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Available
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Assignment
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Due
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Introduction
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Thu, Aug 27
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Lecture 0
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Course Overview (Charron)
Introduction: Vaccine Trials and the Scientific Method (Cox)
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Mon, Sep 7
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Thu, Sep 3, 4 PM
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LiveTalk 1
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Course Introduction 4:00-5:00PM Optional
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——
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Module 1: Vaccine Clinical Trials: Basic Framework
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Thu, Aug 27
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Lecture 1
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Types of Vaccines, How Vaccines Are Administered, and the Vaccine Development Process (Halsey)
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Mon, Sep 7
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Thu, Aug 27
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Lecture 2
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Development of a Vaccine Protocol and Sample Size Selection (Charron, Moulton, Zimmerman)
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Mon, Sep 7
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Thu, Aug 27
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Lecture 3
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Characteristics and Outcomes of Vaccine Trials (Harro)
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Mon, Sep 7
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Thu, Aug 27
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Quiz
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Module 1
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Mon, Sep 7, 9 AM
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Thu, Aug 27
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GROUP EXERCISE 1 (GE1)
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Part I—PowerPoint for LiveTalk 2
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Tue, Sep 8, 9 AM
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——
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GROUP EXERCISE 1 (GE1)
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Part II—Development of Protocol Concept, Inclusion/Exclusion Criteria and Study Schedule
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Fri, Sep 18, 9 AM
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Thu, Sep 10, 5 PM
—
Thu, Sep 10, 6:30 PM
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LiveTalk 2
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Discussion: GE1 Protocol Title and Community Discussions
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——
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Module 2: Budget Development
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Fri, Sep 4
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Lecture 4
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Vaccine Trial Budget Development (Harro)
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Mon, Sep 14
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Fri, Sep 4
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Quiz
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Module 2
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Mon, Sep 14, 9 AM
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Mon, Sep 7
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INDIVIDUAL EXERCISE 1 (IE1)
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Informed Consent Form
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Fri, Sep 25, 9 AM
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Module 3: Protection of Human Subjects
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Fri, Sep 11
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Lecture 5
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Protection of Human Subjects (Cox)
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Mon, Sep 21
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Fri, Sep 11
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Quiz
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Module 3
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Mon, Sep 21, 9 AM
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Module 4: Regulations and Trial Management
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Fri, Sep 18
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Lecture 6
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Vaccine Management and Preparation (Kim)
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Mon, Sep 28
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Fri, Sep 18
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Lecture 7
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Data Management, Quality Assurance, and Quality Control (Charron)
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Mon, Sep 28
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Fri, Sep 18
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Quiz
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Module 4
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Mon, Sep 28, 9 AM
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Module 5: Community Involvement
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Mon, Sep 21
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GROUP EXERCISE 2 (GE2)
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Community Education
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Mon, Oct 5, 9 AM
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Mon, Sep 21
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Peer Evaluation
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Mandatory Form with Guidelines
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Mon, Oct 5, 9 AM
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Fri, Sep 25
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Lecture 8
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Community Involvement and Recruitment (Charron and Williams)
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Mon, Oct 5
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Fri, Sep 25
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Quiz
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Module 5
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Mon, Oct 5, 9 AM
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Tue, Sep 29, 5:30 PM
—
Tue, Sep 29, 6:30 PM
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LiveTalk 3
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Vaccine Trials in Resource-Poor Settings
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——
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Module 6: Study Initiation and Screening
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Fri, Oct 2
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Lecture 9
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Pre-Study and Study Initiation (Charron)
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Mon, Oct 12
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Fri, Oct 2
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Lecture 10
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Screening Volunteers (Charron)
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Mon, Oct 12
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Fri, Oct 2
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Quiz
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Module 6
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Mon, Oct 12, 9 AM
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Module 7: Vaccine Protocol Conduct
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Wed, Oct 7
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Preparation for LiveTalk
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For LiveTalk 4: FDA Warning Letter
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Wed, Oct 14, 9 AM
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Fri, Oct 9
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INDIVIDUAL EXERCISE 2 (IE2)
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Adverse Events Simulation
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Mon, Oct 19, 9 AM
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Fri, Oct 9
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Lecture 11
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Enrollment and Implementation Procedures (Charron)
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Mon, Oct 19
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Fri, Oct 9
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Lecture 12
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Safety Assessments and Management of Adverse Events (Durbin)
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Mon, Oct 19
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Fri, Oct 9
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Quiz
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Module 7
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Mon, Oct 19, 9 AM
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Thu, Oct 15, 5:30 PM
—
Thu, Oct 15, 6:30 PM
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LiveTalk 4
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Warning Letter Discussion
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——
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Final Open Book Exam
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Fri, Oct 16
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Exam
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Final Open Book Exam
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Wed, Oct 21, 9 AM
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Course Evaluation
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Wed, Oct 14
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Course Evaluation
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Course Evaluation Form
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Tue, Oct 27
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