223.705.81 CLINICAL VACCINE TRIALS AND GOOD CLINICAL PRACTICE (GCP)
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.
1. Approach the vaccine trial process as a dynamic team effort conducted within ethical and regulatory guidelines 2. Identify the primary objectives of a vaccine trial and explain how they are evaluated 3. Describe the components required to conduct a successful clinical vaccine trial 4. Explain the regulatory requirements and their application in clinical vaccine trials 5. Identify key ethical issues in human subjects protection in clinical trials 6. Identify key considerations in the development of an informed consent form 7. Examine principles of community education and recruitment of vaccine trial volunteers 8. Formulate clinical vaccine protocol documents 9. Explain how vaccine development impacts public health 10. Explain and apply the practical aspects of designing and enrolling a clinical trial
Upon successfully completing this course, students will be able to:
Evaluate and analyze the vaccine trial process in the context of US and International ethical guidelines and regulations
Identify the primary objectives of each phase of a vaccine trial and explain how they are described in a protocol and evaluated within the design of a trial
Develop screening and operational sections of a vaccine protocol that meet FDA regulations
Identify key ethical issues in human subjects protection in clinical vaccine trials
Synthesize the GCP requirements of informed consent and create an informed consent document for a vaccine trial
Develop recruitment plan and educational materials for a vaccine trial based on established standards and guidelines
Review essential documents required for a vaccine clinical trial and establish a regulatory management system
Explain and apply practical operational techniques in designing and enrolling subjects a clinical trial
Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses..