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Institution:
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The University of West Florida
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Subject:
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Description:
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This course provides an overview of clinical trial operations for learners of any academic field. Subject matter focuses on the history and regulatory guidance surrounding human subjects in drug trials, including current standards of Good Clinical Practices (GCP). Course emphasizes administrative functions required in real-world clinical research, such as informed consent, protocol review, study documentation, and research staff roles and responsibilities. Course also covers the storage, shipment, and safety issues concerning pharmaceutical drugs and biologic materials. Students participate in a virtual "Mock Study" to demonstrate comprehension of course materials and ability to work as a clinical team.
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Credits:
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3.00
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Credit Hours:
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Prerequisites:
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Corequisites:
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Exclusions:
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Level:
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Instructional Type:
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Lecture
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Notes:
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Additional Information:
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Historical Version(s):
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Institution Website:
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Phone Number:
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(850) 474-2000
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Regional Accreditation:
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Southern Association of Colleges and Schools
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Calendar System:
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Semester
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