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Good Clinical Practice: a Vaccine Trials Perspective

Prerequisite:

Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses.

Description:

When threats such as Zika, Ebola, and COVID-19 emerge, there is an urgent call for effective vaccines to prevent these infectious diseases. However, new vaccines or investigational products must be rigorously evaluated through research studies conducted according to Good Clinical Practice (GCP). These international standards guide the design and conduct of trials involving human subjects and provide a critical framework for study teams to recruit and enroll study participants, collect high-quality data, and maintain records, which comply with federal and international regulations. Assignments for this course use vaccine trials as an example of clinical trial conducted according to GCP.

Acquaints students with the regulatory and ethical standards of conducting trials in accordance with FDA Code of Federal Regulations and ICH GCP Guidelines. Provides students with background and resources needed to conduct clinical trials in healthy populations. Completes a project based on a real-world vaccine trial focusing on logistical and operational components of protocol design, informed consent process, recruitment considerations, human subjects protection including adverse event assessments and reporting. Includes the responsibilities of ethical review committees, principal investigators, and sponsors; investigational product management and preparation; data collection methods; quality assurance and quality control (QA/QC). Offers contributors to the course who have experience conducting clinical trials research in various settings.

Learning Objectives:

Upon successfully completing this course, students will be able to:

1. Apply the ethical framework and standards of Good Clinical Practice (GCP) to clinical trials with special consideration for vaccine trials and trials enrolling children or conducted in resource-poor settings
2. Identify and differentiate the roles and responsibilities of clinical trial stakeholders including sponsors, investigators, institutional review boards (IRBs), and regulatory authorities
3. Plan study procedures and create related materials for the safe conduct of a trial from recruitment to enrollment, management of study products, and monitoring of adverse events and serious adverse events
4. Formulate processes for operational tasks including: collection and management of study data, maintenance of essential documents, quality assurance/quality control (QA/QC) oversight, and monitoring
5. Design a clinical trial to define and measure public health problems in low-resource settings including the design, ethical and good clinical practice considerations, and implementation of the study that answers a relevant quantitative research question of concern to disadvantaged populations

Methods of Assessment:

This course is evaluated as follows:

• 80% Written Assignment(s)
• 20% Participation

Enrollment Restriction:

No auditors or undergraduate students

Instructor Consent:

Consent required for all students

Consent Note:

all students must request consent of the instructor

For consent, contact:

bjohns71@jhu.edu