CCOP, MBCCOP

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CCOP, MBCCOP Research BasePrincipal
Investigator and Administrator MeetingBreakout
Session Drug Distribution

• Connie Szczepanek, RN, BSN
• Grand Rapids CCOP

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Grand Rapids CCOPService Region
COMPONENTS 1. Spectrum Health, Grand Rapids 2.
Battle Creek Health System, Battle Creek 3.
Hackley Hospital, Muskegon 5. Metro Health
Hospital, Grand Rapids 6. Munson Medical Center,
Traverse City 8. Saint Mary's Health Care, Grand
Rapids   AFFILIATE 9. Mecosta County General
Hospital, Big Rapids BASIC SCIENCE
MEMBER VanAndel Research Institute, Grand Rapids
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Primary Qualifiation
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The GRCOP Toolbox IDM

• Investigational Agents
• Central Pharmacy
• Protocol start-up management
• QA
• Education

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Investigational Agents

• Ordering
• Tracking
• Next Due
• Expiration
• Labeling
• Drugs Dispensed
• Patient Returns

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TOOLS Use of provided drug

• Chart labelsplaced in clinic chart
• Highlight on protocol menu/pocket cards/web index

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Central Pharmacy Communication!

• Early Notificationpotential patients
• Preordering
• Drug Ordering Process
• Alerts
• Drug info changes
• PMB notices
• Study updates
• In-the-loop team communications

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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

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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

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Ongoing QA

• All active drug trials monitoredall sites
• Monthly QA of site inventory, expiration dates
• Site findings/data compared to central pharmacy
  and GRCOP office records

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Education

• IDM/PMB guidelines
• Onsite orientationall pharmacy personnel
• New patient notification start date, drug
• Ongoing dialogue
• Sample Documentation
• Annual competency component
• In-the-loop team communications

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Our secret weapon

• Dedicated CRA focus
• Special acknowledgement Sandra Tinker, CPhT