What Makes a Successful Clinical Research Team: The PIs Perspective

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What Makes a Successful Clinical Research Team
The PIs Perspective
Karen L. Margolis, MD, MPH Senior Clinical
Investigator HealthPartners Research Foundation
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External Players
Sponsor
IRB
Research Team
Society
Patients
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Society

• Will this study add to knowledge?
• Are risks of the study worth the knowledge to be
  gained?
• Will the results be disseminated?

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IRB

• If youve seen one IRB, youve seen one IRB
• Application
• Local issues with standard consents
• Opting in/out of substudies
• Protocol modifications
• Interim communications about AEs
• Renewals

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Sponsor

• Understand and follow protocol
• Meetings, training, monitoring visits
• Recruit and retain participants
• Personally conduct or supervise the research
• Maintain adequate and accurate records and
  regulatory documents
• Transmit study data

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Patients/Participants

• Understand and communicate risks and benefits
• Make sure participation is not coerced
• Study perks in addition to intervention
• Time
• Education
• Information

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Clinical Research Team Roles

• Investigators
• Clinic Manager
• Coordinator
• Recruiters
• Finance

• Reception
• Rooming staff
• Technicians
• Lab
• Students
• Data Entry

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Research Team Organization

• Regular staff meetings
• Knowledge and information
• Management by walking around
• Cross-training
• Flexibility
• Helpfulness

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Research Networks

• Regional
• Specialty (oncology, pulmonary, heart failure)
• Organizational (VA, HMO Research Network)
• Registries (defibrillators, cardiac surgery)

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Organizing a Network

• Must understand each clinic in network
• Monitoring
• Must disburse as well as receive funds