223.705.81 Clinical Vaccine Trials and Good Clinical Practice (GCP)
- International Health
- 4th term
- 4 credits
- Academic Year:
- 2017 - 2018
Before enrolling in Clinical Vaccine Trials and Good Clinical Practice (GCP), you must have successfully completed Introduction to Online Learning (550.002.81), offered by the Distance Education Division. For more information and to register, go to http://courseplus.jhu.edu/core/index.cfm/go/course.home/cid/90/
Clinical Vaccine Trials and Good Clinical Practice (GCP) provides students with background and tools needed to guide conduct of Phase I and II clinical vaccine trials in a healthy population according to the standards of GCP. Addresses both FDA Code of Federal Regulations and ICH GCP Guidelines needed for domestic and international clinical trials. Introduces the following topics: vaccine administration and types, phases of clinical trials, GCP guidelines and human subjects protection including the responsibilities of ethical review committees and sponsors, steps to develop and implement a vaccine trial protocol including product management, data collection and management, quality assurance and quality control (QA/QC), recruitment and community outreach, and safety management and reporting.
- Learning Objectives:
- Develop documents and resources required for the design, enrollment, and conduct of real-world clinical vaccine trials in accordance with the international GCP and the US Food and Drug Administration (FDA) regulations.
- Understand the ethical framework and standards of GCP with special consideration given when clinical trials enroll children or are conducted in resource-poor settings.
- Develop processes for operational tasks including: collection and management of study data, quality assurance/quality control (QA/QC) oversight, and proper maintenance and monitoring of study products.
- Develop study procedures and related materials for the conduct of a trial from community education and recruitment of vaccine trial volunteers to enrollment and subsequent identification, management, documentation, and reporting of adverse events and serious adverse events.
- Methods of Assessment:
Group Project (40%)
Individual Assignments (25%)
Final Exam - open book (20%)
Class Participation - LiveTalks and quizzes (15%)
- Enrollment Restriction:
No Undergraduate Students
- Instructor Consent:
No consent required
- Special Comments:
No auditors or undergraduates.