WELCOME TO "FUNDAMENTALS OF CLINICAL RESEARCH" ON-LINE COURSE!


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TABLE OF CONTENTS


CHAPTER 1 - FOOD AND DRUG ADMINISTRATION PAST AND PRESENT
FREE DEMO!
Section 1A Creation of the Food and Drug Administration
Section 1B Legislation and the Regulations that Govern Research and Development
Section 1C Legislation and Regulations that Protect Human Study Subjects
Chapter 1 Review
Chapter 1 Test
CHAPTER 2 - OVERVIEW OF MEDICINAL PRODUCT DEVELOPMENT
Section 2A New Drug Discovery and Pre-Clinical Research
Section 2B Clinical Research, Marketing Approval, and Post-Marketing Surveillance
Section 2C Biologics, Research and Development, and Licensing
Section 2D Medical Device Research and Development and Marketing Approval/Clearance
Chapter 2 Review
Chapter 2 Test
CHAPTER 3 - GOOD CLINICAL PRACTICE (GCP)
Section 3A Investigational New Drug Application 21 CFR 312: Sponsorís Obligations
Section 3B Investigational New Drug Application 21 CFR 312: Investigatorís Obligations
Section 3C Institutional Review Board 21 CFR 56, Protection of Human Subjects 21 CFR 50, Financial Disclosure 21 CFR 54
Chapter 3 Review
Chapter 3 Test
CHAPTER 4 - INTERNATIONAL CONFERENCE OF HARMONIZATION
Section 4A International Conference of Harmonization History
Section 4B ICH/GCP (E6) Consolidated Guideline and ICH (E2A) Clinical Safety
Chapter 4 Review
Chapter 4 Test
CHAPTER 5 - CLINICAL TRIAL DEVELOPMENT
Section 5A Protocol Design and Development
Section 5B Case Report Form Development, Query Resolution, and Expanded Access to Investigational Product(s)
Chapter 5 Review
Chapter 5 Test
CHAPTER 6 - CLINICAL TRIAL MANAGEMENT
Section 6A Investigator Site Perspective: Coordinating a Clinical Trial at the Site
Section 6B Sponsor’s Perspective: Managing a Multi-Center Clinical Trial, and FDA Audits
Chapter 6 Review
Chapter 6 Test
CHAPTER 7 - MONITORING OBLIGATIONS AND METHODS
Section 7A Monitoring Obligations per FDA and ICH (E6) Guidelines
Section 7B Monitoring Responsibilities and Methods
Chapter 7 Review
Chapter 7 Test