Table of Contents
Emerging Issues in FDA’s Oversight of Clinical Research
Achievements in Clinical Research (1975-2000)
Quality Improvement: Inspection of US CI’s (CDER)
A Changing Clinical Trial “Landscape”
Some Calls to Action
Answering these Calls: FDA’s Mission
FDA’s Mission in Clinical Research is Also Broad
Good Clinical Practice
Human Subject Protection is One Facet of GCP
Answering these Calls: FDA’s Approach
Protection
Strengthening the IRB System
The Challenges
The Challenges
Protection
Protection
Protection: Enhancing FDA’s Bioresearch Monitoring Program
Responsibility: Ensuring Understanding
Responsibility: Ensuring Understanding
Responsibility: Ensuring Responsibility
Responsibility: Conflicts of Interest
Responsibility: Standards for Non-US Trials
Responsibility: Standards for Non-US Trials
Reporting: Research Misconduct
Education:
Infrastructure:
Naming the Office: Too Cold, Too Hot, and Just Right
OGCP: Structure
OGCP: Functions
OGCP: Operations
Working Together: Plentiful Opportunities
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