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ACR 624: Biostatistics for Clinical Trials
4.00 Credits
Saint Cloud State University
Statistical tools used in the design, monitoring, and analysis of clinical studies, including an overview of regulatory guidance.
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ACR 624 - Biostatistics for Clinical Trials
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ACR 626: Evidence-Based Medicine
3.00 Credits
Saint Cloud State University
Published clinical evidence. Practice and principles of evidence-based medicine relating to common chronic diseases and conditions. The relationship between published evidence and the role of medical devices, pharmaceuticals, and combination products.
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ACR 626 - Evidence-Based Medicine
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ACR 628: Regulatory Compliance and Research Ethics
3.00 Credits
Saint Cloud State University
Regulations associated with research ethics, regulatory and global standards for research conduct, and how to problem solve real-world cases. Regulations and standards for clinical trials. Communication and ethical considerations in negative product-performance situations.
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ACR 628 - Regulatory Compliance and Research Ethics
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ACR 630: Clinical Study Design and Planning
3.00 Credits
Saint Cloud State University
Protocol development, study design selection, budgeting, investigational plan requirements, and site selection. Legal and regulatory aspects.
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ACR 630 - Clinical Study Design and Planning
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ACR 632: Clinical Study Operations and Execution
3.00 Credits
Saint Cloud State University
Structure, practices, processes, systems, and insights necessary to effectively manage the training, startup, and initial management of clinical research studies.
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ACR 632 - Clinical Study Operations and Execution
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ACR 634: Clinical Risk Management and Safety
3.00 Credits
Saint Cloud State University
Structure, practices, and processes necessary to effectively manage clinical research studies from study initiation to study closure, focusing on study risk mitigation.
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ACR 634 - Clinical Risk Management and Safety
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ACR 636: Communications and Reporting for Clinical Trials
3.00 Credits
Saint Cloud State University
Regulatory reporting requirements related to the clinical research of medical products. Communication skills and required documentation.
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ACR 636 - Communications and Reporting for Clinical Trials
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ACR 640: Clinical Research Leadership
3.00 Credits
Saint Cloud State University
Roles and responsibilities in leadership. Clinical leadership, integration of cross-functional objectives, and critical thinking.
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ACR 640 - Clinical Research Leadership
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ACR 641: Communication for MedTech Professionals
1.00 Credits
Saint Cloud State University
Medical/scientific writing skills, with professional development involving oral presentations, self-awareness and self-management, business etiquette, and working on a team.
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ACR 641 - Communication for MedTech Professionals
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ACR 644: Internship: Graduate Masters Level
1.00 - 12.00 Credits
Saint Cloud State University
Credit for off-campus professional experience with industry partners, non-profit organizations or government agencies. Can serve as a graduate culminating experience in conjunction with a portfolio demonstrating mastery of associated learning outcomes.
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ACR 644 - Internship: Graduate Masters Level
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