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Patient Misuse and Investigator Fraud in Clinical Trials: What Can Be Done? Part I
GCP Is a System of Shared Responsibilities
FDA Monitoring of Clinical Research
Program Objectives
PPT Slide
Clinical Investigator Inspections FY 92-99
Clinical Inspections - Domestic FY’99
Clinical Investigator Deficiency Categories* - FY 99
Clinical Investigator Deficiency Categories: FY 97-99
Regulatory Actions (Clinical Investigations)
Inspection Outcomes (1964-1999)
IRB Inspections
Institutional Review is a Critical Component of GCP
FDA Recognizes the Importance of IRB Inspections to Implementing GCP
IRB Deficiencies - FY’99
IRB’s: What We Observe
IRB’s: Observations as Symptoms
Human Subject Protection Is Not Just IRBs: Current Issues
Impact of Misconduct
Current Compliance Concerns
Complaints Received: 92-99*
Detecting and Handling Scientific Misconduct and Persistent Noncompliance
Detecting and Handling Scientific Misconduct
Fiddes Case Background
New York Times May 17, 1999 RESEARCH FOR HIRE: SECOND OF TWO ARTICLES
NY Time Allegations 100% source data verification = False sense of security
Tip for Detecting Serious Misconduct
NY Times Allegation The Slight of Hand Maneuver
NY Times Allegation The Emperor has no clothes Syndrome
NY Times Allegation BLAMETHEMONITOR Maneuver
NY Times Allegation THENURSEDIDIT Maneuver The last refuge of a scoundrel
The Blame Game Who gets the blame?
NY Times Allegation
NY Times Article Allegation
NY Times Allegation Fabrication the undetectable crime?
How we can improve Tips for Detecting Serious Misconduct
NY TIMES Allegations
How we can improve Tips for Dealing with Serious Misconduct
Complaint Handling System Points to Consider
FDA Believes Sponsors should Promptly Report...
Source of Complaints about CIs FY 1999
Sponsor reports to DSI
Sponsor Reports to DSI
How you can help
We’re from the Government, how can we help?
Privacy Act Systems of Records
Bioresearch Monitoring Information System (BMIS)
Notice of Initiation of Disqualification Proceeding and Opportunity to Explain
Misconduct Website
Where to Report Misconduct
How You can help
Classification of IRB Inspections
IRB Classifications - FY’99
IRB Deficiencies - FY’97
IRB Deficiencies - FY’98
Stan W. Woollen, Deputy Director, Division of Scientific Investigations, Center for Drug Evaluation and Research, FDA
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Last update: July 11, 2005
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