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.
The course includes the following topics: review of vaccine history and vaccine types, discussion of vaccine trial phases, development and implementation of a vaccine protocol, GCP guidelines, human subjects protection, responsibilities of ethical review committees and sponsors, product management, data collection and management, quality assurance and quality control (QA/QC), recruitment and community outreach, safety management and reporting, and overall trial conduct.
Upon successfully completing this course, students will be able to:
Graduate students interested in vaccines and vaccine trials.
Please note that Clinical Vaccine Trials and Good Clinical Practice (GCP) is not open to undergraduate students.
Student evaluation is based on 2 Group Projects (40%), 2 Individual Exercises (25%), Final Exam (20%), Self-Assessment Module Quizzes (5%) and participation (live talks and peer evaluation) (10%).
This is a four-credit course that runs for eight weeks. We have organized the course materials into seven modules and thirteen lectures. You are expected to budget your time so that you complete the lectures and assignments in the appropriate time. Review the Course Content page for each assignment date and deadline.
Time Commitment: The most recent student course evaluations indicate that:
77% spent 15 or less hours on the course per week
19% spent 16 or more hours
The course assignments are designed as practical exercises to help you understand the complexities of the conduct of vaccine trials and to help you deal with various issues or problems that may arise. They include: group exercises; individual exercises;discussions and participation
Development of vaccine protocol: You will each be assigned to a global health issue to work on throughout the term:
ETEC (enterotoxigenic E. coli)
Respiratory syncytial virus (RSV)
We will provide you with a sample protocol template for each global issue. You must refer to and amend this protocol to complete these assignments. In a group, you will create a protocol summary, inclusion and exclusion criteria, an educational brochure, and recruitment material. You will receive detailed instructions for each exercise. Individually, you will complete an Adverse Event Simulation, Informed Consent Form and a Final Open Book Exam.
Other required exercises: The remainder of the course grade will be based on
|Course Exercise Guide|
|Title||Exercise||Protocol Template Needed||Percent|
|IE1||Individual Exercise 1: Informed Consent Form||Yes||20|
|GE1||Group Exercise 1: Protocol Summary, Inclusion/Exclusion Criteria and Study Schedule||Yes||20|
|GE2||Group Exercise 2: Community Education and Recruitment||Yes||20|
|IE2||Individual Exercise 2: Adverse Events Simulation||No||5|
|--||Participation: 4 LiveTalk and Peer Evaluation||No||10|
|--||Final Open Book Exam||Yes||20|
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/
This course is graded on a strict point system as described below. Do not expect a curve.
|Total Percentage||Course Grade|
|59 or below||F|
|Note: C or above = "Pass" for those taking the course pass/fail|
Required materials for the course are described below:
We recognize that there are students from across the globe taking this course. We ask that each of you be courteous and cooperative with time zone and other issues of your fellow classmates. Please be sure that everyone has an opportunity for input and actively participates in the group assignments. If there are significant problems, contact the TA or instructor at firstname.lastname@example.org before due dates.
Concerns about course topics and assignments
Technical concerns about the functionality and operation of course Web pages (before emailing, please make sure that you can replicate the problem)
Technical help with JHSPH email or desktop applications
Feedback from students each year has greatly enhanced the course.
We do listen. Student feedback has greatly shaped revisions to this course. Please take the time to give us yours.
Each LiveTalk session will be offered once. See Course Schedule for dates and times.
If you are not able to attend a LiveTalk session, to receive credit for the LiveTalk you must read/listen to the archive of the LiveTalk session and post a response to the Discussion Forum under the appropriate category "LiveTalk Makeup."
Please see the course schedule for a full list of dates and items for this course.
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Students should be familiar with the policies and procedures specified under Policy and Procedure Manual Student-01 (Academic Ethics), available on the school’s http://my.jhsph.edu portal.
The faculty, staff and students of the Bloomberg School of Public Health and the Johns Hopkins University have the shared responsibility to conduct themselves in a manner that upholds the law and respects the rights of others. Students enrolled in the School are subject to the Student Conduct Code (detailed in Policy and Procedure Manual Student-06) and assume an obligation to conduct themselves in a manner which upholds the law and respects the rights of others. They are responsible for maintaining the academic integrity of the institution and for preserving an environment conducive to the safe pursuit of the School's educational, research, and professional practice missions.
We expect you to complete assignments on time. We can't issue grade reports until we receive all assignments. Therefore, to be fair to other students, we will penalize unapproved late submissions incrementally per day. If illness or special circumstances impact completing an assignment on time, students are required to contact the instructor or TA prior to the due date to discuss options.