223.705.81 Clinical Vaccine Trials and Good Clinical Practice (GCP)
- International Health
- 4th term
- 3 credits
- Academic Year:
- 2012 - 2013
Provides students with background and tools needed to implement Phase I and II clinical vaccine trials in a healthy population according to the standards of Good Clinical Practice (GCP). Addresses both FDA Code of Federal Regulations and ICH GCP Guidelines needed for domestic and international clinical trials. Includes the following topics: review of vaccine history and types; discussion of phases of vaccine trials; development and implementation of a vaccine protocol; GCP guidelines; roles and responsibilities of the investigator and designees; ethical review committees and sponsors; budget development; product management; human subjects protection; and data collection and management, recruitment, community outreach, and overall trial conduct.
- Learning Objectives:
- Approach the vaccine trial process as a dynamic team effort conducted within ethical and regulatory guidelines
- Identify the primary objectives of a vaccine trial and explain how they are evaluated
- Describe the components required to conduct a successful clinical vaccine trial
- Explain the regulatory requirements and their application in clinical vaccine trials
- Identify key ethical issues in human subjects protection in clinical trials
- Identify key considerations in the development of an informed consent form
- Examine principles of community education and recruitment of vaccine trial volunteers
- Formulate clinical vaccine protocol documents
- Explain how vaccine development impacts public health
- Explain and apply the practical aspects of designing and enrolling a clinical trial
- Methods of Assessment:
Student evaluation based on participation and completion of individual and group projects.
- Instructor Consent:
No consent required
- Special Comments:
No auditors or undergraduates.