessment &
Management
Case Study
Risk Response Matrix
Risk Event
Response to
Risk
Lag in CRF
Completion
Reduce, Share,
Transfer or Accept
risk
Contingency
Plan
Training Time
Management
/Cross-train
Trigger
QA
visit/Data
Queries
Person
Responsible
Project Manager
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Group
Discussion
Risk Assessment
and
Management
Process
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Group
Discussion
Risk Log
Risk Event
Outcome
Impact
1
Minor
Risk
Likelihood
2
3
Moderate
Risk
4
5
Major
Risk
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Group
Discussion
Risk Severity Matrix
Likelihood
5
4
3
2
1
1
2
3
Impact
4
5
Minor
Risk
Moderate
Risk
Major
Risk
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Group
Discussion
Risk Response Matrix
Risk Event
Response to
Risk
Contingency Trigger
Person
Plan
Responsible
Reduce, Share,
Transfer or Accept
risk
Reduce, Share,
Transfer or Accept
risk
Reduce, Share,
Transfer or Accept
risk
Reduce, Share,
Transfer or Accept
risk
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Summary

Risk Assessment Process
 Reveals
critical tasks in operations
 Possibilities for disruption

Likelihood and impact rating
 Appropriate

response strategy
Tools
 Risk
event log
 Risk Severity Matrix
 Risk Response Matrix
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