Emerging Issues in FDAs Oversight of Clinical Research

2/7/02


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Table of Contents

Emerging Issues in FDAs Oversight of Clinical Research

Achievements in Clinical Research (1975-2000)

Quality Improvement: Inspection of US CIs (CDER)

A Changing Clinical Trial Landscape

Some Calls to Action

Answering these Calls: FDAs Mission

FDAs Mission in Clinical Research is Also Broad

Good Clinical Practice

Human Subject Protection is One Facet of GCP

Answering these Calls: FDAs Approach

Protection

Strengthening the IRB System

The Challenges

The Challenges

Protection

Protection

Protection: Enhancing FDAs 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

Author: CDER USER