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. - PowerPoint PPT PresentationTRANSCRIPT
2009 Web Seminar Series2009 Web Seminar Series
Resolutions for Unexpected
Site Challenges
Resolutions for Unexpected
Site Challenges
Instructors: Charlotte Royer-Malvestuto, M.Ed., MBEJack Chally, M.B.A.
An Introduction to Risk Management
"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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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
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 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 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 OutcomesShipping delays Failure to meet schedule
Toy on stairs Staff member breaks leg
Snow storm Opened late
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Risk Event Outcome Impact Likelihood
Staff turnover
CTP Buy-in
Miscommunication
Informed Consent Errors
Risk Log
Revealing & Planning for Vulnerable Operations
1 2 3 4 5
Minor Risk
Moderate Risk
Major Risk
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Risk Event Outcome Impact Likelihood
Stuck in traffic Missed client meeting
4 4
Risk LogDriving to Work in the Rain
Risk Assessment
Process
1 2 3 4 5
Minor
Risk
Moderate Risk
Major
Risk
9
Risk Assessment
Process
5
4
3
2
1
1 2 3 4 5
Lik
elih
oo
d
Impact Minor
Risk
Moderate Risk
Major Risk
Risk Severity Matrix Driving to Work in the Rain
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Risk Assessment
Process
Risk Event Response to Risk
Contingency Plan
Trigger
Person Responsib
le
Stuck in traffic
Reduce, Share, Transfer or Accept risk
Leave 30 minutes early
Weather report
Jack
Risk Response MatrixDriving to Work in the Rain
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Risk Event Outcome Impact Likelihood
Lag in CRF Completion
Missed data/increased data queries
4 4
Risk Log
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.
1 2 3 4 5
Minor
Risk
Moderate Risk
Major
Risk
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Risk Assessment & Management
Case Study
5
4
3
2
1
1 2 3 4 5
Lik
elih
oo
d
Impact Minor
Risk
Moderate Risk
Major Risk
Risk Severity Matrix
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Risk Assessment & Management
Case Study
Risk Event Response to Risk
Contingency Plan
Trigger
Person Responsib
le
Lag in CRF Completion
Reduce, Share, Transfer or Accept risk
Training Time Management /Cross-train
QA visit/Data Queries
Project Manager
Risk Response Matrix
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Group Discussion
Risk Assessmentand
Management Process
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Risk Event Outcome Impact Likelihood
Risk Log
GroupDiscussion
1 2 3 4 5
Minor
Risk
Moderate Risk
Major
Risk
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GroupDiscussion
5
4
3
2
1
1 2 3 4 5
Lik
elih
oo
d
ImpactMinor
Risk
Moderate Risk
Major Risk
Risk Severity Matrix
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GroupDiscussion
Risk Event Response to Risk
Contingency Plan
Trigger
Person Responsib
leReduce, Share, Transfer or Accept risk
Reduce, Share, Transfer or Accept risk
Reduce, Share, Transfer or Accept risk
Reduce, Share, Transfer or Accept risk
Risk Response Matrix
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Summary Risk Assessment Process
Reveals critical tasks in operationsPossibilities for disruption
Likelihood and impact ratingAppropriate response strategy
ToolsRisk event logRisk Severity MatrixRisk Response Matrix