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Course Criteria
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3.00 Credits
This course provides an overview of pharmacology, highlighting pharmacodynamics and pharmacokinetics, both of which are necessary to understand new drug discovery and development. A review of selected therapeutic areas will be reviewed, including oncology, cardiovascular, central nervous system, and anti-infectives. Credits: 3 hours
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3.00 Credits
The course is designed to allow the student to develop an understanding of the use and importance of statistics in drug development. This course will teach the fundamental statistical concepts used in the design, analysis and regulatory review of clinical studies and drug dossiers. It will provide an understanding of the basic statistical theory used in the interpretation of clinical trial efficacy and safety results. It will give the student an understanding of the statistical requirements applied by regulatory agencies in their review processes. Credits: 3 hours
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3.00 Credits
This course covers the planning, development, implementation and management of clinical trials. Topics include regulations, protocol development, case report form design, clinical data management operation, writing and conducting informed consent, Institutional Review Boards, contracting, budget development, selection and evaluation of research sites and activities required for implementation of a clinical trial. Prerequisites & Corequisites: Prerequisite: CTA 5000. Credits: 3 hours
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3.00 Credits
The course builds on the content of Clinical Study Administration I and presents the steps necessary to initiate, monitor, and close clinical trials within the context of Food and Drug Administration (FDA) regulations, Canadian Health Protection Branch regulations, and International Conference on Harmonization guidelines for Good Clinical Practices. Topics include: study monitoring, source document review, drug and device distribution and accounting, data correction and management, adverse event reporting, auditing and preparing for FDA inspection, Data review and summaization and final study reports. Prerequisites & Corequisites: Prerequisite: CTA 5300. Credits: 3 hours
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3.00 Credits
Generally, biomedical professionals are expected to learn the high standards of their chosen profession by example and experience. In the area of clinical trials that involve human volunteers, the assimilation of ethical standards cannot be left to chance. Personnel involved in clinical trials must balance the dual goals of scientific merit and ethical acceptability. Ethical principles (respect for autonomy, non-maleficence, beneficence, justice), and other ethical concerns (privacy, confidentiality, compassion, relationships among patients and professionals) are studied and applied to contemporary problems in medicine and clinical research. This course is designed to be practical, incorporating the use of case studies that illustrate problems arising in the design and conduct of research trials. Credits: 3 hours
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3.00 Credits
Intensive investigation of career and employability skills in Career and Technical Education. Included are the concepts required to develop skills and behaviors that will prepare students for the world of work. This course is approved as a writing-intensive course which fulfils the baccalaureate-level writing requirement of the student's curriculum. Credits: 3 hours
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3.00 Credits
Analysis of the teaching/learning process for professionals employed in non-school settings. Included are communication and education skills, interviewing and counseling techniques, teaching methods and evaluation strategies. Prerequisites & Corequisites: Prerequisite: FCS 2600. Credits: 3 hours
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3.00 Credits
This course is designed to prepare students for the responsibilities of classroom instruction. Emphasis is placed on student classroom management, assessment, and evaluation strategies. Requires a minimum of one (1) day per week participating in a classroom. Prerequisites & Corequisites: Prerequisites: CTE 5420 and 3440. Notes: May be taken concurrently with ED 305. Credits: 3 hours
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2.00 Credits
The seminar will be directly related to the student intern's teaching experiences within the field of career and technical education. The seminar will further the student's practical understanding of important facets of the art and science of teaching including creating a productive learning environment, advancing student learning in subject matter areas and workplace readiness while improving teaching practice through professional development and outreach with business, professional, family, and community partners. The seminar will be designed to develop reflective practitioners through the use of discussion, learning journals, and the development of a professional teaching portfolio. Must be taken concurrently with CTE 4750. Credits: 2 hours
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10.00 Credits
This course represents the final field experience of the student's curriculum during which an application of all knowledge and skills acquired is facilitated. Through the experiences provided in this course, students develop the skills and knowledge necessary for certification as a career and technical education teacher in the state of Michigan. Must be taken concurrently with CTE 4100. Credits: 10 hours
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