2009 Web Seminar Series Resolutions for Unexpected Site Challenges Instructors:Charlotte Royer-Malvestuto, M.Ed., MBE Jack 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.HHSN C."

2 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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4 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

5 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 Monitor/Control Implement risk strategy Monitor and adjust Change management

6 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 EventsOutcomes Shipping delaysFailure to meet schedule Toy on stairsStaff member breaks leg Snow stormOpened late

7 Risk EventOutcomeImpactLikelihood Staff turnover CTP Buy-in Miscommunication Informed Consent Errors Risk Log Revealing & Planning for Vulnerable Operations Minor Risk Moderate Risk Major Risk

8 Risk EventOutcomeImpactLikelihood Stuck in trafficMissed client meeting 44 Risk Log Driving to Work in the Rain Risk Assessment Process Minor Risk Moderate Risk Major Risk

9 Risk Assessment Process Likelihood Impact Minor Risk Moderate Risk Major Risk Risk Severity Matrix Driving to Work in the Rain

10 Risk Assessment Process Risk EventResponse to Risk Contingency Plan TriggerPerson Responsible Stuck in traffic Reduce, Share, Transfer or Accept risk Leave 30 minutes early Weather report Jack Risk Response Matrix Driving to Work in the Rain

11 Risk EventOutcomeImpactLikelihood Lag in CRF Completion Missed data/increased data queries 44 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 Minor Risk Moderate Risk Major Risk

12 Risk Assessment & Management Case Study Likelihood Impact Minor Risk Moderate Risk Major Risk Risk Severity Matrix

13 Risk Assessment & Management Case Study Risk EventResponse to Risk Contingency Plan TriggerPerson Responsible Lag in CRF Completion Reduce, Share, Transfer or Accept risk Training Time Management /Cross-train QA visit/Data Queries Project Manager Risk Response Matrix

14 Group Discussion Risk Assessment and Management Process

15 Risk EventOutcomeImpactLikelihood Risk Log Group Discussion Minor Risk Moderate Risk Major Risk

16 Group Discussion Likelihood Impact Minor Risk Moderate Risk Major Risk Risk Severity Matrix

17 Group Discussion Risk EventResponse to Risk Contingency Plan TriggerPerson Responsible Reduce, Share, Transfer or Accept risk Risk Response Matrix

18 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