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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: Sponsor’s Obligations
Section 3B
Investigational New Drug Application 21 CFR 312: Investigator’s 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
Sponsors 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