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ACTION. Accelerating Clinical Trials Integration and Overcoming Non-value-add Kelly Paulson Mayo Clinic Cancer Center. Project Introduction. Purpose: Improve performance of key processes associated with conducting clinical trials that are PI initiated with industry support

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  1. ACTION Accelerating Clinical Trials Integration and Overcoming Non-value-add Kelly Paulson Mayo Clinic Cancer Center

  2. Project Introduction • Purpose: Improve performance of key processes associated with conducting clinical trials that are PI initiated with industry support • Goal: 20% reduction; anticipated: 50% reduction • Timeline: January – December, 2009 • Collaborative effort with Cancer Center, IRB, Legal, Budgeting

  3. What Worked Well - Project • Dedicated Project Manager and Quality Improvement Expert • Active involvement from major players (IRB, Legal, physicians, etc.) • Voice of the customer • Ongoing communication • DMAIC process • Metrics

  4. What Worked Well - Project • Dedicated IT resources & website • Recognize what you cannot/should not change • Value stream maps – visual representation • Sharing responsibility/accountability among the 10 teams

  5. Project Teams • Protocol Development • Budgeting • Disease Oriented Groups • Protocol Activation • Case Report Forms • Training • Ancillary Committees • IT • Internal Communications • External Communications (Sponsors)

  6. Value Stream Map

  7. What Worked Well – Changes • Earlier start • Combining activities/forms • Standardize processes • Eliminate duplication/manual processes • Eliminate PI admin responsibilities • Creating templates/training materials/dashboards

  8. Training Pathway

  9. Protocol Management Tool

  10. Challenges • Staying committed to deadlines along with other work obligations • Training • Accountability – sustaining changes • Some processes are out of our control

  11. Questions?

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