223.705.81 CLINICAL VACCINE TRIALS AND GOOD CLINICAL PRACTICE (GCP)
- International Health
- 4th term
- 4 credits
- Academic Year:
- 2013 - 2014
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:
- Apply Good Clinical Practice (GCP) certification to the design, enrollment, and conduct of real-world clinical vaccine trials in accordance with the international GCP and the U.S. Food and Drug Administration (FDA) regulations
- Develop documents and resources required to conduct a successful clinical vaccine trial including essential regulatory documents, operational sections of a clinical protocol and an informed consent in compliance with human subjects protection requirements
- Adapt clinical trial standards of GCP for use in special circumstances including enrolling children and conducting vaccine trials in resource-poor settings
- Create tools and procedures for community education and recruitment of vaccine trial volunteers
- Develop processes for data collection, management and quality assurance/quality control (QA/QC) oversight of a clinical trial with a focus on corrective action and preventive action (CAPA)
- Develop a standard operating procedure for identification, management, documentation and reporting of adverse events and serious adverse events
- 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.