Resolutions for Unexpected Site Challenges

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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."
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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 Identification
• Brainstorm to identify potential problems

• Risk Management Process
• Risk identification
• Identify project, product and risks level
• Risk Assessment/Analysis
• Assess likelihood and consequences
• Risk Planning
• Develop plans to avoid or minimise risk impact
• Risk Monitoring/Controlling
• Monitor and adjust plans

• 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

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Revealing Planning for Vulnerable Operations
Risk Log
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Risk Assessment Process
Risk LogDriving to Work in the Rain
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Risk Assessment Process
Risk Severity Matrix Driving to Work in the Rain
Likelihood
Impact
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Risk Assessment Process
Risk Response MatrixDriving to Work in the Rain
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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
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Risk Assessment Management Case Study
Risk Severity Matrix
Likelihood
Impact
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Risk Assessment Management Case Study
Risk Response Matrix
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Group Discussion

• Risk Assessmentand Management Process

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GroupDiscussion
Risk Log
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GroupDiscussion
Risk Severity Matrix
Likelihood
Impact
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GroupDiscussion
Risk Response Matrix
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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