This document summarizes a collaboration between Datatrak International and Durham Technical Community College to develop innovative learning opportunities in clinical research. The collaboration began in 2008 to address industry needs through a clinical trials research degree program at DTCC. This involved developing certificate programs in areas like clinical data management. The collaboration aims to prepare students for various entry-level clinical research positions through a combination of traditional and online instruction, using real-world tools and industry examples. There are plans to continue and expand the collaboration to other courses and programs.

1. Innovative Learning Opportunities:
A Collaboration between Industry and Academia
William Gluck, Ph.D.
VP, DATATRAK Clinical and Consulting Services
Datatrak International, Inc.

2. Disclaimer
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3. Agenda
• A Brief History
• The Need
• The Program
• The Collaboration
• Examples of How the Collaboration Works
• Questions
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4. History of the Collaboration
• 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
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5. Addressing Needs
• The role of the community college
• Economics
• Re-Engineering a career
• Responding to the need
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6. CTRA Program Overview
• The DTCC CTRA program prepares individuals
for a variety of entry-level positions
► Clinical Research/ Clinical Operations
 Pharmaceuticals/Biotechnology/Medical Devices
 CROs
 Research Sites
► ClinicalData Management
► Regulatory Affairs/Quality Assurance/Auditing
► Product Safety/ Pharmacoviligance
► Biostatistics/ Medical Writing
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7. Program Evolution
• Traditional classroom instruction
• Hybrid approach
• Online or eLearning today
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8. Certificate Program
• 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)
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9. Incorporating Medical Devices in the Mainstream
Curriculum
• Curriculum must address all aspects of the
industry
► Focus on fundamentals of CDM
► Focus on industry
 Medical Devices
 Biotechnology
 Pharmaceuticals
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10. Evaluations – Preparation for the Real World
• 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
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11. Future Plans
• Continue the collaboration – it works!
► Studentevaluations are positive
► Placement and workplace demand
• Expand the Collaboration
► Expand to other courses in the program
► Potential to expand into other programs…
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12. ®
from Concept to Cure
with DATATRAK ONE™
DATATRAK International
Cleveland, Ohio
Bryan, Texas
Cary, North Carolina
888.677.DATA (3282) Toll Free
www.datatrak.net