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CCOP, MBCCOP Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution

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CCOP, MBCCOP Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution

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    1. CCOP, MBCCOP & Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution Connie Szczepanek, RN, BSN Grand Rapids CCOP

    2. Grand Rapids CCOP Service Region

    3. Primary Qualifiation

    4. The GRCOP Toolbox: IDM Investigational Agents Central Pharmacy Protocol start-up & management QA Education

    5. Investigational Agents Ordering Tracking Next Due Expiration Labeling Drugs Dispensed Patient Returns

    6. TOOLS: Use of provided drug Chart labels—placed in clinic chart Highlight on protocol menu/pocket cards/web index

    7. Central Pharmacy: Communication! Early Notification—potential patients Preordering Drug Ordering Process Alerts Drug info changes PMB notices Study updates “In-the-loop” team communications

    8. Protocol Startup Protocol evaluated for feasibility and special management issues Discussed at Network Team Meeting Findings forwarded to PI and (CAC) Advisory Board Review Routed to pharmacy

    9. Protocol Startup Ordering information abstracted/verified at time of study initiation Forwarded to Pharmacy for reference & process initiation Filed in master protocol for all staff to reference

    10. Ongoing QA All active drug trials monitored—all sites Monthly QA of site inventory, expiration dates Site findings/data compared to central pharmacy and GRCOP office records

    11. Education IDM/PMB guidelines Onsite orientation—all pharmacy personnel New patient notification: start date, drug Ongoing dialogue Sample Documentation Annual competency component “In-the-loop” team communications

    12. Our secret weapon Dedicated CRA focus Special acknowledgement: Sandra Tinker, CPhT

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