This course provides the CAF student with a broad overview of clinical research as applied to the development of biotechnology, pharmaceutical and medical device products. Clinical research will be considered within the corporate, legal, and regulatory environments within which the industry operates. The course will consider key issues concerning the design and execution of successful clinical development programs.
- Use the key components in the regulatory affairs and clinical development life cycles and interpret their relationship.
- Distinguish the value of the product label as a guide to development.
- Examine the basics of Good Clinical Practice.
- Judge the structure and content of a Clinical Trial Protocol and an Investigator Brochure.
- Support the regulatory and ethical basis for the protection of human subjects and clinical trial safety monitoring.
- Evaluate the key components of clinical trial management, including site selection and management, contracts and budgets, and clinical trial monitoring.
- Design the general process for data collection and processing including development of case report forms, data management strategy, and statistical analysis plans.
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