Resolutions for Unexpected Site Challenges

1. 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."

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 • 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

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

7. Revealing & Planning for Vulnerable Operations Risk Log

8. Risk Assessment Process Risk LogDriving to Work in the Rain

9. Risk Assessment Process Risk Severity Matrix Driving to Work in the Rain Likelihood Impact

10. Risk Assessment Process Risk Response MatrixDriving to Work in the Rain

11. 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

12. Risk Assessment & Management Case Study Risk Severity Matrix Likelihood Impact

13. Risk Assessment & Management Case Study Risk Response Matrix

14. Group Discussion Risk Assessmentand Management Process

15. GroupDiscussion Risk Log

16. GroupDiscussion Risk Severity Matrix Likelihood Impact

17. GroupDiscussion 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