Innovative Learning Opportunities: A Collaboration between Industry and Academia
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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Agenda • A Brief History • The Need • The Program • The Collaboration • Examples of How the Collaboration Works • QuestionsConfidential – 3
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 expandedConfidential – 3
Addressing Needs • The role of the community college • Economics • Re-Engineering a career • Responding to the needConfidential – 3
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 WritingConfidential – 3
Program Evolution • Traditional classroom instruction • Hybrid approach • Online or eLearning todayConfidential – 3
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)Confidential – 3
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 PharmaceuticalsConfidential – 3
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 environmentConfidential – 3
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…Confidential – 3
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