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Clinical Vaccine Trials and Good Clinical Practice Online Course

This is a three-credit online course taught through the Johns Hopkins Bloomberg School of Public Health Distance Education Division. The course is divided into eight modules and fifteen lectures, which are to be completed in order over an eight-week period.

This course provides students with background and tools needed to implement Phase I or II clinical trials in a healthy population according to the standards of GCP using a high-tech approach that includes streaming audiovisual materials and asynchronous and synchronous components. Students are evaluated through a series of individual and group projects that apply GCP principles to creating vaccine protocol. Course topics include:

  • Review of vaccine history and types
  • Discussion of phases of vaccine trials
  • Development and implementation of a vaccine protocol
  • U.S. FDA regulations for clinical trials
  • GCP guidelines
  • Roles and responsibilities of the investigator and designees
  • Ethical review committees and sponsors
  • Budget development
  • Investigational product management
  • Human subjects protection
  • Data collection and management
  • Quality assurance/quality control
  • Recruitment
  • Community outreach
  • Overall trial conduct including adverse event management

Here is a link to the Clinical Vaccine Trials and Good Clinical Practice course syllabus.

Basic GCP

Advanced GCP

Clinical Vaccine Trials and GCP Online Course (for credit)

Comprehensive GCP Online Course (non-credit)