Innovative Learning Opportunities: A Collaboration between Industry and Academia
William Gluck, Ph.D.VP, DATATRAK Clinical and Consulting Services
Datatrak International, Inc.
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Disclaimer
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• A Brief History • The Need • The Program • The Collaboration • Examples of How the Collaboration Works• Questions
Agenda
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• 1992 – Clinical Trials Research planning begins• 1998 – Clinical Trials Research instituted a
Durham Technical Community College (DTCC) degree program
• 2006 – Clinical Data Management certificate program developed and implemented
• 2008 – DATATRAK and DTCC collaboration begins• 2011 – Collaboration formalized• 2012 – Collaboration expanded
History of the Collaboration
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• The role of the community college• Economics• Re-Engineering a career• Responding to the need
Addressing Needs
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• The DTCC CTRA program prepares individuals for a variety of entry-level positions► Clinical Research/ Clinical Operations
Pharmaceuticals/Biotechnology/Medical Devices CROs Research Sites
► Clinical Data Management► Regulatory Affairs/Quality Assurance/Auditing► Product Safety/ Pharmacoviligance► Biostatistics/ Medical Writing
CTRA Program Overview
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• Traditional classroom instruction • Hybrid approach• Online or eLearning today
Program Evolution
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• Clinical Data Management Focus► Developed with funding from the North Carolina
Biotechnology Educational Grant program Collaborative effort Innovative approach
► Core Certificate Courses Concepts (CTR-215) Data Collection and Management (CTR-225) Data Trends and Reporting (CTR-230)
Certificate Program
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• Curriculum must address all aspects of the industry ► Focus on fundamentals of CDM► Focus on industry
Medical Devices Biotechnology Pharmaceuticals
Incorporating Medical Devices in the Mainstream Curriculum
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• Using real world tools and examples► Concepts
Devices as a key RTP industry sector► Data Collection
Collection approaches for all industry sectors► Data Reporting and Trends
Medical Device submissions The evolving device regulatory environment
Evaluations – Preparation for the Real World
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• Continue the collaboration – it works!► Student evaluations are positive► Placement and workplace demand
• Expand the Collaboration► Expand to other courses in the program► Potential to expand into other programs…
Future Plans
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from Concept to Cure
with DATATRAK ONE
DATATRAK InternationalCleveland, Ohio Bryan, Texas Cary, North Carolina
888.677.DATA (3282) Toll Freewww.datatrak.net
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